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

The Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Newborns; Crying
• Intervention / Treatment: Behavioral: Kangaroo Care; Behavioral: Swaddling

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bucak
    • Burdur, Bucak, Turkey, 15030
      • Burdur Bucak State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In this group, infants received routine heel blood collection procedure.
Experimental: Kangaroo Care Group; 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; Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken.
Experimental: Swaddling Group; Heel blood will be taken while the infant was swaddled in the maternal holding.	Behavioral: Swaddling; Heel blood will be taken while the infant was swaddled in the maternal holding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying times	Duration of crying were recorded.	during the heel blood collection procedures
Processing time	Duration of heel blood collection procedure were recorded.	during the heel blood collection procedures

Collaborators and Investigators

• Sponsor: Burdur Mehmet Akif Ersoy University
• Investigators: Study Director: Emine Geçkil, Professor, Necmettin Erbakan University; Principal Investigator: Selda Ateş Beşirik, PhD., Burdur Mehmet Akif Ersoy University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Newborn; Swaddling; Heel stick; Crying time; Kangaroo care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 2023/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No