Transient Familial Hyperbilirubinemia Clinical Trials

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The Effect of Two Different Kangaroo Care Interventions on Pain Level During Heel Prick Procedure in Neonates Receiving Phototherapy: A Randomized Controlled Trial

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 2 days

Maximum Age: 7 days

Healthy Volunteers: t

View:

• 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

Locations

Other Locations

Turkey

Başakşehir Çam and Sakura City Hospital

RECRUITING

Istanbul

Contact Information

Primary

Ebru UYGUR, MSc

ebruygurr@gmail.com

05336822564

Backup

Çağrı ÇÖVENER ÖZÇELİK, PhD

ccovener@gmail.com

Time Frame

Start Date: 2026-06-01

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 45

Treatments

Experimental: Mother Kangaroo Care

Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the mother's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher after reviewing the video recordings.

Experimental: Nurse Kangaroo Care

Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the researcher's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.

Active_comparator: Standart Care (Control)

Infants in this group will undergo the heel-stick procedure in a standard position inside the incubator in accordance with hospital routine, and kangaroo care will not be applied. Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.

Related Therapeutic Areas

Transient Familial Hyperbilirubinemia

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