Foot reflexology and massage for newborns receiving light therapy
Official title: Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial
Run by Aydin Adnan Menderes University · NCT07610811 · Data updated 2026-11-12
This trial tests whether foot reflexology or body massage, added to standard phototherapy, can help lower bilirubin levels and improve stability in newborns with indirect hyperbilirubinemia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Days to 10 Days |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 1 site (Kusadasi, Aydın) |
| Status | Recruiting |
| Started | May 9, 2026 |
| Main results expected | March 8, 2027 |
| Study ends | May 8, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07610811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 2–10 days old, 34–41 weeks gestation, birth weight ≥2500 g, with indirect bilirubin 12–28 mg/dL, not on antibiotics, and stable vitals.
✕Probably not a fit
Newborns outside the inclusion criteria or with direct hyperbilirubinemia, significant medical complications, or those receiving mechanical ventilation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized trial, 105 newborns with indirect hyperbilirubinemia in a neonatal intensive care unit are assigned to foot reflexology, body massage, or a control group before phototherapy. The study measures total serum bilirubin and physiological parameters (heart rate, respiratory rate, oxygen saturation, temperature) as well as stress levels before and after the intervention. Interventions are non-pharmacological and bedside-based, aiming to complement standard phototherapy. The trial seeks to determine if tactile therapies can enhance bilirubin clearance and neonatal stability during treatment.
Why it matters
Potential benefit: If successful, these non-invasive approaches could reduce bilirubin levels and improve physiological stability for newborns undergoing phototherapy.
How similar studies have gone: Previous studies have explored non-pharmacological methods in neonatal care, but results on bilirubin reduction are mixed and this approach remains relatively novel in this specific setting.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Kuşadası State Hospital
Kusadasi, Aydın, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: yagmur karadas, PhD
- Email: yagmurerisen@gmail.com
- Phone: +905072209435
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Kangaroo Care by Mother or Nurse to Reduce Pain During Phototherapy in Newborns
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This trial will test whether adding a bedside exhaled-carbon monoxide (ETCOc) measurement to a modified diagnosis and treatment plan can help prevent brain damage in newborns with severe hyperbilirubinemia.
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High-intensity and cycled phototherapy for newborn jaundice
This test compares higher-intensity and intermittent (cycled) phototherapy to standard continuous light to see which lowers bilirubin faster in newborns born at or after 33 weeks with non-hemolytic jaundice.
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Determining safe levels to stop phototherapy for newborn jaundice
This study is testing if stopping light treatment for jaundice in newborns at a lower level is safer and helps prevent a return of high bilirubin levels compared to stopping at a higher level.
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Ursodeoxycholic acid plus continuous triple phototherapy for newborn indirect jaundice
This trial will test whether adding oral ursodeoxycholic acid to continuous triple phototherapy helps newborns (≥34 weeks) with indirect hyperbilirubinemia lower bilirubin faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.