The Effect of Classical and Harp Music Practice on Premature Infants

NCT05647005 | Completed

• 1 other identifier: 2022/48
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to determine the effects of classical and harp music practice on physiological parameters (heart rate, respiratory rate and oxygen saturation value), cerebral oxygenation value (rSO2) and comfort of premature infants. It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design. The study will be carried out in Selcuk University Medical Faculty Hospital Neonatal Intensive Care Unit (NICU). A total of 84 premature babies will be included in the study, including the group to be listened to classical music (n=28), the group to be listened to harp music (n=28), and the control group (n=28). Triple blocks were created in the computer environment so that the premature infants to be included in the study could be assigned to three study groups using the balanced block randomization method (randomization.com). The randomization will be hidden from the researcher conducting the trial until the administration begins. The researcher will be given 84 envelopes and will begin to open the envelopes when they meet the baby. The researcher will learn which group each baby is in just before the application. Data collection tools; newborn Descriptive Information Form, physiological parameter and rSO2 follow-up form, and Premature infant comfort scale. The rSO2 value will be measured with the NIRS monitor. During the data collection phase, the purpose of the study will be explained to the parents of the premature infants by the researcher first, and informed about the study and consent will be obtained from the parents who agreed to participate in the study through the "Informed Voluntary Consent Form". To venture groups (classical and harp music); After feeding, a music box and a decibel meter will be placed in the incubator and classical music will be turned on at 50-55 dB. Just before the music is played, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. For 30 minutes, music will be played to the baby according to the intervention group (classical and harp music). After 30 minutes, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded again. Each session will be held in this way, a total of 15 sessions of music will be applied to thepremature infants, and the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded before and after each session. The control group is; premature infants in this group are those who take the clinical routine without being exposed to any music. After feeding, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded. They will not be exposed to any music and sound for 30 minutes and there will be no intervention. At the 30th minute, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Partial eta squared will be calculated for the effect size and the significance level will be accepted as p\<0.05.

Conditions

Music; Premature Infant; Cerebral Oxygenation; Comfort

Keywords

Classical music; Harp Music; Premature infant; Cerebral Oxygenation; Physiological Parameters; Comfort

Outcome Measures

Primary Outcomes (2)

• rSO2 level

  rSO2 level change

  before the intervention and the end of the intervention (30. minutes)

• comfort

  comfort level change

  before the intervention and the end of the intervention (30. minutes)

Secondary Outcomes (3)

• Heart rate

  before the intervention and the end of the intervention (30. minutes)

• Respiration rate

  before the intervention and the end of the intervention (30. minutes)

• SpO2 level

  before the intervention and the end of the intervention (30. minutes)

Study Arms (3)

Experiment 1: Classical music

EXPERIMENTAL

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. The sessions will be in the form of listening to classical music for 30 minutes after the babies are fed.

Other: Classical music

Experiment 2: Harp music

EXPERIMENTAL

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. Sessions will be in the form of listening to harp music for 30 minutes after the babies are fed.

Other: Harp music

Control

NO INTERVENTION

Premature babies in this group will not be interfered with by the newborn nurses for 30 minutes after feeding without any voice intervention.

Interventions

Classical music OTHER

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. Sessions will be in the form of listening to classical music for 30 minutes after the babies are fed.

Experiment 1: Classical music

Harp music OTHER

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. Sessions will be in the form of listening to harp music for 30 minutes after the babies are fed.

Experiment 2: Harp music

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Premature babies born between 30-36+6
• Postnatal babies at least 5 days old
• Babies with an APGAR score of 7 and above
• Babies with spontaneous breathing and stable hemodynamics
• No history of surgery

You may not qualify if:

• Babies with congenital hearing loss
• Babies using sedatives or muscle relaxants
• Absence of congenital anomalies, metabolic diseases, heart diseases and/or other serious diseases

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fatma Tas Arslan, professor

  Selcuk University

  STUDY DIRECTOR

• Tuğba Genç, nurse

  Selcuk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant, outcomes assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer (Phd)

Model Details: It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design.

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2022-July 2023 (7 months)

Locations

TU (1)