Nonpharmacological Methods in Heel Stick Pain

Diler Yilmaz

Status: Completed

Conditions: Newborn Pain; Pain Management

Treatments: Procedure: Thermophore pad warming group; Procedure: Warm towel warming group; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06847048

BANU-D-YILMAZ-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 1 to 2 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

Thermophore pad warming group

Experimental group

Description:

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.

Treatment:

Procedure: Thermophore pad warming group

Warm towel warming group

Experimental group

Description:

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.

Treatment:

Procedure: Warm towel warming group

Control group

Experimental group

Description:

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.

Treatment:

Other: Control group