The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination

NCT05263973 | Completed

• 1 other identifier: 2022/122
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants. This is single-center, randomized controlled trial, double blind, parallel. Hypotheses: H1: The music applied during the ROP examination has an effect on the Revised Premature Infant Pain Profile (PIPP-R) score of the preterm infant. H2: The music applied during the ROP examination has an effect on the Preterm Infant Comfort Scale (PMI) score of the preterm infant. H3: Music applied during the ROP examination has an effect on the physiological parameters (peak heart rate, O2 saturation) of the preterm infant. H4: The music applied during the ROP examination has an effect on the crying time of the preterm infant during the procedure. Method: The study will be performed with preterm infants (n=28) hospitalized in the neonatal intensive care unit of a tertiary hospital. Premature infants to be included in the study will be assigned to two study groups using the block randomization method created in the computer environment according to their gestational age, gender, birth weight. The data in the study were will be collected using the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod. Data will be collected by researcher ABÇ. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study. Questionaire Form for Preterm Newborns and Their Parents will be obtained from the nurse observation form and patient files. Four minutes before the ROP, the infant will be monitored and physiological parameters will be recorded, and three minutes before the ROP, the experimental group will start to listen to music (Video recordings will be evaluated by three experts, PIPP-R and PICS). The music recording will continue to be played during the ROP examination for music group. No application will be made for the control group other than the clinical routines.

Conditions

ROP Examination

Outcome Measures

Primary Outcomes (6)

• Premature Infant Comfort Scale (PBIC)

  According to the PICS, a score between 7-35 is obtained from the scale. A high score from the scale indicates a low level of comfort.

  The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.

• Premature Baby Pain Profile Scale-Revised Form (PIPP-R)

  The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral elements are scored as 0, 1, 2, 3, reflecting the difference between the values at baseline and during the procedure in each variable. Contextual items (behavioral status and CI) are scored as 3, 2, 1, 0 only at the beginning of the pain assessment (before touching the baby). According to the PIPP-R, the baby's pain is evaluated over the total score. Accordingly, the highest score that can be obtained from the PIPP-R scale for preterm newborns is 21 and 18 for term newborns.

  The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.

• Physiological parameters- heart rate

  Heart rate

  The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.

• Physiological parameters- oxygen saturation

  Oxygen saturation

  The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.

• Physiological parameters- respiratory rate

  Respiratory rate

  The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.

• Physiological parameters- crying time

  Crying time

  immediately after the ROP examination.

Study Arms (2)

Music group

EXPERIMENTAL

The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 12 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination.

Other: Music

No intervention

NO INTERVENTION

The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made.

Interventions

Music OTHER

The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 12 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination

Music group

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \<2000 g,
• Gestational age ≤32 weeks,
• Have not passed the first 2 ROP inspections,
• Not receiving ventilatory support (not intubated or positive pressure ventilation support) for the last 72 hours,
• Vital signs within normal limits (without tachycardia, tachypnea, hyperthermia, hypothermia, dyspnea, intercostal or subcostal retraction),
• Not having any congenital anomalies (eye, neurological) that may adversely affect the examination,
• No hearing problem,
• No painful intervention is performed at least 30 minutes before the ROP examination,
• Preterm newborns whose corrected/postnatal age is 28-36 weeks at the time of examination,
• Newborns whose mothers want to participate in the study will be included in the study.

You may not qualify if:

• Clinic condition worsening during working,
• Diagnosed with hydrocephalus, necrotizing enterocolitis, indirect hyperbilirubinemia,
• Receiving analgesic treatment,
• Newborns whose mothers want to withdraw from the study will be excluded from the study groups.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes university

Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

• Cuhaci AB, Efe YS, Gunes T. The effect of music on pain, comfort, and physiological parameters during premature retinopathy examination. J Pediatr Nurs. 2024 Sep-Oct;78:149-157. doi: 10.1016/j.pedn.2024.06.020. Epub 2024 Jun 28.

  PMID: 38943838 DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yağmur Sezer Efe, Assist. Prof.

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Yağmur Sezer Efe

Model Details: Music

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: March 10, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

TU (1)