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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06847048
Enrollment
147
Registered
2025-02-26
Start date
2017-03-01
Completion date
2018-02-01
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Pain, Pain Management

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.

Interventions

PROCEDUREThermophore pad warming group

Thermophore pad waa using heel warming

PROCEDUREWarm 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.

OTHERControl group

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

Sponsors

Diler Yilmaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Prospective, randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
1 Days to 2 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Infant Pain Scale (NIPS)Pain levels of the newborns evaluated during the proceduresNeonatal 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

MeasureTime frameDescription
Total criying timeThe time of the procedure was measured from the beginning to the end of the heel stick procedure.Duration of crying were recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026