Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05921981 |
| Other study ID # |
MAKU23-368 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
