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Clinical Trials in Turkey / NCT07610811
Recruiting Not applicable

Foot Reflexology and Massage in Neonates Receiving Phototherapy

NCT07610811 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-05-09
Last updated
2026-09-25

Condition(s) studied

Neonatal Hyperbilirubinemia

Investigational drug(s) / intervention(s)

Foot ReflexologyBody MassagePhototherapy Device

Foot Reflexology: Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.

Body Massage: Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.

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.

Study 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.

Eligibility

Sex
ALL
Min age
2 Days
Max age
10 Days
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kuşadası State Hospital Kusadasi Aydın Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07610811 on ClinicalTrials.gov ↗ ← All trials in Turkey