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Multisensory Stimulation Versus White Noise

Primary Purpose

Retinopathy, Premature Retinopathy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multisensorial Stimulation
White Noise
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinopathy focused on measuring preterm infants, Multisensorial stimulation, White Noise

Eligibility Criteria

32 Months - 36 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Multisensorial Stimulation Group

White Noise Group

Control Group

Arm Description

The group to which multi-sensory stimulation will be applied during the retinopathy examination.

The group to which White Noise will be applied during the retinopathy examination.

The group that will receive routine care during the retinopathy examination

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2023
Last Updated
July 6, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05921981
Brief Title
Multisensory Stimulation Versus White Noise
Official Title
Comparison of the Effectiveness of White Noise and Multisensory Stimulation in Retinopathy Examination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy, Premature Retinopathy
Keywords
preterm infants, Multisensorial stimulation, White Noise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multisensorial Stimulation Group
Arm Type
Experimental
Arm Description
The group to which multi-sensory stimulation will be applied during the retinopathy examination.
Arm Title
White Noise Group
Arm Type
Active Comparator
Arm Description
The group to which White Noise will be applied during the retinopathy examination.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The group that will receive routine care during the retinopathy examination
Intervention Type
Behavioral
Intervention Name(s)
Multisensorial Stimulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
White Noise
Intervention Description
White Noise
Primary Outcome Measure Information:
Title
Neonatal Pain
Description
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.
Time Frame
first 30 minutes during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halil ibrahim Taşdemir, PhD
Phone
+905443356575
Ext
8254
Email
dibrahimtasdemir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz DT Taşdemir, RN
Phone
+905378257687
Ext
8254
Email
denizdtasdemir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil İbrahim HI Taşdemir, PhD
Organizational Affiliation
Burdur Mehmet Akif Ersoy University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halil ibrahim RN Taşdemir, PhD
Phone
+905443356575
Ext
8254
Email
hitasdemir@mehmetakif.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
will be decided later

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Multisensory Stimulation Versus White Noise

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