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NCT07610811
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Conditions: Neonatal Hyperbilirubinemia
Sex: All
Ages: 2 Days – 10 Days
Healthy volunteers: No
Phase: NA
Enrollment: 105
Sponsor: Aydin Adnan Menderes University
Location: Kuşadası State Hospital Kusadasi Aydın
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 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
Source: ClinicalTrials.gov (NCT07610811). StuddyBuddy aggregates publicly available trial information.