Clinical trial NCT04144543: Non-pharmacological Pain Management in Term Neonates
Official title: Experimental Randomized Study: The Effect of White Noise and Facilitated Tucking Applications During Heel-Stick Sampling on Pain in Term Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 90
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain severity (scores)
timeFrame: 2 MONTHS
Secondary outcomes:
measure: Crying time
timeFrame: 2 MONTHS
Other outcomes:
measure: Physiological Changes: Heart rate
timeFrame: 2 MONTHS
measure: Physiological Changes: Oxygen saturation
timeFrame: 2 MONTHS
measure: Physiological Changes: Respiration
timeFrame: 2 MONTHS
Locations:
city: Çankiri
country: Turkey
facility: Çankırı Karatekin Üniversitesi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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.