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The Effect of Classical and Harp Music Practice on Premature Infants

Primary Purpose

Music, Premature Infant, Cerebral Oxygenation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Classical music
Harp music
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Music focused on measuring Classical music, Harp Music, Premature infant, Cerebral Oxygenation, Physiological Parameters, Comfort

Eligibility Criteria

30 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experiment 1: Classical music

Experiment 2: Harp music

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

rSO2 level
rSO2 level change
comfort
comfort level change

Secondary Outcome Measures

Heart rate
Heart rate change
Respiration rate
Respiration rate change
SpO2 level
SpO2 level change

Full Information

First Posted
December 3, 2022
Last Updated
September 4, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05647005
Brief Title
The Effect of Classical and Harp Music Practice on Premature Infants
Official Title
The Effect of Classical and Harp Music Practice on Physiological Parameters, Cerebral Oxygenation and Comfort in Premature Infants: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music, Premature Infant, Cerebral Oxygenation, Comfort
Keywords
Classical music, Harp Music, Premature infant, Cerebral Oxygenation, Physiological Parameters, Comfort

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design.
Masking
Participant
Masking Description
Single (Participant, outcomes assessor)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1: Classical music
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 2: Harp music
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Premature babies in this group will not be interfered with by the newborn nurses for 30 minutes after feeding without any voice intervention.
Intervention Type
Other
Intervention Name(s)
Classical music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Harp music
Intervention Description
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.
Primary Outcome Measure Information:
Title
rSO2 level
Description
rSO2 level change
Time Frame
before the intervention and the end of the intervention (30. minutes)
Title
comfort
Description
comfort level change
Time Frame
before the intervention and the end of the intervention (30. minutes)
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate change
Time Frame
before the intervention and the end of the intervention (30. minutes)
Title
Respiration rate
Description
Respiration rate change
Time Frame
before the intervention and the end of the intervention (30. minutes)
Title
SpO2 level
Description
SpO2 level change
Time Frame
before the intervention and the end of the intervention (30. minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Babies with congenital hearing loss Babies using sedatives or muscle relaxants Absence of congenital anomalies, metabolic diseases, heart diseases and/or other serious diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevinc Akkoyun, Phd
Phone
+9003322231090
Email
sevincakkoyun87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tuğba Genç, nurse
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selcuk University

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Effect of Classical and Harp Music Practice on Premature Infants
IPD Sharing Time Frame
December 2022-July 2023 (7 months)

Learn more about this trial

The Effect of Classical and Harp Music Practice on Premature Infants

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