Nonpharmacological Methods in Heel Stick Pain

Not Applicable

Completed

• Conditions: Pain Management; Newborn Pain

• Registration Number: NCT06847048
• Lead Sponsor: Diler Yilmaz

Brief Summary

In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns.

Study hypotheses are; Hypothesis 1. Using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level.

Hypothesis 2. Using the warm towel warming method in newborns before heel prick reduces the newborn's pain level.

Hypothesis 3. Using the thermophore pad warming method in newborns before heel prick reduces the duration of crying.

Hypothesis 4. Using the warm towel warming method in newborns before heel prick reduces the duration of crying

Detailed Description

Heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. In several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick.

This study is a prospective, randomized and controlled trial. In this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined.

The minimum number of newborns to be included in the study was calculated as 150 using the G\*Power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). The 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50).

Data Collection Tools To collect the study data, the "Descriptive Information Form", "Follow-up Form", and "Neonatal Infant Pain Scale" were used.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-23
• Last Update Submitted: 2025-02-23
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Having been born at 38-42 weeks of gestation,
• having a birth weight of 2500 g and above,
• having a 5-min APGAR score of 7 and above,
• having stable health,
• having been fed within an hour before the intervention, being calm and not crying before the intervention,
• having a postnatal age of 24-72 hours, and
• undergoing heel prick for the first time

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale (NIPS)	Pain levels of the newborns evaluated during the procedures	Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.

Secondary Outcome Measures

Name	Time	Method
Total criying time	The time of the procedure was measured from the beginning to the end of the heel stick procedure.	Duration of crying were recorded.

Trial Locations

Locations (1)

Bandırma Onyedi Eylül University; 🇹🇷 Bandirna, Balikesir, Turkey

Bandırma Onyedi Eylül University

🇹🇷Bandirna, Balikesir, Turkey