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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy

ConditionsProcedural PainNeonatal Hyperbilirubinemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorMarmara University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kangaroo Care

    Behavioral

    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.

  • Routine Care

    Behavioral

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Mother Kangaroo CareExperimental treatment 1 intervention
Group B: Nurse Kangaroo CareExperimental treatment 1 intervention
Group C: Standart Care (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hearth rate

hearth rate of the infant in 1 minutes

Time frame
30 minutes
2

respiratory rate

respiratory rate of the infant in 1 minutes

Time frame
30 minutes
3

O2 saturation

O2 saturation of the infant

Time frame
30 minutes
4

body temperature

body temperature of the infant

Time frame
30 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Source ClinicalTrials.gov
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