Multisensory Stimulation Versus White Noise

Retinopathy Clinical Trial

Official title:

Comparison of the Effectiveness of White Noise and Multisensory Stimulation in Retinopathy Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921981
• Other study ID #: MAKU23-368
• Status: Completed
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Months to 36 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Newborns who need cardiopulmonary resuscitation (CPR) during the exam.
• Newborns experiencing apnea at the time of examination

Related Conditions & MeSH terms

• Premature Retinopathy
• Retinal Diseases
• Retinopathy
• Retinopathy of Prematurity

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first 30 minutes during procedure