ROP ExaminationNCT05263973
The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination
A study testing Music in people with ROP Examination, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- ROP Examination
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 10 Jan 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 Up to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity: A Randomized Controlled Study
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:
Read more
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.
Read the detailed description
This randomized controlled experimental study is planned in order to determine the effect of music on pain, comfort and physiological parameters in preterm infants in ROP examination matched for gestational age, gender and birth weight. The research sample will consist of 28 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 10 and 30 in different studies in which music was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 14 according to α=95% confidence level and 90% power. In the study, it was planned to have 14 infants in the music and control groups. After reaching 28 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. All bodies of preterm infants will be recorded with a visible video camera for an average of 10 minutes, 4 minutes before the start of the ROP examination and 4 minutes after the completion of the ROP examination (for PIPP-R and PICS scores). The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 10 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination. After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 45 cm from the head of infant and the sound level will be adjusted to an average of 45-60 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye (mean ROP time 1.61 ±1.59). The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Data will be collected with 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.
- Conditions
- ROP Examination
- Being tested
- Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after the ROP examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start10 Mar 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ROP ExaminationStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Music
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur Sezer Efe, TC Erciyes University
- Investigators
- Yağmur Sezer Efe, Assist. Prof., Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263973
- Sponsor's protocol ID
- 2022/122
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38943838
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05263973
- Acronym / sponsor ID
- 2022/122
- Conditions
- ROP Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 3 Mar 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.
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.
Detailed description
This randomized controlled experimental study is planned in order to determine the effect of music on pain, comfort and physiological parameters in preterm infants in ROP examination matched for gestational age, gender and birth weight. The research sample will consist of 28 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 10 and 30 in different studies in which music was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 14 according to α=95% confidence level and 90% power. In the study, it was planned to have 14 infants in the music and control groups. After reaching 28 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. All bodies of preterm infants will be recorded with a visible video camera for an average of 10 minutes, 4 minutes before the start of the ROP examination and 4 minutes after the completion of the ROP examination (for PIPP-R and PICS scores). The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 10 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination. After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 45 cm from the head of infant and the sound level will be adjusted to an average of 45-60 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye (mean ROP time 1.61 ±1.59). The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Data will be collected with 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Music
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: MusicThe 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. |
| 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. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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),
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| MusicThe 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 group |
Primary outcome
Premature Infant Comfort Scale (PBIC)
Time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
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.
Premature Baby Pain Profile Scale-Revised Form (PIPP-R)
Time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
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.
Physiological parameters- heart rate
Time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
Heart rate
Physiological parameters- oxygen saturation
Time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
Oxygen saturation
Physiological parameters- respiratory rate
Time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.
Respiratory rate
Physiological parameters- crying time
Time frame: immediately after the ROP examination.
Crying time
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 12 Oct 2023.
- Derived from this study: PubMed 38943838Cuhaci 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.
Related trials for ROP Examination
RecruitingObservational study
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
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Enrolling by invitation
Pain and Comfort in the Examination of Retinopathy of Prematurity
Premature, Retinopaty of Prematurity
Not yet recruitingPhase 1
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Drug Safety
Recruiting
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
Retinopathy of Prematurity (ROP)
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.
Yağmur Sezer Efe, Assist. Prof. principal investigator
TC Erciyes 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 Music in people with ROP Examination, run by TC Erciyes 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 10 inclusion and 4 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 12 Oct 2023. 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?
Premature Infant Comfort Scale (PBIC) (time frame: The measurement will start 4 minutes before the ROP examination and will end 4 minutes after the ROP examination.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263973, which also lists 1 linked publication.
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 12 Oct 2023.