Non-pharmacological Pain Management in Term Neonates

Sponsor

Çankırı Karatekin University (Other)

Overall Status

Completed

CT.gov ID

NCT04144543

Collaborator

(none)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: White Noise Other: Facilitated Tucking Other: White Noise+Facilitated Tucking	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Double (Care Provider, Investigator)

Masking Description:

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).

Primary Purpose:

Prevention

Official Title:

Experimental Randomized Study: The Effect of White Noise and Facilitated Tucking Applications During Heel-Stick Sampling on Pain in Term Babies

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Aug 9, 2017

Actual Study Completion Date :

Nov 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Other: 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.
Experimental: 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).	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.
Experimental: White Noise+Facilitated Tucking Both applications performed together.	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.

Arm

Intervention/Treatment

Experimental: 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).

Other: 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.

Experimental: 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).

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.

Experimental: White Noise+Facilitated Tucking

Both applications performed together.

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.

Outcome Measures

Primary Outcome Measures

Pain severity (scores) [2 MONTHS]
Pain was evaluated separately by NIPS by two individuals, one investigator and one nursing nurse. The scores given by the investigator and the nurse were used to determine pain scores before, during and after heel blood collection. Pain severity was expressed as mean score NIPS.Neonatal Infant Pain Scale (NIPS) was used in the evaluation of the pain of the neonates. This scale was developed by Lawrence et al. (1993). The validity and reliability of the Turkish version of the test were assessed by Akdovan (1999). There are six variables in the scale. These are baby's breathing pattern, wakefulness, crying, facial movements and arm and leg movements. These variables are scored between 0-1. Only crying is scored between 0-2. The total score is between 0-7. The resulting score is directly proportional to the severity of the pain. That is, as the score increases, the severity of the pain increases (Akdovan, 1999). The study was completed with 90 infants.

Secondary Outcome Measures

Crying time [2 MONTHS]
The researcher recorded the crying time in second (sec) during and after heel blood collection. The study was completed with 90 infants.

Other Outcome Measures

Physiological Changes: Heart rate [2 MONTHS]
The pulse oximetry probe was attached to a non-heeled foot to measure heart in second (sec) before, during and after heel blood collection in each infant. The study was completed with 90 infants.
Physiological Changes: Oxygen saturation [2 MONTHS]
The pulse oximetry probe was attached to a non-heeled foot to measure oxygen saturation in percent (%) before, during and after heel blood collection in each infant. The study was completed with 90 infants.
Physiological Changes: Respiration [2 MONTHS]
The researcher recorded the respiration in minute (min) before and after heel blood collection. The study was completed with 90 infants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Çankırı Karatekin Üniversitesi	Çankiri		Turkey	18200

Sponsors and Collaborators

Çankırı Karatekin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Aylin PEKYİGİT, Research Assistant, Çankırı Karatekin University

ClinicalTrials.gov Identifier:

NCT04144543

Other Study ID Numbers:

Eskisehir Osmangazi University

First Posted:

Oct 30, 2019

Last Update Posted:

Oct 30, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 30, 2019