Non-pharmacological Pain Management in Term Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance

NCT05524337

Pain, Acute Newborn

COMPLETED NA

The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

NCT04625010

Newborn Pain Maternal; Procedure +1 more

COMPLETED NA

Effect of Using White Noise, Embracing and Facilitated Tucking in Newborns

NCT04837326

Pain

COMPLETED NA

Facilitated Tucking Position, Gentle Human Touch Practices and Pain

NCT05948098

Pain Premature

COMPLETED NA

The Effect Of White Noise And Therapeutic Touch On Pain And Physiological Parameters In Premature Infants

NCT05395208

Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

White Noise Group:

The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. The baby was exposed to white noise for 2 minutes before the procedure.

Facilitated Tucking Group:

The baby's arms and legs were held in flexed positions close to the midline of the torso in side-lying position, so the baby was able to move his/her extremities. The baby was held in facilitated tucking position for one minute before the procedure.

White Noise+Facilitated Tucking Group:

The baby was exposed to white noise for 1 minute before the procedure. The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. At the second minute, when the white noise still continued to play, facilitated tucking was performed at the same time and the baby continued to listen to the white noise for 1 minute while in facilitated tucking position.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Pain scores of the babies before, during and after the procedure were evaluated independently by the researcher and the nurse other than the one who performed heel-stick sampling. Cohen's Kappa test was performed in the evaluation of the NIPS pain scores to test the concordance of the scores given to the same situation by 1 nurse and 1 researcher and it was found that the concordance of the scores given by 2 nurses was perfectly concordant (almost completely concordant) (Kappa Coefficient=0.953, p=0.027).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

White Noise

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).

Group Type EXPERIMENTAL

White Noise

Intervention Type OTHER

The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. The baby was exposed to white noise for 2 minutes before the procedure.

Facilitated Tucking

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).

Group Type EXPERIMENTAL

Facilitated Tucking

Intervention Type OTHER

The baby's arms and legs were held in flexed positions close to the midline of the torso in sidelying position, so the baby was able to move his/her extremities. The baby was held in facilitated tucking position for one minute before the procedure.

White Noise+Facilitated Tucking

Both applications performed together.

Group Type EXPERIMENTAL

White Noise+Facilitated Tucking

Intervention Type OTHER

The baby was exposed to white noise for 1 minute before the procedure. The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. At the second minute, when the white noise still continued to play, facilitated tucking was performed at the same time and the baby continued to listen to the white noise for 1 minute while in facilitated tucking position.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

White Noise

The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. The baby was exposed to white noise for 2 minutes before the procedure.

Intervention Type OTHER

Facilitated Tucking

The baby's arms and legs were held in flexed positions close to the midline of the torso in sidelying position, so the baby was able to move his/her extremities. The baby was held in facilitated tucking position for one minute before the procedure.

Intervention Type OTHER

White Noise+Facilitated Tucking

The baby was exposed to white noise for 1 minute before the procedure. The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. At the second minute, when the white noise still continued to play, facilitated tucking was performed at the same time and the baby continued to listen to the white noise for 1 minute while in facilitated tucking position.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes