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

B

Burdur Mehmet Akif Ersoy University

Status

Completed

Conditions

Newborns
Crying
Pain, Acute

Treatments

Behavioral: Swaddling
Behavioral: Kangaroo Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06350071
2023/06

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

1 to 4 days old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Selda Ateş Beşirik, PhD.

Data sourced from clinicaltrials.gov

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