RetinopathyNCT05921981
Multisensory Stimulation Versus White Noise
A study testing Multisensorial Stimulation and White Noise in people with Retinopathy and Premature Retinopathy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants. Retinopathy is a common eye disorder among premature infants, which can cause visual impairments if not addressed. Read more about this study
- Who is it for?
- Ages 32 to 36 months
- Conditions the study is for
- Retinopathy, Premature Retinopathy
- What is being tested?
- Multisensorial Stimulation and White Noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 1 Jan 2024
- 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 32 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature newborns with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g, according to the records.
- Neonates undergoing a first-time eye exam to screen for retinopathy of prematurity.
- Newborns with their mother.
- Newborns who have not been fed in the last hour.
Who cannot join
- Newborns who need cardiopulmonary resuscitation (CPR) during the exam.
- Newborns experiencing apnea at the time of examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of White Noise and Multisensory Stimulation in Retinopathy Examination
This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants. Retinopathy is a common eye disorder among premature infants, which can cause visual impairments if not addressed. The research used a randomized controlled experimental design, with premature infants randomly assigned to either the white noise or multisensory stimulation group or control group. Physiological responses, behavioral indicators, and the pain of the retinopathy examination were measured. Trained healthcare professionals conducted the investigations in a controlled environment, and statistical analyses were employed to compare the outcomes between the three groups. The findings of this study have the potential to inform the development of more effective and well-tolerated examination protocols for premature infants, leading to improved visual outcomes and overall well-being for this vulnerable population.
Read the detailed description
This study aimed to compare the effectiveness of white noise and multisensory stimulation in retinopathy examination on premature infants. Retinopathy is a common eye disorder among premature infants that can lead to long-term visual impairments if left untreated. Therefore, finding effective interventions for retinopathy examinations is crucial for improving the overall visual health of these infants.
A randomized controlled experimental design was employed, with premature infants as the study participants. The infants were randomly assigned to three groups: the control group, the white noise group, and the multisensory stimulation group. The white noise group received auditory stimulation through the presentation of white noise, while the multisensory stimulation group received additional visual and tactile stimuli during the retinopathy examination.
Several outcome measures were used to evaluate the effectiveness of the interventions. These measures included physiological responses (e.g., heart rate, blood pressure), behavioral indicators (e.g., eye movement, crying), and overall examination success rate. The examination success rate was defined as the ability to complete the retinopathy examination without disturbances caused by infant distress or movement.
The study employed trained healthcare professionals who performed retinopathy examinations using standardized procedures. Data collection was conducted in a controlled environment to ensure consistency across three groups. Statistical analyses, such as ANOVA and chi-square tests, were employed to compare the outcomes between the three groups.
The findings of this study have the potential to contribute to the development of effective and well-tolerated retinopathy examination protocols for premature infants. By comparing the effects of white noise and multisensory stimulation, the study aims to provide insights into the most suitable intervention that can optimize the examination process, improve examination success rates, and minimize potential discomfort or distress experienced by infants.
It is anticipated that the results of this study will inform healthcare professionals and researchers about the benefits of auditory stimulation (white noise) and the additional advantages of multisensory stimulation during retinopathy examinations. Ultimately, this research aims to enhance the overall quality of care provided to premature infants, leading to improved visual outcomes and long-term well-being for this vulnerable population.
- Conditions
- Retinopathy, Premature Retinopathy
- Being tested
- Multisensorial Stimulation, White Noise
- Keywords
- preterm infants, Multisensorial stimulation, White Noise
- Medical subject headings
- Retinal Diseases, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensorial StimulationBehavioural
Multisensory stimulation in newborns involves the deliberate and simultaneous activation of multiple sensory modalities to provide sensory experiences that promote development and enhance learning. Newborns are naturally inclined to explore and make sense of their environment through their senses, including touch, sight, sound, taste, and smell.
White NoiseBehavioural
White Noise
| Study group | Role | What they receive |
|---|---|---|
| Multisensorial Stimulation Group | Experimental | The group to which multi-sensory stimulation will be applied during the retinopathy examination. Receives: Behavioral: Multisensorial Stimulation |
| White Noise Group | Active comparator | The group to which White Noise will be applied during the retinopathy examination. Receives: Behavioral: White Noise |
| Control Group | No intervention | The group that will receive routine care during the retinopathy examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Pain
The Premature Infant Pain Profile (PIPP) is a validated and widely used tool designed to assess pain in preterm infants. It takes into account physiological and behavioral indicators that are indicative of pain in this population. The PIPP scale includes the evaluation of facial expressions, gestational age, heart rate, oxygen saturation, and behavioral state to assess pain levels. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0-6 points, the pain is considered mild, 7-12 points moderate, 13-21 points severe.
Measured: first 30 minutes during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start10 Jul 2023
- Primary completion20 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Tasdemir, Akdeniz University
- Investigators
- Halil İbrahim HI Taşdemir, PhD, Study director, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921981
- Sponsor's protocol ID
- MAKU23-368
- Status last verified
- May 2024
- First submitted
- 19 Jun 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be decided later
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of White Noise and Multisensory Stimulation in Retinopathy Examination
- ClinicalTrials.gov ID
- NCT05921981
- Acronym / sponsor ID
- MAKU23-368
- Conditions
- Retinopathy, Premature Retinopathy
- Keywords
- preterm infants, Multisensorial stimulation, White Noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 27 Jun 2023 (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.
This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants. Retinopathy is a common eye disorder among premature infants, which can cause visual impairments if not addressed. The research used a randomized controlled experimental design, with premature infants randomly assigned to either the white noise or multisensory stimulation group or control group. Physiological responses, behavioral indicators, and the pain of the retinopathy examination were measured. Trained healthcare professionals conducted the investigations in a controlled environment, and statistical analyses were employed to compare the outcomes between the three groups. The findings of this study have the potential to inform the development of more effective and well-tolerated examination protocols for premature infants, leading to improved visual outcomes and overall well-being for this vulnerable population.
Detailed description
This study aimed to compare the effectiveness of white noise and multisensory stimulation in retinopathy examination on premature infants. Retinopathy is a common eye disorder among premature infants that can lead to long-term visual impairments if left untreated. Therefore, finding effective interventions for retinopathy examinations is crucial for improving the overall visual health of these infants.
A randomized controlled experimental design was employed, with premature infants as the study participants. The infants were randomly assigned to three groups: the control group, the white noise group, and the multisensory stimulation group. The white noise group received auditory stimulation through the presentation of white noise, while the multisensory stimulation group received additional visual and tactile stimuli during the retinopathy examination.
Several outcome measures were used to evaluate the effectiveness of the interventions. These measures included physiological responses (e.g., heart rate, blood pressure), behavioral indicators (e.g., eye movement, crying), and overall examination success rate. The examination success rate was defined as the ability to complete the retinopathy examination without disturbances caused by infant distress or movement.
The study employed trained healthcare professionals who performed retinopathy examinations using standardized procedures. Data collection was conducted in a controlled environment to ensure consistency across three groups. Statistical analyses, such as ANOVA and chi-square tests, were employed to compare the outcomes between the three groups.
The findings of this study have the potential to contribute to the development of effective and well-tolerated retinopathy examination protocols for premature infants. By comparing the effects of white noise and multisensory stimulation, the study aims to provide insights into the most suitable intervention that can optimize the examination process, improve examination success rates, and minimize potential discomfort or distress experienced by infants.
It is anticipated that the results of this study will inform healthcare professionals and researchers about the benefits of auditory stimulation (white noise) and the additional advantages of multisensory stimulation during retinopathy examinations. Ultimately, this research aims to enhance the overall quality of care provided to premature infants, leading to improved visual outcomes and long-term well-being for this vulnerable population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multisensorial Stimulation Group | Experimental | Behavioral: Multisensorial StimulationThe group to which multi-sensory stimulation will be applied during the retinopathy examination. |
| White Noise Group | Active comparator | Behavioral: White NoiseThe group to which White Noise will be applied during the retinopathy examination. |
| Control Group | No intervention | –The group that will receive routine care during the retinopathy examination |
Who may qualify
- Ages
- 32 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature newborns with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g, according to the records.
- Neonates undergoing a first-time eye exam to screen for retinopathy of prematurity.
- Newborns with their mother.
- Newborns who have not been fed in the last hour.
Key exclusion criteria (2 listed)
- Newborns who need cardiopulmonary resuscitation (CPR) during the exam.
- Newborns experiencing apnea at the time of examination
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 |
|---|---|---|
| Multisensorial StimulationMultisensory stimulation in newborns involves the deliberate and simultaneous activation of multiple sensory modalities to provide sensory experiences that promote development and enhance learning. Newborns are naturally inclined to explore and make sense of their environment through their senses, including touch, sight, sound, taste, and smell. | Behavioural | Multisensorial Stimulation Group |
| White NoiseWhite Noise | Behavioural | White Noise Group |
Primary outcome
Neonatal Pain
Time frame: first 30 minutes during procedure
The Premature Infant Pain Profile (PIPP) is a validated and widely used tool designed to assess pain in preterm infants. It takes into account physiological and behavioral indicators that are indicative of pain in this population. The PIPP scale includes the evaluation of facial expressions, gestational age, heart rate, oxygen saturation, and behavioral state to assess pain levels. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0-6 points, the pain is considered mild, 7-12 points moderate, 13-21 points severe.
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 17 May 2024.
- Individual participant dataSharing planned: Undecided. will be decided later
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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.
Halil İbrahim HI Taşdemir, PhD study director
Burdur Mehmet Akif Ersoy 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 Multisensorial Stimulation and White Noise in people with Retinopathy and Premature Retinopathy, run by Akdeniz 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 4 inclusion and 2 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 17 May 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?
Neonatal Pain (time frame: first 30 minutes during procedure). 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 17 May 2024.