Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05921981
Study type Interventional
Source Akdeniz University
Contact
Status Completed
Phase N/A
Start date May 10, 2023
Completion date January 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Completed NCT01955135 - Anesthesia for Retinopathy of Prematurity Phase 4
Not yet recruiting NCT00331370 - Hypertension Related Damage to the Microcirculation in South Asian: Emergence, Predictive Power and Reversibility N/A
Recruiting NCT02466607 - Study of Stimulus Parameters in Flicker Electroretinogram (ERG) N/A
Recruiting NCT01552993 - Registration and Treatment of Pain During Eye Examination of Prematurity N/A
Completed NCT02321904 - Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Completed NCT00259701 - Microvascular Reactivity. N/A
Completed NCT03901898 - Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance N/A
Recruiting NCT06239064 - Early Genetic Identification of Obesity
Recruiting NCT03011541 - Stem Cell Ophthalmology Treatment Study II N/A
Completed NCT01793090 - EPI-743 in Cobalamin C Defect: Effects on Visual and Neurological Impairment Phase 2
Withdrawn NCT00618644 - Ranibizumab for Neovascularization in Sickle Cell Retinopathy N/A
Recruiting NCT03542734 - Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly
Active, not recruiting NCT06355219 - Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines
Completed NCT01412905 - Telemedicine Retinal Screening Utilizing a Mobile Medical Unit
Recruiting NCT02702973 - Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy N/A
Completed NCT00828425 - Management of Diabetes Mellitus Patients With Retinopathy N/A
Not yet recruiting NCT04008121 - Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium Early Phase 1
Terminated NCT00969956 - Time To Complications Occurs in Diabetes
Recruiting NCT04819893 - Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.