Multisensory Stimulation in Infants for Eye Examination

NCT05830409 | Completed DMC

• 1 other identifier: MAKU23-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns. It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.

Conditions

Premature Retinopathy; Pain, Eye

Keywords

preterm infants; Multisensorial stimulation

Outcome Measures

Primary Outcomes (1)

• Pain level

  Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.

  first 30 minutes during procedure

Secondary Outcomes (2)

• Heart rate

  first 30 minutes during procedure

• Oksigen saturation

  first 30 minutes during procedure

Study Arms (2)

Multisensorial Stimulation Group

EXPERIMENTAL

Preterm newborns who will receive multisensory stimulation during the eye examination.

Behavioral: Multisensorial Stimulation

Control Group

NO INTERVENTION

Preterm newborns who will receive routine care during the eye examination

Interventions

Multisensorial Stimulation BEHAVIORAL

Strategies such as touching, calling, making sense of smell, entering the eye area, and activating the sense of taste will be applied to activate the five senses of the newborn.

Multisensorial Stimulation Group

Eligibility Criteria

• Age: 32 Weeks - 36 Months
• Gender Eligibility Details: Newborns younger than 36 weeks of gestational age
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of \< 1500 g.
• Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.

You may not qualify if:

• Newborns who need CPR during the examination.
• Newborns experience apnea during the examination.

Sponsors & Collaborators

• Akdeniz University: lead
• Burdur Mehmet Akif Ersoy University: collaborator

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Eye Pain

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Eye Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Halil I Taşdemir, PhD

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: June 6, 2023
• Primary Completion: July 4, 2023
• Study Completion: July 30, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)