Kangaroo Care by Mother or Nurse to Reduce Pain During Phototherapy in Newborns
Official title: The Effect of Two Different Kangaroo Care Interventions on Pain Level During Heel Prick Procedure in Neonates Receiving Phototherapy: A Randomized Controlled Trial
Run by Marmara University · NCT07761689 · Data updated 2026-11-12
This study tests whether mother-administered or nurse-administered kangaroo care during a heel-stick procedure reduces pain in newborns with hyperbilirubinemia, compared with standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Days to 7 Days |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07761689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newborns 38 weeks or more gestational age with physiological hyperbilirubinemia (bilirubin 13–18 mg/dL), 2–7 days old, whose mothers can participate and speak Turkish.
✕Probably not a fit
Newborns with conditions other than physiological jaundice, or those not meeting the inclusion criteria, may not experience a benefit from kangaroo care in this specific setting.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial randomizes newborns with physiological jaundice to three groups: mother-provided kangaroo care, nurse-provided kangaroo care, or routine care during a mandatory heel-stick blood draw. It aims to compare pain outcomes across provider models of kangaroo care in the setting of phototherapy. Kangaroo care is performed skin-to-skin with the infant in a diaper, and the study seeks to determine which model most effectively lowers procedural pain. The investigation contributes data on whether trained nurses can reliably substitute for mothers in delivering nonpharmacologic analgesia in neonates. The study is conducted at Başakşehir Çam and Sakura City Hospital with Marmara University as the lead sponsor.
Why it matters
Potential benefit: If successful, the findings could inform neonatal pain management protocols by validating nurse-provided kangaroo care as an effective alternative when mothers are unavailable.
How similar studies have gone: Previous evidence supports kangaroo care for reducing neonatal pain, but direct comparisons of provider models (mother vs. nurse) are limited, making this study relatively novel in its approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary participation of the mother * Gestational age of 38 weeks or more * Diagnosis of physiological hyperbilirubinemia only * Serum bilirubin level within the moderate-high range (13-18 mg/dL) according to the Turkish Neonatal Society Guideline for the Management, Follow-up, and Treatment of Neonatal Jaundice (2022 update) * Postnatal age between 2 and 7 days * Absence of any condition preventing the infant from feeding * Absence of any maternal health condition that would preclude the application of kangaroo care * Ability of the mother to speak Turkish and to understand the information provided about the study Exclusion Criteria: * Gestational age less than 34 weeks or 38 weeks and above * Diagnosis of sepsis or any other systemic infection * Presence of congenital anomalies * Diagnosis of pathological jaundice * Use of antibiotic therapy * Serum bilirubin level greater than 18 mg/dL * Postnatal age greater than 7 days * Mother's refusal to participate in the study
Where it's running
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Başakşehir Çam and Sakura City Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Ebru UYGUR, MSc(student) — Marmara University
- Study coordinator: Ebru UYGUR, MSc
- Email: ebruygurr@gmail.com
- Phone: 05336822564
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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.