Clinical Trial

The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort

Completed
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Summary
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to. Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain. H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain. H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level. H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level. H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level. H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level. The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026. The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns. The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.
Trial Details
NCT Number NCT07580677
Lead Sponsor Cumhuriyet University
Collaborators: Cumhuriyet University Hospital
Conditions Comfort in Neonates, Kangaroo Care, Breast-feeding, Pain in Newborns
Enrollment 120 participants
Start Date 2025-02-20
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12