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
1 other identifier
interventional
105
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2026
CompletedStudy Start
First participant enrolled
May 9, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2027
May 28, 2026
May 1, 2026
10 months
May 8, 2026
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Heart rate
Immediately before and immediately after each phototherapy session.
Respiratory Rate
Immediately before and immediately after each phototherapy session.
Oxygen Saturation
Immediately before and immediately after each phototherapy session.
Body Temperature
Immediately before and immediately after each phototherapy session.
Neonatal Stress Level
Immediately before and immediately after each phototherapy/intervention session.
Study Arms (3)
Foot Reflexology Group
EXPERIMENTALNeonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions.
Body Massage Group
EXPERIMENTALNeonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions.
Control Group
ACTIVE COMPARATORNeonates in this group will receive standard phototherapy care only without any additional intervention.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kuşadası State Hospital
Aydin, Kuşadası, 09400, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ayten taspinar, Professor
Aydin Adnan Menderes University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 28, 2026
Study Start
May 9, 2026
Primary Completion (Estimated)
March 8, 2027
Study Completion (Estimated)
May 8, 2027
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.