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NCT04463927 Clinical Trial

The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Pain Clinical Trial

Official title:
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04463927
Other study ID # 2020/2-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2020
Est. completion date October 9, 2020

Study information
Verified date August 2021
Source Adiyaman University Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

Description:

A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 9, 2020
Est. primary completion date August 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 28 Weeks to 36 Weeks
Eligibility Inclusion Criteria: - having an examination for retinopathy of prematurity for the first time, - age was between 28-35 weeks Exclusion Criteria: - having no congenital anomalies

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• non-nutritive sucking
intervention group received a sterile gloved finger during the examination for retinopathy of prematurity

Locations
Country Name City State
Turkey Adiyaman University Adiyaman

Sponsors (1)
Lead Sponsor Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Premature Infant Pain Profile The primary outcome of the study is to evaluate the pain relief efficacy of non-nutritive sucking during examination for retinopathy of prematurity Premature Infant Pain Profile (PIPP). 1 minute
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