Non-pharmacological Pain Management in Term Neonates

NCT04144543 | Completed

• 1 other identifier: Eskisehir Osmangazi University
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain severity (scores)

  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.

  2 MONTHS

Secondary Outcomes (1)

• Crying time

  2 MONTHS

Other Outcomes (3)

• Physiological Changes: Heart rate

  2 MONTHS

• Physiological Changes: Oxygen saturation

  2 MONTHS

• Physiological Changes: Respiration

  2 MONTHS

Study Arms (3)

White Noise

EXPERIMENTAL

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

Facilitated Tucking

EXPERIMENTAL

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

White Noise+Facilitated Tucking

EXPERIMENTAL

Both applications performed together.

Other: White Noise+Facilitated Tucking

Interventions

White Noise 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.

White Noise

Facilitated Tucking 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.

Facilitated Tucking

White Noise+Facilitated Tucking 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.

White Noise+Facilitated Tucking

Eligibility Criteria

• Age: Up to 3 Days
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankırı Karatekin Üniversitesi

Çankiri, 18200, Turkey (Türkiye)

Location

Related Publications (6)

• Karakoc A, Turker F. Effects of white noise and holding on pain perception in newborns. Pain Manag Nurs. 2014 Dec;15(4):864-70. doi: 10.1016/j.pmn.2014.01.002. Epub 2014 Feb 20.

  PMID: 24559599 BACKGROUND

• Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.

  PMID: 27751753 BACKGROUND

• Caglayan, N. (2011). The effect on pain of manipulating the preterm neonate into the facilitated tucking during drawing of blood from the heel. Turkey: Unpublished Master Thesis. Istanbul University Health Sciences Institute, Istanbul. Retrived from https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

  BACKGROUND

• Balci, S. (2006). Effect of white noise in colicky baby. Turkey: Unpublished Master's Thesis, Marmara University Institute of Health Sciences, Istanbul. Retrived from: https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

  BACKGROUND

• Akdovan, T. (1999). Assessment of pain in healthy newborns, investigation of the effect of the sucking and holding method. Turkey: Unpublisched Master's Dissertation. Marmara University Institute of Health Sciences, Istanbul. Retrived from: https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

  BACKGROUND

• Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

  PMID: 8413140 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Facilitated Tucking

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 30, 2019
• Study Start: July 1, 2017
• Primary Completion: August 9, 2017
• Study Completion: November 24, 2017
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

TU (1)