Clinical trial NCT06847048: Nonpharmacological Methods in Heel Stick Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Newborn Pain
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 147
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: Pain levels of the newborns evaluated during the procedures
Secondary outcomes:
measure: Total criying time
timeFrame: The time of the procedure was measured from the beginning to the end of the heel stick procedure.
Other outcomes:
Locations:
city: Bandirna
country: Turkey
facility: Bandırma Onyedi Eylül University
state: Balikesir
Study officials:
References: