Premature RetinopathyNCT05203159
The Effect of Ocean Sound In Premature Retinopathy Examination
A study testing Ocean sound and Routine in people with Premature Retinopathy and Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination. Design: This is single-center. randomized controlled trial, double blind, parallel. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Retinopathy, Pain
- What is being tested?
- Ocean sound and Routine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2021to 13 Jun 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age ≤32 weeks
- Birth Weight ≤2000 grams
- Receiving babies that the clinician following the baby deems at risk for the development of ROP
- Receiving babies who will have their first ROP examination
- No sedative, opioid and anticonvulsant medication given before/during the examination
- Parents do not have diagnosed mental or mental problems and agree to participate in the research.
Who cannot join
- Presence of a condition that interferes with pain assessment (intracranial hemorrhage, neuro-motor developmental delay, etc.)
- Diagnosed hearing loss
- Performing a different painful procedure before the ROP (one hour)
- Being connected to a mechanical ventilator
- Congenital hearing problems in family members
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Meram Medical Faculty Hospital Neonatal Intensive Care Unit
Konya, Meram/Konya, 42080
About this study
Official title: The Effect of Ocean Sound on Physiological Parameters, Pain and Comfort Level In Premature Retinopathy Examination: A Randomized Controlled Study
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination.
Design: This is single-center. randomized controlled trial, double blind, parallel.
Read more
Hypotheses:
H0a: There is no difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H0b: There is no difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H0c: There is no difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
H1a: There is a difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H1b: There is a difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H1c: There is a difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
Method:
The population of the research will be preterm babies who are treated at Necmettin Erbakan University Meram Medical Faculty NICU and will have their first ROP examination.
Premature babies to be included in the study will be assigned to two study groups using the quadruple balanced block randomization method created in the computer environment according to their gestational age.
In the study, the baby information form, Premature Baby Pain Profile Scale-Revised Form (PIPP-R), and Premature Baby Comfort Scale (PBIC) created by the researcher by scanning the literature will be used.
Data will be collected by researcher GA. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to undergo an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study before the application.
The information contained in the "Baby Information Form" will be obtained from the nurse observation form and patient files. On the day of the ROP examination, babies who meet the inclusion criteria before the procedure will be recorded outside the incubator with a video recorder in the room where the ROP examination will be performed (a room with 45-50 dB sound). Two minutes before the ROP, the baby will be monitored and physiological parameters will be recorded, and one minute before the ROP, the experimental group will start to listen to the ocean sound (Video recordings will be evaluated by two experts, PIPP-R and PBIC). After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 20 cm from the baby's head and the sound level will be adjusted to an average of 55 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. Ocean Sound Group; The ocean sound recording will continue to be played during the ROP examination. Control Group; No sound will be played before, during and after the ROP examination.
Physiological parameters will be recorded at the 1st and 5th minutes after the procedure. (Video recordings will be evaluated by two experts for PIPP-R and PBIC). Video recording will be stopped.Ocean Sound Group;The ocean sound recording will be played at the 5th minute after the ROP inspection. Control Group; No sound will be played before, during and after the ROP examination.
- Conditions
- Premature Retinopathy, Pain
- Being tested
- Ocean sound, Routine
- Medical subject headings
- Retinopathy of Prematurity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocean soundOther
The experimental group will listen to ocean sound, starting at the 1st minute before the ROP examination and ending at the 5th minute after the ROP examination.
RoutineOther
No sound will be played before, during and after the ROP examination.
| Study group | Role | What they receive |
|---|---|---|
| ocean sound | Experimental | The group that will listen to the ocean sound Receives: Other: Ocean sound |
| control group | Active comparator | The group that will not listen to sound Receives: Other: Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
A pulse oximeter device will be used.
Measured: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
Oxygen Saturation
A pulse oximeter device will be used.
Measured: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
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 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
Premature Infant Comfort Scale (PBIC)
The scale was prepared in a 5-point Likert type consisting of 7 sub-dimensions and 35 items. The scale is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. It evaluates 7 parameters such as Alertness, Calmness/Agitation, Breathing Status or Crying, Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate.As the scores obtained from the scale increase, the baby's comfort level decreases. While 35 points indicates the lowest comfort level, 7 points indicates the highest comfort level.
Measured: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start25 Nov 2021
- Primary completion30 Nov 2022
- Study completion13 Jun 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 Premature RetinopathyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay ARSLAN, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203159
- Sponsor's protocol ID
- 12345
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arslan G, Geckil E, Satirtav Akdeniz G, Altunhan H. Effect of ocean sounds played during retinopathy of prematurity examinations on physiology, pain, and comfort levels: a randomized controlled trial. J Perinatol. 2026 Jul 29. doi: 10.1038/s41372-026-02839-y. Online ahead of print.
PubMed 42527547
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ocean Sound on Physiological Parameters, Pain and Comfort Level In Premature Retinopathy Examination: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05203159
- Acronym / sponsor ID
- 12345
- Conditions
- Premature Retinopathy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 24 Jan 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.
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination.
Design: This is single-center. randomized controlled trial, double blind, parallel.
Hypotheses:
H0a: There is no difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H0b: There is no difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H0c: There is no difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
H1a: There is a difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H1b: There is a difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H1c: There is a difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
Method:
The population of the research will be preterm babies who are treated at Necmettin Erbakan University Meram Medical Faculty NICU and will have their first ROP examination.
Premature babies to be included in the study will be assigned to two study groups using the quadruple balanced block randomization method created in the computer environment according to their gestational age.
In the study, the baby information form, Premature Baby Pain Profile Scale-Revised Form (PIPP-R), and Premature Baby Comfort Scale (PBIC) created by the researcher by scanning the literature will be used.
Data will be collected by researcher GA. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to undergo an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study before the application.
The information contained in the "Baby Information Form" will be obtained from the nurse observation form and patient files. On the day of the ROP examination, babies who meet the inclusion criteria before the procedure will be recorded outside the incubator with a video recorder in the room where the ROP examination will be performed (a room with 45-50 dB sound). Two minutes before the ROP, the baby will be monitored and physiological parameters will be recorded, and one minute before the ROP, the experimental group will start to listen to the ocean sound (Video recordings will be evaluated by two experts, PIPP-R and PBIC). After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 20 cm from the baby's head and the sound level will be adjusted to an average of 55 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. Ocean Sound Group; The ocean sound recording will continue to be played during the ROP examination. Control Group; No sound will be played before, during and after the ROP examination.
Physiological parameters will be recorded at the 1st and 5th minutes after the procedure. (Video recordings will be evaluated by two experts for PIPP-R and PBIC). Video recording will be stopped.Ocean Sound Group;The ocean sound recording will be played at the 5th minute after the ROP inspection. Control Group; No sound will be played before, during and after the ROP examination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ocean sound | Experimental | Other: Ocean soundThe group that will listen to the ocean sound |
| control group | Active comparator | Other: RoutineThe group that will not listen to sound |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age ≤32 weeks
- Birth Weight ≤2000 grams
- Receiving babies that the clinician following the baby deems at risk for the development of ROP
- Receiving babies who will have their first ROP examination
- No sedative, opioid and anticonvulsant medication given before/during the examination
Key exclusion criteria (5 listed)
- Presence of a condition that interferes with pain assessment (intracranial hemorrhage, neuro-motor developmental delay, etc.)
- Diagnosed hearing loss
- Performing a different painful procedure before the ROP (one hour)
- Being connected to a mechanical ventilator
- Congenital hearing problems in family members
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 |
|---|---|---|
| Ocean soundThe experimental group will listen to ocean sound, starting at the 1st minute before the ROP examination and ending at the 5th minute after the ROP examination. | Other | ocean sound |
| RoutineNo sound will be played before, during and after the ROP examination. | Other | control group |
Primary outcome
Heart Rate
Time frame: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
A pulse oximeter device will be used.
Oxygen Saturation
Time frame: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
A pulse oximeter device will be used.
Premature Baby Pain Profile Scale-Revised Form (PIPP-R)
Time frame: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
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.
Premature Infant Comfort Scale (PBIC)
Time frame: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).
The scale was prepared in a 5-point Likert type consisting of 7 sub-dimensions and 35 items. The scale is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. It evaluates 7 parameters such as Alertness, Calmness/Agitation, Breathing Status or Crying, Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate.As the scores obtained from the scale increase, the baby's comfort level decreases. While 35 points indicates the lowest comfort level, 7 points indicates the highest comfort level.
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 18 Nov 2023.
- Derived from this study: PubMed 42527547Arslan G, Geckil E, Satirtav Akdeniz G, Altunhan H. Effect of ocean sounds played during retinopathy of prematurity examinations on physiology, pain, and comfort levels: a randomized controlled trial. J Perinatol. 2026 Jul 29. doi: 10.1038/s41372-026-02839-y. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocean sound and Routine in people with Premature Retinopathy and Pain, run by Necmettin Erbakan 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 6 inclusion and 5 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 18 Nov 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?
Heart Rate (time frame: The measurement will start 2 minutes before the ROP examination and will end 5 minutes after the ROP examination (the examination ends with the removal of the speculum).). The study lists 4 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 NCT05203159, 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 18 Nov 2023.