Multisensory Stimulation in Infants for Eye Examination

Not Applicable

Completed

• Conditions: Premature Retinopathy; Pain, Eye
• Interventions: Behavioral: Multisensorial Stimulation

• Registration Number: NCT05830409
• Lead Sponsor: Akdeniz University

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.

Detailed Description

Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-26
• Study Start: 2023-06-06
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multisensorial Stimulation Group	Multisensorial Stimulation	Preterm newborns who will receive multisensory stimulation during the eye examination.

Primary Outcome Measures

Name	Time	Method
Pain level	first 30 minutes during procedure	Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.

Secondary Outcome Measures

Name	Time	Method
Oksigen saturation	first 30 minutes during procedure	defines the newborn's Oksigen saturation
Heart rate	first 30 minutes during procedure	defines the newborn's heart rates per minutes.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey