Effects of Three Different Methods in Reducing Pain During Heel Blood Collection

Not Applicable

Recruiting

• Conditions: Newborn; Pain Management; Breastfeeding; Vibration; Wounds, Penetrating; Needlestick Injuries

• Registration Number: NCT06741670
• Lead Sponsor: Burdur Mehmet Akif Ersoy University

Brief Summary

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration on pain levels during heel blood collection on healthy term newborn's.

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 Breastfeeding, Vibration, and Breastfeeding+Vibration during heel blood collection on the pain levels in healthy term newborn's will be examined.

Sample of the study consisted of a total of 200 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into four groups; Breastfeeding group (n=50), Vibration group (n=50), Breastfeeding+Vibration group (n=50), and Control group (n=50).

Data were collected using the Infant-family Information Form and NIPS-Neonatal Infant Pain Scale. Data collection All blood sampling was performed in a quiet nursery room between 09:00 AM and 11:00 AM, 1-2 hours after breastfeeding, the normal time when infants undergo heel stick for routine blood collection for metabolic screening. Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years' experience in the performance heel stick and had no conflict of interest. A pediatrician made the clinical decision for heel stick.

Before the procedure, the newborns were kept in a quiet room far away from the cries of other babies. The infants' diapers were changed before procedure. For the heel stick procedure, the antiseptic solution (70% alcohol), heel stick method, heel region for sampling (the outer right side of the ball), needle (21-G needle), and environmental factors such as heat, light, and noise were all standardized. The whole procedure was video-recorded until three minutes after the procedure.

At the beginning of the study, the parents of the newborns were informed about the aim and content of the research, and parental approval was obtained. Neonatal and family demographics were collected using self-report information forms, which included medical history, mother's gestational age, neonatal age, sex, birth weight, duration of sampling, total crying time, processing time, and the time from the start of the first cry to the first crying during the process.

All blood sampling in the study was performed for clinical purposes, such as newborn metabolic screening tests, which were taken on the second to third days following birth. The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant, lancing the heel, and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected.

All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure. After the procedure the newborns' pain levels and crying duration were evaluated using the video recordings. Assessment of pain was conducted independently by the investigator and the nurse using NIPS. At the same time, the newborns' total procedural crying time, the duration of the procedure, and the first calming time were recorded. The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying. The time of the procedure was measured from the beginning to the end of the heel stick procedure. The calming time was measured from the time of the first cry to the first calming time.

Study Timeline

• Study Start: 2024-09-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-03-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 2 to 4 days
• Passed the hearing screening
• Birth weight between 2500-4400 grams
• Parents who know how to read, write and speak Turkish.

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Exclusion Criteria

• Parents with any mental problems
• Infants with any chronic disease and congenital anomalies.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NIPS (Neonatal Infant Pain Scale)	average 5 minutes) during the heel blood collection procedures (1 minute before the heel lance procedure (T-1 minute), during the procedure (T+0 second), and 2 minutes (T+2 minutes)]	It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım 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 Outcome Measures

Name	Time	Method
Crying times	[Time Frame: during the heel blood collection procedures (average 5 minutes)]	Duration of crying were recorded.
Processing time	[Time Frame: during the heel blood collection procedures (average 5 minutes)]	Duration of heel blood collection procedure were recorded.
The time to first calming	[Time Frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)]	The calming time was measured from the time of the first cry to the first calming time.

Trial Locations

Locations (1)

Burdur Mehmet Akif Ersoy University; 🇹🇷 Burdur, Bucak, Turkey