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

NCT06350071 | Completed

• 1 other identifier: 2023/06
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Newborns; Crying

Keywords

Newborn; Pain; Crying time; Kangaroo care; Swaddling; Heel stick

Outcome Measures

Primary Outcomes (1)

• NIPS (Neonatal Infant Pain Scale)

  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.

  during the heel blood collection procedures

Secondary Outcomes (2)

• Crying times

  during the heel blood collection procedures

• Processing time

  during the heel blood collection procedures

Study Arms (3)

Kangaroo Care Group

EXPERIMENTAL

Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken.

Behavioral: Kangaroo Care

Swaddling Group

EXPERIMENTAL

Heel blood will be taken while the infant was swaddled in the maternal holding.

Behavioral: Swaddling

Control Group

NO INTERVENTION

In this group, infants received routine heel blood collection procedure.

Interventions

Kangaroo Care BEHAVIORAL

Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken.

Kangaroo Care Group

Swaddling BEHAVIORAL

Heel blood will be taken while the infant was swaddled in the maternal holding.

Swaddling Group

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Bucak State Hospital

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Crying; Pain

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

• Emine Geçkil, Professor

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: June 19, 2023
• Primary Completion: December 15, 2024
• Study Completion: March 14, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)