search
Back to results

Multisensory Stimulation in Infants for Eye Examination

Primary Purpose

Premature Retinopathy, Pain, Eye

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multisensorial Stimulation
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Retinopathy focused on measuring preterm infants, Multisensorial stimulation

Eligibility Criteria

32 Weeks - 36 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multisensorial Stimulation Group

Control Group

Arm Description

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

Preterm newborns who will receive routine care during the eye examination

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
defines the newborn's heart rates per minutes.
Oksigen saturation
defines the newborn's Oksigen saturation

Full Information

First Posted
March 29, 2023
Last Updated
July 6, 2023
Sponsor
Akdeniz University
Collaborators
Burdur Mehmet Akif Ersoy University
search

1. Study Identification

Unique Protocol Identification Number
NCT05830409
Brief Title
Multisensory Stimulation in Infants for Eye Examination
Official Title
Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
Collaborators
Burdur Mehmet Akif Ersoy University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Retinopathy, Pain, Eye
Keywords
preterm infants, Multisensorial stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multisensorial Stimulation Group
Arm Type
Experimental
Arm Description
Preterm newborns who will receive multisensory stimulation during the eye examination.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Preterm newborns who will receive routine care during the eye examination
Intervention Type
Behavioral
Intervention Name(s)
Multisensorial Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.
Time Frame
first 30 minutes during procedure
Secondary Outcome Measure Information:
Title
Heart rate
Description
defines the newborn's heart rates per minutes.
Time Frame
first 30 minutes during procedure
Title
Oksigen saturation
Description
defines the newborn's Oksigen saturation
Time Frame
first 30 minutes during procedure

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Newborns younger than 36 weeks of gestational age
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halil ibrahim Taşdemir, PhD
Phone
+905443356575
Email
dibrahimtasdemir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz D Taşdemir, RA
Phone
+905378257687
Ext
8254
Email
denizdtasdemir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil I Taşdemir, PhD
Organizational Affiliation
Burdur Mehmet Akif Ersoy University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halil ibrahim RN Taşdemir, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
will be decided later

Learn more about this trial

Multisensory Stimulation in Infants for Eye Examination

We'll reach out to this number within 24 hrs