European Journal of Integrative Medicine 38 (2020) 101173

Contents lists available at ScienceDirect

European Journal of Integrative Medicine

journal homepage: www.elsevier.com/locate/eujim

Effects of foot reflexology on neonatal jaundice: A randomized sham- T

controlled trial
Mahdi Basiri Moghadama, Mahboubeh Esmaeilib,*, Shahla Khosravanc, Seyyed Javad Mojtabavid
a
Department of Pediatric Nursing, Faculty of Nursing and Midwifery College, Social Development and Health Promotion Research Center, Gonabad University of Medical
Sciences, Gonabad, Iran
b
Nursing and Midwifery College, Nursing and Midwifery Research Committee, Gonabad University of Medical Sciences, Gonabad, Iran
c
Department of Community and Mental Health Nursing, Faculty of Nursing and Midwifery College, Social Determinants of Health Research Center, Gonabad University of
Medical Sciences, Gonabad, Iran
d
Department of Chinese and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

A R T I C LE I N FO A B S T R A C T

Keywords: Introduction: Neonatal jaundice is considered as the most common reason for newborns’ admissions and methods
Foot reflexology to prevention this condition are therefore important. This randomized sham-controlled trial aimed to evaluate
Neonatal jaundice whether foot reflexology could affect levels of cutaneous bilirubin and reduce neonatal jaundice.
Bilirubin Methods: In this single-blind trial, sixty eligible neonates were randomly assigned to one of three groups.
Randomized controlled trial
Neonates in the foot reflexology group received genuine foot reflexology, while neonates in the sham reflexology
group received sham reflexology. These treatments were administered in four 30-min sessions on the first day of
life. . The neonates in the control group only received routine neonatal care services. Cutaneous bilirubin level,
dermal icterus, and need for phototherapy were assessed at baseline, the first, third and fifth day post-baseline
measurements. Data were analyzed by chi-square, analysis of variance, and post hoc tests.
Results: Despite the increase of cutaneous bilirubin levels after birth in three groups, it was significantly lower in
the foot reflexology group than other two groups on the first and third days but not on the fifth day (P < 0.001, P
= 0.003, and P = 0.07, respectively). Dermal icterus did not differ between the three groups at any of the
measurement time points (P > 0.05). A significant reduction was observed in the need for phototherapy in the
foot reflexology group compared with the sham reflexology and control groups (P = 0.04).
Conclusions: Foot reflexology seems to be a potentially beneficial complement for preventing or reducing
jaundice without any serious side effects. Nevertheless, larger well powered randomized controlled trials (RCTs)
are needed to confirm these findings.

1. Introduction phototherapy and blood exchange [6]. Phototherapy is widely used in

both prevention and treatment of jaundice [9,10]. Although photo-
Neonatal jaundice due to an elevated blood bilirubin level is a therapy is considered a harmless treatment, it has short-term and long-
prevalent clinical condition in Iran and the world. It affects 60 % of term side effects that are very stressful to the parents of neonates.
term and 80 % of preterm neonates in the first week of life [1–3]. Al- Electrolyte imbalance, skin rashes, dehydration, hyperthermia, reduced
though, jaundice is a transient problem, it is the most common cause of duration of exclusive breastfeeding, circadian rhythm disorder, as well
newborns’ hospitalization, accounting for 75 % of hospital admissions as DNA damage, and increased risk of childhood cancer and epilepsy
[2,4]. Neonates affected by jaundice, are more susceptible to childhood are some of side effects attributed to phototherapy [1,11–15]. Hence,
type 1 diabetes mellitus [5]. Increased level of bilirubin without proper finding safer alternative therapeutic methods are necessary to reduce
management can lead to serious complications such as encephalopathy the need for phototherapy and maintain bilirubin level at a normal
or kernicterus, hearing disturbances, seizures, and even death [5–7]. range [16]. Several causative factors lead to development of jaundice
Therefore, prevention of jaundice is more important than its treatment [17,18]. An important but preventable cause of jaundice is an increase
[8]. At present, the main treatment options for neonatal jaundice are in the enterohepatic circulation of bilirubin due to decreased intestinal

⁎
Corresponding author at: MSc in Pediatric Nursing, Department of Pediatric Nursing, Gonabad University of Medical Sciences, Near Asian Road, Gonabad, Iran.
E-mail addresses: [email protected] (M. Basiri Moghadam), [email protected] (M. Esmaeili), [email protected] (S. Khosravan),
[email protected] (S.J. Mojtabavi).

https://doi.org/10.1016/j.eujim.2020.101173
Received 23 November 2019; Received in revised form 2 July 2020; Accepted 6 July 2020
1876-3820/ © 2020 Elsevier GmbH. All rights reserved.
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

motility, delayed excretion of bilirubin-rich meconium, and absence of 0.05, test power of 0.80, and an expected dropout rate of 10 %, the total
intestinal bacteria [19]. Inhibition of enterohepatic circulation of bi- final sample size was calculated as 60 subjects, which according to the
lirubin has been reported as an effective approach in jaundice pre- study design, each group consisted of 20 neonates.
vention [20]. There are a few pharmacological and non-pharmacolo-
gical methods to disrupt enterohepatic circulation and thereby, reduce 2.2.2. Inclusion criteria
jaundice such as zinc sulfate [20], glycerin suppository [21], traditional The eligibility criteria were as follows: (1) parental informed con-
medicines [1], and manual therapies [5]. The evidence supporting sent for participation; (2) postnatal age less than 12 h; (3) cutaneous
these interventions is inconclusive and it remains controversial which bilirubin level of less than 5 mg/dl in the baseline assessment; (4) ge-
methods are more effective for clinical use [3]. Massage is one of the stational age of 37–41 weeks; (5) a fifth-minute Apgar score of more
complementary therapies which can reduce jaundice in infants. Mas- than 7; (6) no meconium excretion prior to the intervention; (7) birth
sage decreases jaundice through increasing bowel movements, facil- with non-complicated normal delivery; (8) no prohibition of foot
itating excretion of meconium, and decreasing the bilirubin level [2–4]. massage due to disease or infection; (9) exclusively breast-feeding; and
Reflexology is a massage technique and also one of the most widely (10) absence of known diseases that could affect the neonatal jaundice
used complementary therapies, which describes reflex points on the including hypothyroidism, congenital heart disease, ABO and Rh in-
ears, hands, and feet [22]. Foot reflexology is among the most popular compatibility, cephalohematoma, gastrointestinal disorder, and ob-
forms of reflexology. In foot reflexology, pressure is applied to specific vious congenital anomalies.
reflex points on the feet [23]. Foot reflexology improves the blood and
lymph circulation as well as nerve support in different parts of the body 2.2.3. Exclusion criteria
which are associated with reflex points and thereby, accelerates the The exclusion criteria were as follows: (1) day-one icter; (2) current
elimination of toxin from the body [24]. Foot reflexology is an easy, known infection in the neonate; (3) receiving phototherapy, blood
safe, and non-invasive method which can be utilized without the need transfusion, and invasive interventions in the course of the study; (4)
for special equipement [25,26]. There are very few studies into the use use of antibiotics, laxatives and bilirubin-lowering drugs; and (5)
of reflexology for children, especially for infants [27]. Previous studies transferring to another ward or hospital discharge before the comple-
have shown the beneficial effects of foot reflexology on infantile colic, tion of the intervention.
physiological indices, and acute pain after vaccination [26,28,29]. In-
fant reflexologists claim that pregnancy and birth might cause stress to 2.3. Randomization and allocation concealment
the infants’ vagus nerve, which is linked to different organs, including
the intestines [27]. Exerting pressure on the certain points on the soles The recruited newborns were divided into three groups; foot re-
of feet can contribute to stimulate the vagus nerve, stimulate gastro- flexology, sham reflexology, and control groups by permuted block
intestinal functions, and attract more nutrients [30]. The positive ef- randomization with block-sizes of six, in a ratio of 1:1:1. To conceal
fects of reflexology have been shown on intestinal functions in many assignments, a random allocation list was generated by a statistician
studies [25,31]. In a previous study, foot reflexology was found to be colleague (not involved in the trial). Each opaque envelope had a paper
effective in reducing the time of first stool excretion as well as in- marked with letter A for the reflexology group or letter B for sham
creasing frequency of defecation in healthy infants [32]. On the other reflexology group or letter C for control group in random sequences.
hand, it has been found that increased bowel movement is associated
with decreased bilirubin level and jaundice [2,6,33]. Therefore, it 2.4. Blinding
seems that foot reflexology can have an effects in preventing jaundice
by increasing the bowel movements and reducing the enterohepatic To eliminate potential bias, data analysis was performed by a sta-
circulation of bilirubin. To our knowledge, clinical trials using foot tistical analyst without prior aware of group assignments. In addition,
reflexology for the management of jaundice are relatively rare. There- outcomes evaluator was not aware of the either types of intervention or
fore, the present study was conducted to investigate the effects of foot group allocation. Nonetheless, the therapist was not blind to the details
reflexology on the prevention of neonatal jaundice. of the treatment procedure and assignments.

2. Methods 2.5. Interventions

2.1. Trial design Each eligible newborn was allocated to one of three groups and
received the relevant intervention. Foot reflexology and sham reflex-
This single-blind, randomized sham-controlled clinical trial was ology treatments were administered by the corresponding author. The
conducted from January to October 2016 on neonates admitted to the corresponding author obtained the necessary trainings for reflexology
neonatal unit of Valiasr Hospital affiliated with Birjand University of treatment under the supervision of a Traditional Chinese Medicine
Medical Sciences in Eastern Iran. To enroll the participants, when a (TCM) specialist and received a valid certificate from the Department of
newborn was admitted to neonatal unit, the corresponding author was Complementary and Chinese Medicine in Mashhad, Iran. It should be
immediately alerted. Then, the newborn was screened for eligibility by noted that due to the early discharge from the hospital, neonates in the
a qualified neonatologist and recruited into the study if he/she met the foot reflexology and sham reflexology groups were treated solely on the
inclusion criteria. After exclusion, from the 168 initial neonates, 60 first day of birth in four 30-min sessions.
were randomized into either the foot reflexology group or sham re-
flexology group or control group. Signed written informed consent form 2.5.1. Foot reflexology
was obtained from the parents of all eligible neonates prior to rando- Neonates in the foot reflexology group received genuine reflexology
mization. All neonates completed their assigned treatment program and treatment. Before beginning the intervention, the therapist washed,
post-treatment evaluations (Fig. 1). dried, and warmed her hands, placed the newborn in the supine posi-
tion, used the massage oil (made by Barij Essence Pharmaceutical Co,
2.2. Participants Tehran, Iran) to reduce the friction of her hands, and gently touched
and relaxed the right foot to warm. This phase lasted 2 min. Then, while
2.2.1. Sample size supporting the foot with the non-dominant hand, she gently pressed the
According to the results of a former study conducted in Iran [34] reflex points associated with intestines and colons on the sole of right
with considering x1 = 11.97 and x2 = 9.92 and a type I error of alpha foot using point location according to reflexology charts [35]. Light,

2
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

Fig. 1. CONSORT flow diagram of the study participants.

fast, and worm-like movements were applied with the thumb and index Transcutaneous bilirubinometer is one of the most common in-
fingers [36]. This phase lasted 13 min. The same procedure with same struments for bilirubin measurement from the skin surface in neonates,
duration was used for the left foot. The whole intervention lasted 30- to be rapid, accurate, and non-invasive [37,38]. In the present study,
min for both feet. As newborns are sensitive, a short duration of ap- cutaneous bilirubin level was measured using JH20-1A transcutaneous
plication and a soft touch sufficed. The reflexology treatment times jaundice detector, made by Ningbo David Medical Device Co., LTD. To
were adjusted accordingly to when the newborn was relaxed. Soles of use this device, its optical head was slightly pressed on the forehead
the feet were used for reflexology application because they are flat and until the skin became blanched and the amount of bilirubin displayed
more suitable [26]. on the monitor was recorded. This process was repeated three times on
the three sites of forehead and the mean value was considered as infant
2.5.2. Sham reflexology bilirubin value. Several studies found that bilirubin values measured by
Newborns in the sham reflexology group received sham reflexology transcutaneous bilirubinometer were not significantly different from
treatment. Similar to the foot reflexology group, the therapist first laboratory values [38,39]. A previous study has reported a high cor-
gently massaged and relaxed the right foot for 2 min after washing, relation between serum bilirubin and cutaneous bilirubin (r = 0.89)
drying, warming her hands, and using the massage oil. Afterwards, [40]. In the present study, to determine the reliability, 10 neonates
while supporting the foot with the non-dominant hand, gentle pressure were selected and bilirubin level was measured twice with 15- min
was exerted via direct pressure with the thumb and index fingers on the interval in each neonate. Then, the correlation between the two values
points unrelated to the gastrointestinal points on the sole of right foot, was calculated. The reliability of transcutaneous bilirubinometer was
which lasted 13 min. For the left foot, same procedure and same confirmed with a correlation coefficient of 0.82. Also, this device was
duration was applied. Duration and frequency treatment for newborns calibrated daily based on the manufacturer's instruction and its error
in the sham reflexology group was quite similar to their counterparts in was reduced to zero by a special index.
the foot reflexology group. (C) Dermal icterus
Dermal icterus was measured using the Kramer's scale, a visual tool
for distinguishing the progression of jaundice [7]. Dermal icterus first
2.5.3. Control
initiates from the head and when the bilirubin level rises, it proceeds to
In the newborns of control group, no foot reflexology or sham re-
the body and then to the extremities. On this scale, the jaundice is
flexology treatment was delivered and solely received routine neonatal
defined in 5 zones: head and neck, upper trunk, lower trunk to knees,
care services.
arms and lower legs, and palms and soles (Fig. 2) [41,42]. To assess for
dermal icterus, the newborn was placed in a room with adequate light
2.6. Outcomes and temperature (24−28 °C) and became naked. Then, appropriate
pressure was applied on the abovementioned zones until the skin was
2.6.1. Primary outcomes pale. Yellowish color of the skin was detected, if present. Serum and
(A) Daily defection frequency cutaneous bilirubin levels can be estimated based on progression of
Daily defection frequency was measured by mothers of all neonates dermal icterus [7]. The results of a study showed that the use of this
on the 1, 2, 3, and 4 days after the intervention and was recorded on the scale is helpful in low-risk newborns [43]. To determine the reliability
researcher-made checklist form. of this scale in this study, 10 neonates were examined separately for
(B) Cutaneous bilirubin level

3
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

2.7. Ethical approval and informed consent

This study was approved by the Ethics Committee of Gonabad

University of Medical Sciences, Gonabad, Iran (www.ethics.gmu.ac.ir;
No. IR.GMU.REC.1394.24) and was registered in the Iranian Registry of
Clinical Trials (www.irct.ir; No. IRCT2015100424349N1). None of
neonates were deprived of routine neonatal unit care services. Parents
of all neonates received precise information about the trial purpose and
procedure details and provided written informed consent prior to the
beginning of the study. In addition, they were assured of data con-
fidentiality and the possibility to withdraw from participation at any
time.

2.8. Data analysis

Data were analyzed using the IBM SPSS software (v. 22.0, SPSS;
Chicago, IL). The Kolmogorov-Smirnov test was used to assess the
normality of data distribution. For categorical variables, the Chi-square
test and Fisher’s exact test were used for inter-group differences. For the
quantitative variables with normal distribution, the One-way analysis
of variance (ANOVA) was calculated for inter-group differences at each
time point. For quantitative variables with non-normal distribution, the
Kruskal-Wallis test was applied to compare the inter-group differences
at each time point. The Tukey’s post hoc test was carried out with the
ANOVA test for inter-group differences at each time point. Repeated
measurement ANOVA test was used to compare inter-group differences
at four time point measurements. A P-value less than 0.05 was con-
Fig. 2. Visual assessment of dermal icterus based on Kramer’s scale. sidered statistically significant.

3. Results
dermal icterus by three experienced neonatologists and correlation
between results calculated. Acceptable reliability was obtained with
By the end of study, a total of 60 newborns completed the entire
correlation coefficient value of 0.74.
trial and could be included in the final data analysis. We did not ob-
All the neonates were evaluated for cutaneous bilirubin level and
serve any adverse events among the participants in the foot reflexology
dermal icterus at four time points: at the baseline, i.e. soon after birth,
and sham reflexology groups, and all newborns were in good health
one day afterwards, i.e. just after the intervention, third day after the
throughout the study period.
intervention, and at the end of the study on fifth day. Until discharge,
the cutaneous bilirubin levels and dermal icterus were measured at the
3.1. Inter-group comparisons of participants’ characteristics at the baseline
hospital. After discharge, the parents of the neonates were asked to take
them to the hospital on first, third, and fifth days after birth.
The percentage of female neonates in the foot reflexology, sham
reflexology, and control groups was 45 %, 55 %, and 60 %, respectively.
The most common blood group among newborn' mothers in the foot
2.6.2. Secondary outcome
reflexology and sham reflexology groups was A, and in the control
(A) Need for phototherapy
group was B. There were no significant differences in the baseline
The number of neonates who needed to phototherapy was the sec-
characteristics between the three groups (P > 0.05, for all) (Table 1).
ondary outcome measurement. If cutaneous bilirubin level was higher
Therefore, the three groups were comparable.
than the physiological range or according to the neonatologist advice,
serum bilirubin level was measured and phototherapy or other thera-
3.2. Comparison of daily defecation frequency
pies was commenced, if necessary. Also, any adverse events observed
during the trial were recorded.
The daily defecation frequency increased for all newborns during

Table 1
Inter-group comparisons of participants’ characteristics at the baseline.
Variables Groups F P value

Foot reflexology Sham reflexology Control

Mean (SD) Mean (SD) Mean (SD)

Gestational age (week) 38.65 ± 1.18 38.80 ± 1.36 38.45 ± 1.14 0.40 0.67a
Fifth-minute Apgar 9.70 ± 0.47 9.60 ± 0.68 9.70 ± 0.57 0.20 0.91b
Birth rank 1.80 ± 1.28 1.90 ± 1.02 1.60 ± 0.88 0.40 0.67a
Weight at birth (grams) 3262.50 ± 423.91 3287.50 ± 397.32 3232.50 ± 426.51 0.09 0.92a
Start of Breastfeeding (hour after birth) 1.90 ± 0.85 2.10 ± 0.85 2.00 ± 0.86 0.27 0.76a
Breastfeeding frequency (times) 9.90 ± 1.37 9.70 ± 1.34 10.00 ± 1.45 0.24 0.79a
The age of infants’ mothers (years) 27.65 ± 6.53 26.40 ± 6.92 25.50 ± 5.97 1.24 0.54a

a
The results of the One-way ANOVA test.
b
The results of the Kruskal Wallis test.

4
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

Table 2 fifth days after intervention, the dermal icterus was lower in the foot
Comparison of daily defection frequency during the first 4 days after the in- reflexology group than the sham reflexology and control groups, we
tervention. found no statistically significant difference between the groups (Exact-P
Time point Groups Test = 0.16 and Exact-P = 0.49, respectively) (Table 4). Comparison inter-
resultsa groups showed that there was no difference respecting dermal icterus at
Foot Sham Control Test 4 time-point measurements.
reflexology reflexology resultsb
Mean (SD) Mean (SD) Mean (SD)
3.5. Inter-group comparison respecting the need for phototherapy
First day 1.90 ± 0.64 1.30 ± 0.57 1.40 ± 0.68 F = 5.17 F = 2.58
P=
The results of Fisher’s exact test revealed that compared to the foot
0.009
Second day 2.50 ± 0.89 2.40 ± 0.75 2.25 ± 0.79 F = 0.48
reflexology group, the number of neonates who needed phototherapy
P = 0.62 treatment increased significantly in both the sham reflexology and
Third day 3.20 ± 1.00 3.00 ± 1.17 2.90 ± 1.12 F = 0.39 df = 2 control groups on the fifth day after the intervention (Exact-P = 0.04).
P = 0.68 Phototherapy was commenced in one newborn of the sham reflexology
Forth day 3.65 ± 0.81 3.30 ± 0.80 3.35 ± 0.87 F = 1.04 P = 0.08
group and 5 newborns of the control group.
P = 0.36

a
Analysis of variance among the three groups using the one-way ANOVA 4. Discussion
test.
b
The results of the repeated measurement ANOVA test. So far, no study has evaluated the effects of foot reflexology on
bilirubin levels of neonates and as mentioned earlier, there is a paucity
the trial. However the defecation frequency was not significantly dif- of evidence in this regard. Hence, this study is novel. Our findings
ferent between the foot reflexology, sham reflexology, and control showed that newborns in the foot reflexology group had significantly
groups on the second, third, and fourth days after the intervention, it lower cutaneous bilirubin levels than those of the sham reflexology and
was significantly higher in the foot reflexology group than other two control groups on the first and third days after the intervention.
groups on the first day (P = 0.009) (Table 2). However, cutaneous bilirubin values did not differ between the three
groups on the fifth day. Also, except on the first day, defecation fre-
3.3. Intra- and inter- group comparisons of cutaneous bilirubin levels quencies showed no difference between all groups on the second to
fourth days after the intervention. The reduction of cutaneous bilirubin
The results of the One-way ANOVA test showed no statistically level in the foot reflexology group could be associated with the in-
significant difference at baseline in cutaneous bilirubin levels between creased defecation frequency, faster stool excretion, and thereby, re-
the three groups (P = 0.68). Inter-group comparisons through the One- duced enterohepatic circulation of bilirubin. Similarly, a published
way ANOVA test with the Tukey’s post hoc test illustrated that cuta- study revealed that frequent bowel movements diminished the en-
neous bilirubin levels at the two time point measurements, i.e. the first terohepatic circulation of bilirubin in a neonate [44]. Since each deci-
and third days after the intervention in the neonates of reflexology liter of meconium contains 1 mg/dl bilirubin; thus, the interventions
group was significantly less than those of the control and sham re- causing an increase in bowel movement and facilitating the excretion of
flexology groups (P < 0.001 and P = 0.003, respectively) Values of meconium in the first day of birth can prevent increase of bilirubin level
cutaneous bilirubin on the fifth day after the intervention in neonates of [3,6]. In our study, inter-group differences on defecation frequency and
foot reflexology group were similar to those in the sham reflexology and cutaneous bilirubin level can be attributed to the effects of foot re-
control groups (p = 0.07). Moreover, the results of the repeated mea- flexology. Several former studies have supported the positive effects of
surement ANOVA test showed a significant increase in mean cutaneous reflexology on increasing stool frequency. For instance, an earlier study
bilirubin levels from the baseline to the fifth day after the intervention showed that foot reflexology improved severity of constipation among
between three groups (P = 0.002, F = 6.95). Tukey's post hoc analysis children with cerebral palsy [36]. Another study found that six 30-min
indicated that mean levels of cutaneous bilirubin in the foot reflexology foot reflexology sessions had an improving effect on intestinal motility
group increased significantly less than the other two groups (Table 3). [31]. However, these studies have been performed in different age
groups and with various techniques, it was identified that because of
3.4. Comparison of dermal icterus at four time points similar mechanisms of action, reflexology had positive effects on the
defecation frequencies in neonates. The most important mechanism of
Dermal icterus did not appear in any of infants in three groups at the action for reflexology on body systems is explained by the autonomous
baseline and first day after the intervention. Although, on the third and nervous system. It is thought that applications to the sole affect body

Table 3
Comparison of cutaneous bilirubin levels (mg/dl) at four time points between three groups.
Time point Groups Test resultsa Test resultsb

Foot reflexology Sham reflexology Control

Mean (SD) Mean (SD) Mean (SD)

Baseline 2.78 ± 0.54 2.80 ± 0.79 2.62 ± 0.76 F = 0.38 F = 6.95

P = 0.68
First day 3.26 ± 0.49 4.00 ± 0.40 4.09 ± 0.32 F = 24.21
P < 0.001
Third day 10.14 ± 0.93 10.96 ± 1.21 11.32 ± 1.08 F = 4.14 df = 2
P = 0.003
Fifth day 10.08 ± 0.96 10.49 ± 1.20 10.94 ± 1.25 F = 2.84 P = 0.002
P = 0.07

a
The results of the one-way ANOVA test.
b
The results of the repeated measurement ANOVA test.

5
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

Table 4
Comparison of dermal icterus at third and fifth days after the intervention*.
Groups Time point The affected zone Test resultsa

No involvement Face and neck Upper trunk Total

Foot reflexology Third day 17 (85 %) 3 (15 %) 0 (0%) 20 (100 %) Third day
Fifth day 15 (75 %) 5 (25 %) 0 (0%) 20 (100 %) x2 =6.55
Sham reflexology Third day 12 (60 %) 6 (30 %) 2 (10 %) 20 (100 %) df =4
Fifth day 11 (55 %) 7 (35 %) 2 (10 %) 20 (100 %) p = 0.16
Control Third day 11 (55 %) 5 (25 %) 4 (20 %) 20 (100 %) Fifth day
Fifth day 10 (50 %) 8 (40 %) 2 (10 %) 20 (100 %) x2 = 3.87
df= 4
p = 0.49

* Data were presented as number frequency (percentage %).

a
The results of the Fisher exact test.

systems by increasing parasympathetic system activity. The influence of clinical management of jaundice, as well as future studies into reflex-
reflexology on the autonomic nervous system supports the ‘nerve ology therapy. This study has several strengths, including rigorous
theory’ [45]. So, application of pressure to certain points on the soles of single-blind randomized design with sham and control groups. None-
the feet can facilitate parasympathetic activity, increasing motility and theless, some limitations of this trial include short course of treatment
ultimately facilitating defecation [36]. Another mechanism for the and follow-up, no measuring of bilirubin level on all days after inter-
beneficial effects of reflexology is 'hemodynamic theory’, which claims vention, impossibility to measure the amount of feces excreted, and
that the instigation of a point in an area of the body can enhance blood limitation of findings generalizability to neonates with jaundice. Fur-
supply to the relevant organ [46]. In this regard, a preceding study into ther high quality RCT studies with larger sample size and inclusion of
the effects of foot reflexology on the intestine zone reported significant cost effectiveness as an important outcome are needed to elucidate the
increase in intestinal blood flow measured by color doppler sonography effects of reflexology on reducing hospital stay and readmissions and
[47]. We presumed that activation of the parasympathetic system and provide more robust evidence.
the increase of blood flow to the intestines due to stimulation of in-
testinal reflex points on the feet contributed to the increase of bowel 5. Conclusion
movement and thereby, leading to increased bilirubin excretion. Our
study also showed that early onset of foot reflexology immediately after This study found that foot reflexology had a promising effect on the
birth renders better outcomes, and level of bilirubin would begin its reduction of cutaneous bilirubin level, prevention of neonatal jaundice,
decreasing trend sooner. Nevertheless, no difference in cutaneous bi- and also reduction need for phototherapy. Therefore, nurses should
lirubin values between the three groups on fifth day may be due to the learn more about this procedure and its integration into routine neo-
fact that jaundice is a complex condition and is not solely the result of a natal care.
decrease in the enterohepatic circulation of bilirubin. In addition, not
ongoing the intervention for more days could have resulted to this Financial support
finding. A previous study indicated that massaging acupoints and in-
creasing the breastfeeding frequency were effective in reducing serum This study was financially supported by the Deputy of Research of
bilirubin levels of neonates with breast-feeding jaundice [48]. Although Gonabad University of Medical Sciences, Gonabad, Iran.
the result of this study is parallel to the present study on the first and
third days, the mentioned study examined the simultaneous effects of Declaration of competing interests
two interventions, i.e. acupoints massage and increased breastfeeding
frequency. In addition, type of procedure, tool for bilirubin measure- The authors declare that they have no conflicts of interest.
ment, and study population were different between two studies. Mas-
sage is the most common intervention that has been reported its effects Data availability
on neonatal jaundice. Some lines of studies have supported the positive
effects of massage on jaundice. But, a review of clinical trials showed Any additional information can be obtained from the corresponding
that current evidences are inconclusive to use the massage for the author on request.
management of jaundice in routine practice [49]. Both reflexology and
massage are among the manual treatments in complementary medicine CRediT authorship contribution statement
and act by moving the hands on the body to improve its function, but
reflexology applies pressure to certain reflex points [50] and appears to Mahdi Basiri Moghadam: Conceptualization, Methodology,
be more effective than massage. The research results also showed that Writing - review & editing, Writing - original draft, Supervision, Formal
although there was insignificant inter-groups difference respecting analysis. Mahboubeh Esmaeili: Resources, Writing - review & editing,
dermal icterus, neonates in the foot reflexology group had lower dermal Writing - original draft, Investigation, Project administration, Software.
icterus compared with their peers in other groups. No difference be- Shahla Khosravan: Writing - review & editing, Writing - original draft,
tween groups can be attributed to the fact that the clinical jaundice Methodology, Supervision, Validation. Seyyed Javad Mojtabavi:
develops in majority of infants on the first days of life. Also, factors such Methodology, Investigation, Visualization.
as different skin color and hemoglobin level of newborn may affect the
diagnosis of dermal icterus. The requirement for phototherapy was Acknowledgements
significantly lower in the foot reflexology group than the other two
groups. One reason for this decline could be due to positive effects of This study has been extracted from thesis of the corresponding au-
foot reflexology and the prevention of bilirubin rise. Foot reflexology thor in Gonabad University of Medical Sciences.We would like to thank
appears to be as a useful adjunct to reduce need for phototherapy. Gonabad University of Medical Sciences, all parents of newborns par-
Findings of this study can assist to providing a strong basis for the ticipated in this study and also Dr. Reza Gharaei for his help in selection

6
M. Basiri Moghadam, et al. European Journal of Integrative Medicine 38 (2020) 101173

of samples for the study. org/10.1155/2014/502123.

[25] N. Canbulat Sahiner, M. Demirgoz Bal, A randomized controlled trial examining the
effects of reflexology on children with functional constipation, Gastroenterol. Nurs.
Appendix A. Supplementary data 40 (5) (2017) 393–400, https://doi.org/10.1097/SGA.0000000000000196 (8).
[26] S. Icke, R. Genc, Effect of reflexology on Infantile colic, J. Altern. Complement.
Supplementary material related to this article can be found, in the Med. 24 (6) (2018) 584–588, https://doi.org/10.1089/acm.2017.0315.
[27] L. Hannula, P. Puukka, M. Asunmaa, M. Mäkijärvi, A pilot study of parents’ ex-
online version, at doi:https://doi.org/10.1016/j.eujim.2020.101173. periences of reflexology treatment for infants with colic in Finland, Scand. J. Caring
Sci. (2019), https://doi.org/10.1111/scs.12790.
References [28] N. Samadi, I. Allahyari, E. Mazaheri, M. Rostamnejad, N. Mehrnoush, M. Namadi,
et al., Effect of foot reflexology on physiologic index of neonates, IJN 5 (1) (2014)
19–22, https://doi.org/10.22038/IJN.2014.2352.
[1] R. Raeisi, S. Heidari-Soureshjani, M. Asadi-Samani, T. Luther, A systematic review [29] T. Koc, D. Gozen, The effect of foot reflexology on acute pain in infants: a rando-
of phytotherapies for newborn jaundice in Iran, Int. J. Pharm. Sci. Res. 8 (5) (2017) mized controlled trial, Worldviews Evid. Based Nurs. 12 (5) (2015) 289–296,
1953–1958, https://doi.org/10.13040/IJPSR.0975 8232.8(5).1953-1958. https://doi.org/10.1111/wvn.12099.
[2] C.H. Lin, H.C. Yang, C.S. Cheng, C.E. Yen, Effects of infant massage on jaundiced [30] R. Click, J. Dahl-Smith, L. Fowler, J. Dubose, M. Deneau-Saxton, J. Herbert, An
neonates undergoing phototherapy, Ital. J. Pediatr. 41 (1) (2015) 94, https://doi. osteopathic approach to reduction of readmissions for neonatal jaundice,
org/10.1186/s13052-015-0202-y. Osteopath. Fam. Physician 5 (1) (2013) 17–23, https://doi.org/10.1016/j.osfp.
[3] S. Karbandi, M. Lotfi, H. Boskabadi, H. Esmaily, The effects of field massage tech- 2012.09.005.
nique on bilirubin level and the number of defecations in preterm infants, Evid. [31] E. Bishope, E. Mckinone, E. Weir, D.W. Brown, Reflexology in the management of
Based Care J. 5 (4) (2016) 7–16, https://doi.org/10.22038/ebcj.2015.6057. encopresis and chronic constipation, Paediatr. Nurs. 15 (3) (2003) 20–22, https://
[4] M. Kianmehr, A. Moslem, K. Basiri Moghadam, M. Naghavi, S. Pasban Noghabi, doi.org/10.7748/paed2003.04.15.3.20.c843.
M. Basiri Moghadam, The effect of massage on serum bilirubin levels in term [32] M. Basiri Moghadam, S. Khosravan, S.J. Mojtabavi, M. Esmaeili, Effect of foot re-
neonates with hyperbilirubinemia undergoing phototherapy, Nautilus 128 (1) flexology on meconium passage in healthy infants, Complementary Medicine
(2014) 36–41. Journal 6 (2 (19)) (2016) 1521–1534 [Persian].
[5] M. Lei, T. Liu, Y. Li, Y. Liu, L. Meng, C. Jin, Effects of massage on newborn infants [33] A. Seyyedrasooli, L. Valizadeh, M.B. Hosseini, M. Asgari Jafarabadi,
with jaundice: a meta-analysis, Int. J. Nurs. Sci. 5 (1) (2018) 89–97, https://doi. M. Mohammadzad, Effect of vimala massage on physiological jaundice in infants: a
org/10.1016/j.ijnss.2018.01.004. randomized controlled trial, J. Caring Sci. 3 (3) (2014) 165–173, https://doi.org/
[6] H. Babaei, M. Vakiliamini, Effect of massage therapy on transcutaneous bilirubin 10.5681/jcs.2014.018.
level in healthy term neonates: randomized controlled clinical trial, IJN 9 (4) [34] M. Basiri Moghadam, K. Basiri Moghadam, M. Kianmehr, A. Jomezadeh,
(2018) 41–46 http://doi.org/0.22038/ijn.2018.28906.1386. F. Davoudi, Effects of massage on weight gain and jaundice in term neonates with
[7] F.A. Dzulkifli, M.Y. Mashor, K. Khalid, Methods for determining bilirubin level in hyperbilirubinemia, J. Isfahan Med. School 30 (183) (2012) 384–391 [Persian].
neonatal jaundice screening and monitoring: a literature review, J. Eng. Res. Educ. [35] J. Williamson, The Complete Guide to Precision Reflexology, Quay Books, a division
10 (2018) 1–10. of Mark Allen Publishing Ltd, 2nd revised edition, 2010 ISBN: 13 978-1-85642-
[8] R. Seyedi, M. Mirghafourvand, A. Jannat Dost, S. Mohammad-Alizadeh-Charandabi, 410-3.
M. Asghari Jafarabadi, Relationship between neonatal skin bilirubin level and se- [36] B. Elbasan, S. Bezgin, The effects of reflexology on constipation and motor functions
vere jaundice with maternal, childbirth, and neonatal characteristics, IJN 10 (2) in children with cerebral palsy, Pediatr. Neonatol. 59 (1) (2018) 42–47, https://doi.
(2019) 61–67, https://doi.org/10.22038/ijn.2019.33282.1478. org/10.1016/j.pedneo.2017.01.005.
[9] P. Woodgate, L.A. Jardine, Neonatal jaundice: phototherapy, BMJ Clin. Evid. (05) [37] T. Saeed, Validity of transcutaneous bilirubinometer in neonates as compared to
(2015) 0319 PMCID: 4440981. PMID: 25998618. laboratory serum bilirubin estimation, J. Rawalpindi Med. Coll. 17 (1) (2013)
[10] M.J. Maisels, A.F. McDonagh, Phototherapy for neonatal jaundice, N. Engl. J. Med. 81–83.
358 (2008) 920–928, https://doi.org/10.1056/NEJMct0708376. [38] M. Mahram, S. Oveisi, N. Jaberi, Trans-cutaneous bilirubinometery versus serum
[11] T. Xiong, G. Tang, D.Z. Mu, Side effects of phototherapy for neonatal heperbilir- bilirubin in neonatal jaundice, Acta Med. Iran. 53 (12) (2015) 764–769.
ubinemia, Chin. J. Contemp. Pediatr. 14 (5) (2012) 396–400 PMID: 22613117. [39] T. Waqar, Z. Ahmad, S. Ali, Comparison of serum bilirubin estimation with trans-
[12] A.C. Wickremasinghe, M.W. Kuzniewicz, B.A. Grimes, C.E. McCulloch, cutaneous bilirubinometry in neonates, Pak. Armed Forces Med. J. 60 (3) (2010)
T.B. Newman, Neonatal phototherapy and infantile cancer, Pediatrics 137 (6) 382–386.
(2016) e20151353, , https://doi.org/10.1542/peds.2015-1353. [40] M. Mansouri, A. Mahmoodnejad, R. Taghizadeh Sarvestani, F. Gharibi, A compar-
[13] N. Ramy, E.A. Ghany, W. Alsharany, A. Nada, R.K. Darwish, W.A. Rabie, et al., ison between transcutaneous bilirubin (cutaneous bilirubin) and total serum bilir-
Jaundice, phototherapy and DNA damage in full-term neonates, J. Perinatol. 36 (2) ubin (TSB) measurements in term neonates, Int. J. Pediatr. 3 (3.1) (2015) 633–641,
(2016) 132–136, https://doi.org/10.1038/jp.2015.166. https://doi.org/10.22038/ijp.2015.4352.
[14] M. Abdellatif, N.L. Vuong, G.M. Tawfik, M.K. Elfaituri, M.I.M. Mansour, M.M. Zaki, [41] T.S. Leung, K. Kapur, A. Guilliam, J. Okell, B. Lim, L.W. MacDonald, et al.,
et al., Massage therapy for the treatment of neonatal jaundice: a systematic review Screening neonatal jaundice based on the sclera color of the eye using digital
and network meta-analysis, J. Neonatal Nurs. 26 (1) (2020) 17–24, https://doi.org/ photography, Biomed. Opt. Express 6 (11) (2015) 4529–4538, https://doi.org/10.
10.1016/j.jnn.2019.09.002. 1364/BOE.6.004529.
[15] T.B. Newman, Y.W. Wu, M.W. Kuniewicz, B.A. Grimes, C.E. McCulloch, Childhood [42] P.M. Varughese, Kramer’s scale or transcutaneous bilirubinometry: the ideal choice
seizures after phototherapy, Pediatrics 142 (4) (2018) e20180648, , https://doi. of a pediatrician? Can we trust our eyes? Int. J. Contemp. Pediatr. 6 (5) (2019)
org/10.1542/peds.2018-0648. 1794, https://doi.org/10.18203/2349-3291.ijcp20193702.
[16] J. Chen, M. Sadakata, M. Ishida, N. Sekizuka, M. Sayama, Baby massage ameliorates [43] S.S. Tikmani, H.J. Warraich, F. Abbasi, A. Rizvi, G.L. Darmstadt, A.K.M. Ziadi,
neonatal jaundice in full-term newborn infants, Tohoku J. Exp. Med. 223 (2) (2011) Incidence of neonatal hyperbilirubinemia: a population-based prospective study in
97–102, https://doi.org/10.1620/tjem.223.97. Pakistan, Trop. Med. Int. Health 15 (5) (2010) 502–507, https://doi.org/10.1111/j.
[17] S. Ullah, K. Rahman, M. Hedayati, Hyperbilirubinemia in neonates: types, causes, 1365-3156.2010.02496.x.
clinical examinations, preventive measures and treatments: a narrative review ar- [44] B.A. Semmekrot, G.P. Gerrits, Optimal breastfeeding to prevent hyperbilir-
ticle, Iran J Public Health 45 (5) (2016) 558–568 PMCID: PMC4935699. PMID: ubinaemia in healthy, term newborns, Ned. Tijdschr. Geneeskd. 148 (41) (2004)
27398328. 2016–2019.
[18] K.S. Najib, F. Saki, F. Hemmati, S. Inaloo, Incidence, risk factors and causes of [45] C.M. Hughes, S. Krirsnakriengkrai, S. Kumar, S.M. McDonough, The effect of re-
severe neonatal hyperbilirubinemia in the South of Iran (Fars Province), Iran. Red flexology on the autonomic nervous system in healthy adults: a feasibility study,
Crescent Med. J. 15 (3) (2013) 260–263, https://doi.org/10.5812/ircmj.3337. Altern. Ther. Health Med. 17 (2011) 32e7.
[19] B.S. Bilgin, O.A. Koroglu, M. Yalaz, S. Karaman, N. Kultursay, Factors affecting [46] E. Ingham, Stories the Feet Can Tell Thru Reflexology, Stories the Feet Have Told
bilirubin levels during first 48 hours of life in healthy infants, BioMed Res. Int. 2013 Thru Reflexology, Ingham Publishing, St Petersburg, Fla, USA, 1984.
(2013), https://doi.org/10.1155/2013/316430. [47] E. Mur, J. Schmidseder, I. Egger, G. Bodner, G. Eibl, F. Hartig, K.P. Pfeiffer,
[20] A. Mohammadzadeh, A.S. Farhat, A. Ghasemian, M. Ramezani, H.A. Esmaily, M. Herold, Influence of reflex zone therapy of the feet on intestinal blood flow
B.M. Musavi, Effects of oral zinc sulfate on hyperbilirubinemia in low-birth-weight measured by color Doppler sonography, Forsch. Komplementarmed. Kl.
neonates, IJN 7 (2) (2016) 11–15, https://doi.org/10.22038/ijn.2016.7107. Naturheilkd 8 (2) (2001) 86–89, https://doi.org/10.1159/000057201.
[21] M. Butler-O’Hara, A. Reininger, H. Wang, S.B. Amin, N.J. Rodgers, C.T. D’Angio, A [48] Q. Xuelan, Y. Qingling, S. Changhong, et al., Effect of acupoint massage and breast-
randomized controlled trial of glycerin suppositories during phototherapy in pre- feeding frequency on serum bilirubin levels of neonates with breast-feeding jaun-
mature neonates, J. Obstet. Gynecol. Neonatal Nurs. 46 (2) (2017) 220–228, dice, Journal of Qilu Nursing 14 (8) (2005) 28–32 [Chinese].
https://doi.org/10.1016/j.jogn.2016.10.008. [49] B.D. Garg, N.S. Kabra, H. Balasubramanian, Role of massage therapy on reduction
[22] A. White, J. Williamson, A. Hart, E. Ernst, A blinded investigation into the accuracy of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical
of reflexology charts, Complement. Ther. Med. 8 (3) (2000) 166–172. trials, J. Matern. Neonatal Med. 32 (2) (2019) 301–309, https://doi.org/10.1080/
[23] A. Lett, The future of reflexology, Complement. Ther. Nurs. Midwifery 8 (2) (2002) 14767058.2017.1376316.
84–90, https://doi.org/10.1054/ctnm.2001.0581. [50] D. Tiran, H. Chummun, The physiological basis of reflexology and its use as a po-
[24] J.E.M. McCullough, S.D. Liddle, M. Sinclair, C. Close, C.M. Hughes, The physiolo- tential diagnostic tool, Complement. Ther. Clin. Pract. 11 (1) (2005) 58–64, https://
gical and biochemical outcomes associated with a reflexology treatment: a sys- doi.org/10.1016/j.ctnm.2004.07.007.
tematic review, Evid. Based Complement. Altern. Med. 2014 (2014), https://doi.