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Completed

NCT Number: NCT06847048

Nonpharmacological Methods in Heel Stick Pain

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

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Key information

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bandırma Onyedi Eylül University

Bandirna, Balıkesir, 10200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermophore pad warming group

Procedure

Thermophore pad waa using heel warming

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.

Control Group

Other

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

Primary outcomes

  1. Neonatal Infant Pain Scale (NIPS)

    Time frame: 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 outcomes

  1. Total criying time

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

    Duration of crying were recorded.

Sponsors and collaborators

Lead sponsor

Diler Yilmaz

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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