The Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns

NCT04033874 | Unknown

• 1 other identifier: Eskisehir Osmangazi University
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure

Conditions

Newborn

Keywords

Heel stick; Newborn; NIPS; Pain levels; Crying times; Voice decibels

Outcome Measures

Primary Outcomes (3)

• Crying times

  Newborns' crying times during heel-stick procedure will be assessed with the stopwatch

  Five months

• Voice decibels

  Newborns' voice decibels during heel-stick procedure will be assessed with the sound decibel meter

  Five months

• Pain levels

  Newborns' pain levels during heel-stick procedure will be assessed with NIPS (Neonatal Infant Pain Scale)

  Five months

Study Arms (4)

Kangaroo care

EXPERIMENTAL

Heel stick procedure will be performed during kangaroo care. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.

Other: kangaroo care

Mother's lap

EXPERIMENTAL

Heel stick procedure will be performed during newborns who are holding on their mother's lap. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.

Other: holding on the mother's lap

White noise

EXPERIMENTAL

Heel stick procedure will be performed during newborns listened to white noise. For the white noise; the track named "do not cry your baby, pt. 2" will be played in Orhan Osman's Colic album. The white noise level will be adjusted to an average of 55 decibels. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.

Other: white noise listening

Ambient sound

EXPERIMENTAL

Heel stick procedure will be performed during newborns listened to ambient sound. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.

Other: ambient sound listening

Interventions

kangaroo care OTHER

kangaroo care

Kangaroo care

holding on the mother's lap OTHER

holding on the mother's lap

Mother's lap

white noise listening OTHER

white noise listening

White noise

ambient sound listening OTHER

ambient sound listening

Ambient sound

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestation age is between 34-42 weeks
• Birth weight is between 2500-4000 gr
• Apgar score of 1 minute and 5 minutes 8 and above
• Passing the newborn hearing screening test
• To being followed in the neonatal intensive care unit
• To being fed at least half an hour before the procedure
• To being agreed to participate in the study by parents
• To being never received mechanical ventilation / CPAP support after birth
• Having none of congenital anomaly

You may not qualify if:

• Inability to take blood the first attempt, as the pain level may change
• Failure of the newborn to pass the hearing screening test
• Newborns hospitalized from polyclinic and emergency department because heel blood was taken before
• Refusing to participate in the study by parents

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Gao H, Xu G, Gao H, Dong R, Fu H, Wang D, Zhang H, Zhang H. Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2015 Jul;52(7):1157-65. doi: 10.1016/j.ijnurstu.2015.04.006. Epub 2015 Apr 9.

  PMID: 25912524 RESULT

• Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.

  PMID: 28205208 RESULT

• Zhu J, Hong-Gu H, Zhou X, Wei H, Gao Y, Ye B, Liu Z, Chan SW. Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in China: a randomized controlled trial. Midwifery. 2015 Mar;31(3):365-72. doi: 10.1016/j.midw.2014.11.001. Epub 2014 Nov 11.

  PMID: 25467598 RESULT

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Özlem Örsal, Ph.D.

  Eskişehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pınar Duru, Ph.D

CONTACT

+90(222)2393750; pinarduruu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The prospective, randomized controlled trial including pre and post tests of four groups

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: July 10, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)