Nonpharmacological Methods in Heel Stick Pain

Effects of Using Various Heel-warming Methods Such As Warm Towel Warming and a Thermophore Heating Pad Warming Before Heel Prick on Newborns' Pain Level and Duration of Crying

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

Study Overview

• Status: Completed
• Conditions: Pain Management; Newborn Pain
• Intervention / Treatment: Procedure: Thermophore pad warming group; Procedure: Warm towel warming group; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balikesir
    • Bandirna, Balikesir, Turkey, 10200
      • Bandırma Onyedi Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermophore pad warming group; In the literature, (Lehmann, 1990; Shu et al., 2014), it is recommended that the heel should be warmed at a temperature ranging between 40°C and 45°C to increase blood flow before the heel prick test was performed. During the intervention, the newborn was wrapped with its own blanket leaving the extremity to be treated uncovered. Then, the thermophore heating pad filled with 40°C water was used to warm the sole of the foot for approximately 5 minutes just before the intervention. Attention was paid to prevent the thermophore heating pad from touching other parts of the baby's skin.	Procedure: Thermophore pad warming group; Thermophore pad waa using heel warming
Experimental: Warm towel warming group; In this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick. A clean cotton towel was used to warm the newborns' heels. Before the intervention, to warm the towel, it was wrapped in a thermophore pad filled with water at a temperature of approximately 40°C-45°C. The foot area and the heel of the newborn where the blood would be taken were wrapped with a warm towel for 3-4 minutes before heel prick was performed.	Procedure: Warm towel warming group; In this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick.
Experimental: Control group; In the newborns in this group, heel prick intervention was performed in line with the routine interventions of the clinic. The baby was wrapped in a blanket leaving the foot from which the blood sample would be taken unwrapped.	Other: Control group; in this group, heel prick intervention was performed in line with the routine interventions of the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Infant Pain Scale (NIPS)	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.	Pain levels of the newborns evaluated during the procedures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total criying time	Duration of crying were recorded.	The time of the procedure was measured from the beginning to the end of the heel stick procedure.

Collaborators and Investigators

• Sponsor: Diler Yilmaz

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BANU-D-YILMAZ-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available. I did not find It appropriate to share it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No