Multisensory Stimulation in Infants for Eye Examination | NCT05830409

Studies
Multisensory Stimulation in Infants for Eye Examination

NCT05830409

Sponsor

Akdeniz University

Status

Completed

Last Update Posted

Dec 22, 2023Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Premature Retinopathy
Pain, Eye

Interventions

Multisensorial Stimulation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2023Actual

Primary Completion Date

Jul 4, 2023Actual

Completion Date

Jul 30, 2023Actual

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Apr 24, 2023

First Posted Date

Apr 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2023

Last Update Posted Date

Dec 22, 2023Actual

Name	Class
Burdur Mehmet Akif Ersoy University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Newborns younger than 36 weeks of gestational age

Minimum Age

32 Weeks

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Halil I Taşdemir, PhD	Burdur Mehmet Akif Ersoy University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akdeniz University		Antalya			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

will be decided later

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity
D058447	Eye Pain

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases

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Browse Branches

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