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

NCT07580677 | Completed DMC

• 1 other identifier: CU-SBF-BSB-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Comfort in Neonates; Kangaroo Care; Breast-feeding; Pain in Newborns

Keywords

Kangaroo Care; Breastfeeding; Comfort of The Newborn; Pain of The Newborn

Outcome Measures

Primary Outcomes (1)

• Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature.

  Newborn Infant Pain Scale Assessment Form: The NIPS Form is used to assess pain and consists of six behavioral responses: facial expression, emission pattern, arms, fullness, and volume. Crying performance is given three points (0-1-2), while other behaviors are given only two points (0-1). The total score is calculated based on the Neonatal Pain Scale, with a maximum score of 7 and a minimum score of 0. A NIPS score between 0-2 indicates no pain and requires no intervention. A pain score between 3-4 indicates moderate acoustic pain, and complementary and alternative interventions are applied. A pain score above four suggests complementary and alternative Neonatal Comfort Behavior Scale (NICS): Each item on the scale is scored from 1 to 5. The overall score is used for evaluation. The lowest possible score on the Newborn Comfort Behavior Scale is 6, and the highest is 30. A total score between 9-13 indicates that the baby is comfortable, while a score between 14-30 indicates that th

  about a year

Study Arms (3)

This is the group where the baby is breastfed before the heel prick blood test. In this group, the e

EXPERIMENTAL

Breastfeeding Group (Group 1) Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated before, during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test.

Other: breastfeeding

This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab

EXPERIMENTAL

Kangaroo Care Group (Group 2) Each baby in the group will be given 30 minutes of kangaroo care before heel prick blood is taken. Physiological parameters, NIPS (Neural Network Imaging System) scores, and comfort behavior will be evaluated before, during, and after the procedure.

Other: Kangaroo Care

This is the group that receives standard care.

EXPERIMENTAL

Control Group (Group 3) Physiological parameters, NIPS (Neuroprocedure Testing System), and comfort behavior will be evaluated before, during, and after the procedure.

Other: Standard Care (in control arm)

Interventions

breastfeeding OTHER

Before the heel prick blood test, a newborn information form and a parent identification form will be completed. Parents will be given information about breastfeeding, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be breastfed for 15-30 minutes before the heel prick blood test. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the heel prick blood test. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.

This is the group where the baby is breastfed before the heel prick blood test. In this group, the e

Kangaroo Care OTHER

Before the procedure, a newborn information form and a parent identification form will be completed. Parents will be given information about kangaroo care, and physiological parameters, NIPS (Neural Network Indicators), and comfort behavior will be evaluated before the procedure. Each baby in the group will be provided with kangaroo care for 30 minutes before the heel prick blood sample is taken. Physiological parameters, NIPS, and comfort behavior will be evaluated during and after the procedure. In addition, the duration of the newborn's crying will be recorded with a stopwatch during the procedure. The newborn will be recorded with a camera during the procedure for evaluation by the blind evaluator.

This group receives skin-to-skin contact (kangaroo care) before the heel prick blood test on the bab

Standard Care (in control arm) OTHER

No intervention will be performed. Routine hospital procedure will be applied.Physiological parameters, NIPS (Neuro-Visual Imaging System), and comfort behavior will be evaluated before, during, and after the procedure. Additionally, the newborn's crying duration will be recorded using a stopwatch during the procedure. The newborn will also be recorded on camera during the procedure for evaluation by a blind evaluator.

This is the group that receives standard care.

Eligibility Criteria

• Age: 24 Hours - 1 Day
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parental consent must be obtained in accordance with the participant information and consent form
• The baby must be term, between 37-42 weeks gestation
• Birth weight must be 2500 grams or more
• The mother must be present with the baby
• The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed)
• There must be no condition that prevents pain assessment (neuromotor developmental delay, etc.)
• The baby must not have undergone any invasive procedures other than routine interventions
• The baby must have been born by cesarean section
• The mother must speak and understand Turkish fluently

You may not qualify if:

• Pre-procedure NIPS score of 3 or higher
• Lack of parental consent based on participant information and consent form
• Newborn born before 37 weeks of gestation
• Birth weight under 2500 grams
• Unstable general condition
• Vaginal delivery
• Invasive procedures performed on the baby other than routine procedures
• Failure to obtain heel prick blood on the first attempt
• Mother not speaking Turkish

Sponsors & Collaborators

• Cumhuriyet University: lead
• Cumhuriyet University Hospital: collaborator

Study Sites (1)

Sivas Cumhuriyet Üniversitesi Sağlık Hizmetleri Uygulama ve Araştırma Hastanesinde Kadın Hastalıkları Obs-tetri servisi

Sivas, Merkez, 58030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Lactation; Kangaroo-Mother Care Method; Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• FERDAĞ YILDIRIM

  SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK HİZMETLERİ MESLEK YÜKSEKOKULU

  STUDY DIRECTOR

• EMİNE ALTUN YILMAZ

  SİVAS CUMHURİYET ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ HEMŞİRELİK BÖLÜMÜ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study group consisted of newborn babies, one of the observers who scored the pain and comfort was an independent person from the research, and the observer made the evaluation without knowing which group the babies belonged to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: May 12, 2026
• Study Start: February 20, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)