An interventional study of Foot Reflexology and Body Massage in Neonatal Hyperbilirubinemia, sponsored by Aydin Adnan Menderes University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 10 Days. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care
Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns.
This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy.
A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention.
The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.
Neonatal hyperbilirubinemia is one of the most common conditions requiring hospitalization in the early neonatal period. Although phototherapy is the standard treatment, it may be associated with potential short- and long-term adverse effects, including dehydration, thermoregulation disturbances, and increased stress responses. Therefore, there is growing interest in complementary, non-invasive interventions that may enhance treatment effectiveness and improve neonatal outcomes.
Massage therapy and foot reflexology are commonly used complementary interventions in neonatal care. These interventions are thought to stimulate the gastrointestinal system, increase bowel movements, and facilitate bilirubin excretion. In addition, they may contribute to improved physiological stability and reduced stress levels through tactile stimulation.
This study is designed as a randomized controlled trial to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters, and stress levels in neonates receiving phototherapy. Physiological parameters include heart rate, respiratory rate, oxygen saturation, and body temperature.
The study will be conducted in a neonatal intensive care unit and will include 105 neonates diagnosed with indirect hyperbilirubinemia. Participants will be randomly assigned to one of three groups: foot reflexology group, body massage group, and control group. Interventions will be administered prior to phototherapy sessions.
Data will be collected using standardized tools, including a Neonatal Information Form, Neonatal Follow-up Form, and a validated Neonatal Stress Scale. Outcome measures will be assessed before and after the interventions.
The findings of this study are expected to provide evidence on the effectiveness of complementary non-pharmacological interventions in reducing bilirubin levels, improving physiological stability, and decreasing stress in neonates. These results may contribute to the integration of evidence-based complementary practices into neonatal care.
96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's planned enrollment of 105 is close to the median of 100 across 61 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions.
Behavioral: Foot Reflexology
Neonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions.
Behavioral: Body Massage
Neonates in this group will receive standard phototherapy care only without any additional intervention.
Device: Phototherapy Device
Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Phototherapy will be provided using a standard phototherapy device according to the neonatal intensive care unit's routine clinical protocol for the management of neonatal indirect hyperbilirubinemia.
Total Serum Bilirubin Level
Total serum bilirubin level will be measured to evaluate the effect of foot reflexology and body massage on bilirubin reduction in neonates receiving phototherapy.
Time frame: Immediately before and immediately after each phototherapy session.
Heart rate
Heart rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as beats per minute.
Time frame: Immediately before and immediately after each phototherapy session.
Respiratory Rate
Respiratory rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as breaths per minute.
Time frame: Immediately before and immediately after each phototherapy session.
Oxygen Saturation
Oxygen saturation will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as percentage oxygen saturation.
Time frame: Immediately before and immediately after each phototherapy session.
Body Temperature
Body temperature will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported in degrees Celsius.
Time frame: Immediately before and immediately after each phototherapy session.
Neonatal Stress Level
Neonatal stress level will be evaluated using the Newborn Stress Scale developed by Ceylan and Bolışık. This observational scale includes eight domains: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each domain reflects observable behavioral or physiological stress responses in the newborn, such as changes in facial expression, skin color, breathing pattern, motor activity, ability to be consoled, muscle tension, limb movements, and body posture. Items are scored from 0 to 2, with higher scores indicating a higher level of neonatal stress. The outcome will be reported as the total scale score.
Time frame: Immediately before and immediately after each phototherapy/intervention session.
Plan to share: No — Individual participant data will not be shared due to ethical and privacy considerations involving neonatal participants. Aggregated study findings may be shared through scientific publications and presentations.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2027, 9 months after the start.
Of 34 non-industry interventional studies with no phase under Hyperbilirubinemia, Neonatal, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 9 months is close to that.
Counting every sponsor, half of 34 studies reached it within 10 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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