Multisensory Stimulation Versus White Noise

NCT05921981 | Completed

• 1 other identifier: MAKU23-368
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy; Premature Retinopathy

Keywords

preterm infants; Multisensorial stimulation; White Noise

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Multisensorial Stimulation Group

EXPERIMENTAL

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

Behavioral: Multisensorial Stimulation

White Noise Group

ACTIVE COMPARATOR

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

Behavioral: White Noise

Control Group

NO INTERVENTION

The group that will receive routine care during the retinopathy examination

Interventions

Multisensorial Stimulation BEHAVIORAL

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.

Multisensorial Stimulation Group

White Noise BEHAVIORAL

White Noise

White Noise Group

Eligibility Criteria

• Age: 32 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinal Diseases; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Halil İbrahim HI Taşdemir, PhD

  Burdur Mehmet Akif Ersoy University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: July 10, 2023
• Primary Completion: November 20, 2023
• Study Completion: January 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

TU (1)