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NCT Number: NCT06350071

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Behavior Communication Crying Neurologic Manifestations Newborns Nonverbal Communication Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burdur Bucak State Hospital

Burdur, Bucak, 15030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Swaddling

Behavioral

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

Primary outcomes

  1. NIPS (Neonatal Infant Pain Scale)

    Time frame: during the heel blood collection procedures

    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.

Secondary outcomes

  1. Crying times

    Time frame: during the heel blood collection procedures

    Duration of crying were recorded.

  2. Processing time

    Time frame: during the heel blood collection procedures

    Duration of heel blood collection procedure were recorded.

Sponsors and collaborators

Lead sponsor

Burdur Mehmet Akif Ersoy University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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