Non-pharmacological Pain Management in Term Neonates

Çankırı Karatekin University

Status: Completed

Conditions: Pain

Treatments: Other: Facilitated Tucking; Other: White Noise; Other: White Noise+Facilitated Tucking

Study type: Interventional

Funder types: Other

Identifiers

NCT04144543

Eskisehir Osmangazi University

Details and patient eligibility

About

A randomised clinical trial in a single centre. This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

The study was conducted on 90 babies. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

Full description

Aims and objectives: This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

Design: A randomised clinical trial in a single centre. Methods: The study sample size was determined by the free-software G* Power. Based on the power analysis performed prior to the study in order to determine the number of babies to be included in the sample group (with β=0.14087 and α=0.05 risk, Power=0.85913), according to the study by Karakoc and Turker (2014), it was found that 27 neonates should be included in each group. The study was conducted on 90 babies, between July 1, 2017 - August 9, 2017. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

Enrollment: 90 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being term baby
• Being with mother
• Being a healthy baby
• Being able fed orally
• Being fed at least half an hour before the procedure
• Being able to draw blood at the first try (since the pain level will change on the second try)
• Agreed to participate in the study and gave verbal consent were included in the study.

Exclusion criteria

• Having received analgesics and/or sedatives within the last 24 hours
• Having any complications that prevent pain evaluation (e.g. intracranial hemorrhage, neuromotor growth retardation, etc.)
• Having undergone any painful procedures within the last hour (e.g. blood drawing, aspiration, ophthalmologic examination, etc.)
• Prior history of surgery
• Being connected to mechanical ventilator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 3 patient groups

White Noise

Experimental group

Description:

The "white noise" used in our study is a fragment called "Bebeğiniz ağlamasın-2" from "Kolik" album of Buzuki Orhan Osman, which was used in similar studies (Balci, 2006; Karakoc \& Turker, 2014; Kucukoglu et al., 2016).Since the white noise is a continuously monotonous sound, which is in the form of a hum, it resembles the sounds in mother's womb (Balci, 2006).

Treatment:

Other: White Noise

Facilitated Tucking

Experimental group

Description:

Facilitated tucking is the procedure of holding the baby's arms and legs in a flexed position close to the midline of the torso, and the baby is able to move his/her extremities during this procedure (Caglayan, 2011).

Treatment:

Other: Facilitated Tucking

White Noise+Facilitated Tucking

Experimental group

Description:

Both applications performed together.

Treatment:

Other: White Noise+Facilitated Tucking