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Multisensory Stimulation Versus White Noise

A

Akdeniz University

Status

Completed

Conditions

Retinopathy
Premature Retinopathy

Treatments

Behavioral: White Noise
Behavioral: Multisensorial Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05921981
MAKU23-368

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

32 to 36 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Multisensorial Stimulation Group
Experimental group
Description:
The group to which multi-sensory stimulation will be applied during the retinopathy examination.
Treatment:
Behavioral: Multisensorial Stimulation
White Noise Group
Active Comparator group
Description:
The group to which White Noise will be applied during the retinopathy examination.
Treatment:
Behavioral: White Noise
Control Group
No Intervention group
Description:
The group that will receive routine care during the retinopathy examination

Trial contacts and locations

1

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Central trial contact

Halil ibrahim Taşdemir, PhD; Deniz DT Taşdemir, RN

Data sourced from clinicaltrials.gov

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