Multisensory Stimulation in Infants for Eye Examination

Sponsor

Akdeniz University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05830409

Collaborator

Burdur Mehmet Akif Ersoy University (Other)

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Retinopathy Pain, Eye	Behavioral: Multisensorial Stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination

Actual Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multisensorial Stimulation Group Preterm newborns who will receive multisensory stimulation during the eye examination.	Behavioral: Multisensorial Stimulation 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.
No Intervention: Control Group Preterm newborns who will receive routine care during the eye examination

Arm

Intervention/Treatment

Experimental: Multisensorial Stimulation Group

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

Behavioral: Multisensorial Stimulation

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.

No Intervention: Control Group

Preterm newborns who will receive routine care during the eye examination

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate [first 30 minutes during procedure]
defines the newborn's heart rates per minutes.
Oksigen saturation [first 30 minutes during procedure]
defines the newborn's Oksigen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akdeniz University	Antalya		Turkey

Sponsors and Collaborators

Akdeniz University
Burdur Mehmet Akif Ersoy University

Investigators

Principal Investigator: Halil I Taşdemir, PhD, Burdur Mehmet Akif Ersoy University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halil Ibrahim Tasdemir, Principal Investigator, Akdeniz University

ClinicalTrials.gov Identifier:

NCT05830409

Other Study ID Numbers:

MAKU23-1

First Posted:

Apr 26, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Halil Ibrahim Tasdemir, Principal Investigator, Akdeniz University

preterm infants

Multisensorial stimulation

Additional relevant MeSH terms:

Retinopathy of Prematurity

Study Results

No Results Posted as of Apr 26, 2023