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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: non-nutritive sucking

• Registration Number: NCT04463927
• Lead Sponsor: Adiyaman University Research Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2020-05-10
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Primary Completion: 2020-08-08
• Study Completion: 2020-10-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-07
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	non-nutritive sucking	The non-nutritive sucking is applied to the group during the examination for retinopathy of prematurity

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile	1 minute	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).

Trial Locations

Locations (1)

Adiyaman University; 🇹🇷 Adiyaman, Turkey