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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350071
• Other study ID #: 2023/06
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Burdur Mehmet Akif Ersoy University
• Contact: Selda Ates Besirik, PhD.
• Phone: +905076228189
• Email: seldaates07[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 4 Days

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Crying
• Newborns
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
Turkey	Burdur Bucak State Hospital	Burdur	Bucak

Sponsors (1)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Crying times	Duration of crying were recorded.	during the heel blood collection procedures
Secondary	Processing time	Duration of heel blood collection procedure were recorded.	during the heel blood collection procedures