Non-pharmacological Pain Management in Term Neonates

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144543
• Other study ID #: Eskisehir Osmangazi University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: November 24, 2017

Study information

• Verified date: October 2019
• Source: Çankiri Karatekin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 24, 2017
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Çankiri Karatekin Üniversitesi	Çankiri

Sponsors (1)

Lead Sponsor	Collaborator
Çankiri Karatekin University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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

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

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

Karakoç A, Türker 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological Changes: Heart rate	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.	2 MONTHS
Other	Physiological Changes: Oxygen saturation	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.	2 MONTHS
Other	Physiological Changes: Respiration	The researcher recorded the respiration in minute (min) before and after heel blood collection. The study was completed with 90 infants.	2 MONTHS
Primary	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	Crying time	The researcher recorded the crying time in second (sec) during and after heel blood collection. The study was completed with 90 infants.	2 MONTHS