Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2023-07-10
2024-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Multisensorial Stimulation Group
The group to which multi-sensory stimulation will be applied during the retinopathy examination.
Multisensorial Stimulation
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 Noise Group
The group to which White Noise will be applied during the retinopathy examination.
White Noise
White Noise
Control Group
The group that will receive routine care during the retinopathy examination
No interventions assigned to this group
Interventions
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Multisensorial Stimulation
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 Noise
White Noise
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Newborns experiencing apnea at the time of examination
32 Months
36 Months
ALL
No
Sponsors
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Akdeniz University
OTHER
Responsible Party
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Halil Ibrahim Tasdemir
Assistant Professor
Principal Investigators
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Halil İbrahim HI Taşdemir, PhD
Role: STUDY_DIRECTOR
Burdur Mehmet Akif Ersoy University
Locations
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Akdeniz University
Antalya, , Turkey (Türkiye)
Countries
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Other Identifiers
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MAKU23-368
Identifier Type: -
Identifier Source: org_study_id
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