Clinical trial NCT06350071: Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Newborns
Crying
Keywords: Newborn
Pain
Crying time
Kangaroo care
Swaddling
Heel stick
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NIPS (Neonatal Infant Pain Scale)
timeFrame: during the heel blood collection procedures
Secondary outcomes:
measure: Crying times
timeFrame: during the heel blood collection procedures
measure: Processing time
timeFrame: during the heel blood collection procedures
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Bucak State Hospital
state: Bucak
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Emine Geçkil, Professor
role: STUDY_DIRECTOR
References: