Nonpharmacological Methods in Heel Stick Pain

NCT ID: NCT06847048

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-02-01

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.

Conditions

Pain Management; Newborn Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Thermophore pad warming group

Intervention Type: PROCEDURE

Thermophore pad waa using heel warming

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.

Group Type: EXPERIMENTAL

Warm towel warming group

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

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

Interventions

Thermophore pad warming group

Thermophore pad waa using heel warming

Intervention Type: 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.

Intervention Type: PROCEDURE

Control group

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diler Yilmaz

OTHER

Sponsor Role: lead

Responsible Party

Diler Yilmaz

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bandırma Onyedi Eylül University

Bandirna, Balıkesir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BANU-D-YILMAZ-003

Identifier Type: -

Identifier Source: org_study_id