MusicNCT05647005
The Effect of Classical and Harp Music Practice on Premature Infants
A study testing Classical music and Harp music in people with Music and Premature Infant, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Music, Premature Infant, Cerebral Oxygenation
- What is being tested?
- Classical music and Harp music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Babies with congenital hearing loss
- Babies using sedatives or muscle relaxants
- Absence of congenital anomalies, metabolic diseases, heart diseases and/or other serious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Classical and Harp Music Practice on Physiological Parameters, Cerebral Oxygenation and Comfort in Premature Infants: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Music, Premature Infant, Cerebral Oxygenation, Comfort
- Being tested
- Classical music, Harp music
- Keywords
- Classical music, Harp Music, Premature infant, Cerebral Oxygenation, Physiological Parameters, Comfort
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical musicOther
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.
Harp musicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rSO2 level
rSO2 level change
Measured: before the intervention and the end of the intervention (30. minutes)
comfort
comfort level change
Measured: before the intervention and the end of the intervention (30. minutes)
Secondary outcomes (3)
Heart rate
Heart rate change
Measured: before the intervention and the end of the intervention (30. minutes)
Respiration rate
Respiration rate change
Measured: before the intervention and the end of the intervention (30. minutes)
SpO2 level
SpO2 level change
Measured: before the intervention and the end of the intervention (30. minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinc Akkoyun, Selcuk University
- Investigators
- Fatma Tas Arslan, professor, Study director, Selcuk UniversityTuğba Genç, nurse, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647005
- Sponsor's protocol ID
- 2022/48
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Effect of Classical and Harp Music Practice on Premature Infants
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Classical and Harp Music Practice on Physiological Parameters, Cerebral Oxygenation and Comfort in Premature Infants: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05647005
- Acronym / sponsor ID
- 2022/48
- Conditions
- Music, Premature Infant, Cerebral Oxygenation, Comfort
- Keywords
- Classical music, Harp Music, Premature infant, Cerebral Oxygenation, Physiological Parameters, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design.
| Arm | Type | Receives |
|---|---|---|
| Experiment 1: Classical music | Experimental | Other: Classical musicA 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. |
| Experiment 2: Harp music | Experimental | Other: Harp musicA 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. |
| 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. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Babies with congenital hearing loss
- Babies using sedatives or muscle relaxants
- Absence of congenital anomalies, metabolic diseases, heart diseases and/or other serious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classical musicA 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. | Other | Experiment 1: Classical music |
| Harp musicA 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 | Experiment 2: Harp music |
Primary outcome
rSO2 level
Time frame: before the intervention and the end of the intervention (30. minutes)
rSO2 level change
comfort
Time frame: before the intervention and the end of the intervention (30. minutes)
comfort level change
3 secondary outcomes
Heart rate
Time frame: before the intervention and the end of the intervention (30. minutes)
Respiration rate
Time frame: before the intervention and the end of the intervention (30. minutes)
SpO2 level
Time frame: before the intervention and the end of the intervention (30. minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. The Effect of Classical and Harp Music Practice on Premature Infants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Tas Arslan, professor study director
Selcuk University
Tuğba Genç, nurse study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical music and Harp music in people with Music and Premature Infant, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rSO2 level (time frame: before the intervention and the end of the intervention (30. minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.