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RECRUITING Not applicable ClinicalTrials.gov

Foot Reflexology and Massage in Neonates Receiving Phototherapy

Sponsor: Aydin Adnan Menderes University • ClinicalTrials.gov ID: NCT07610811

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Foot Reflexology (Behavioral)
    Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
  • Body Massage (Behavioral)
    Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
  • Phototherapy Device (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.

Eligibility criteria

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

Conditions

Neonatal Hyperbilirubinemia

Locations

  • Kuşadası State Hospital — Kusadasi, Aydın, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record