Nonpharmacological Methods in Heel Stick Pain

NCT06847048 | Completed

• 1 other identifier: BANU-D-YILMAZ-003
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Management; Newborn Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total criying time

  The time of the procedure was measured from the beginning to the end of the heel stick procedure.

Study Arms (3)

Thermophore pad warming group

EXPERIMENTAL

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

Warm towel warming group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

Thermophore pad warming group PROCEDURE

Thermophore pad waa using heel warming

Thermophore pad warming group

Warm towel warming group PROCEDURE

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.

Warm towel warming group

Control group OTHER

in this group, heel prick intervention was performed in line with the routine interventions of the clinic.

Control group

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Diler Yilmaz: lead

Study Sites (1)

Bandırma Onyedi Eylül University

Bandirna, Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)