Foot Reflexology and Massage in Neonates Receiving Phototherapy

Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: Behavioral: Foot Reflexology; Behavioral: Body Massage; Device: Phototherapy Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yagmur karadas, PhD; Phone Number: +905072209435; Email: yagmurerisen@gmail.com
• Study Contact Backup: Name: ayten taspinar, Professor; Phone Number: +905362581624; Email: ayten.taspinar@adu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kuşadası
    • Aydin, Kuşadası, Turkey (Türkiye), 09400
      • Kuşadası State Hospital
      • Contact: yağmur erişen; Phone Number: 05072209435; Email: yagmurerisen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Neonates whose parents/legal guardians have signed the informed consent form and agreed to participate in the study
• Neonates born between 34 and 41 weeks of gestation
• Birth weight of 2500 g or above
• Not mechanically ventilated
• No nasogastric tube
• Stable vital signs
• No elevated acute phase reactants during phototherapy treatment
• Indirect bilirubin level between 12 and 28 mg/dL at admission to the neonatal intensive care unit
• Not receiving antibiotic treatment during the study
• Aged between 2 and 10 days
• No health problems other than indirect hyperbilirubinemia.

Exclusion Criteria:

• Presence of any neurological anomaly
• Presence of any congenital anomaly
• Jaundice due to ABO incompatibility
• Jaundice due to Rh incompatibility
• Presence of dermal anomalies
• Diagnosis of hyperbilirubinemia within the first 24 hours after birth
• Diagnosis of direct hyperbilirubinemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foot Reflexology Group; Neonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions.	Behavioral: Foot Reflexology; Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Experimental: Body Massage Group; Neonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions.	Behavioral: Body Massage; Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Active Comparator: Control Group; Neonates in this group will receive standard phototherapy care only without any additional intervention.	Device: Phototherapy Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before and immediately after each phototherapy session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as beats per minute.	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.	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.	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.	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.	Immediately before and immediately after each phototherapy/intervention session.

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Chair: ayten taspinar, Professor, Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Estimated): May 9, 2026
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): May 8, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neonate; Phototherapy; Hyperbilirubinemia; Bilirubin; Complementary Therapy; Physiological Parameters; Foot Reflexology; Non-pharmacological Intervention; Neonatal Massage; Neonatal Stress
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
• Other Study ID Numbers: 2025/008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No