Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection

Not Applicable

Completed

• Conditions: Pain, Acute; Crying; Newborns
• Interventions: Behavioral: Swaddling; Behavioral: Kangaroo Care

• Registration Number: NCT06350071
• Lead Sponsor: Burdur Mehmet Akif Ersoy University

Brief Summary

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.

Detailed Description

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.

This study is a prospective, randomized and controlled trial. In this study aim, the effect of kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined.

Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40).

Data were collected using the Infant-family Information Form, NIPS - Neonatal Infant Pain Scale, and Crying Follow-up Form.

Study Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Primary Completion: 2024-12-15
• Status Verified: 2025-03
• Study Completion: 2025-03-14
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Parents who volunteered and gave consent to participate in the research
• Full term neonates (38-42 weeks of gestation)
• Underwent heel stick blood drawing for routine metabolic screening,
• Aged 1 to 4 days
• Passed the hearing screening
• Birth weight between 2500-4400 grams
• Parents who know how to read, write and speak Turkish.

Exclusion Criteria

• Parents with any mental problems
• Infants with any chronic disease and congenital anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swaddling Group	Swaddling	Heel blood will be taken while the infant was swaddled in the maternal holding.
Kangaroo Care Group	Kangaroo Care	Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken.

Primary Outcome Measures

Name	Time	Method
NIPS (Neonatal Infant Pain Scale)	during the heel blood collection procedures	It was developed to evaluate interventional pain in newborns. Its Turkish adaptation was in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.

Secondary Outcome Measures

Name	Time	Method
Crying times	during the heel blood collection procedures	Duration of crying were recorded.
Processing time	during the heel blood collection procedures	Duration of heel blood collection procedure were recorded.

Trial Locations

Locations (1)

Burdur Bucak State Hospital; 🇹🇷 Burdur, Bucak, Turkey