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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy

NCT07761689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Procedural Pain
  • Neonatal Hyperbilirubinemia

Interventions

BEHAVIORAL

Kangaroo Care

In this study, kangaroo care is applied as the intervention. Kangaroo care is defined as placing the newborn, wearing only a diaper, in a prone and upright position on the bare chest of the mother (or caregiver), with the infant's back covered with a blanket to prevent heat loss. The intervention is applied during the heel-prick blood sampling procedure in newborns receiving phototherapy, beginning a specified period before the procedure and continuing throughout the procedure. The duration of kangaroo care and the application conditions are standardized for all participants, and no additional analgesic or pharmacological interventions are administered during the intervention.

BEHAVIORAL

Routine Care

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Ebru UYGUR, MSc(student) · Marmara University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-30
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761689 on ClinicalTrials.gov