Multisensory Stimulation in Infants for Eye Examination

December 21, 2023 updated by: Halil Ibrahim Tasdemir, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: first 30 minutes during procedure
Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.
first 30 minutes during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: first 30 minutes during procedure
defines the newborn's heart rates per minutes.
first 30 minutes during procedure
Oksigen saturation
Time Frame: first 30 minutes during procedure
defines the newborn's Oksigen saturation
first 30 minutes during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Collaborators

Burdur Mehmet Akif Ersoy University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

July 4, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAKU23-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

will be decided later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Retinopathy

Clinical Trials on Multisensorial Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe