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

Primary Purpose

Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

non-nutritive sucking

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

28 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Adiyaman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

The non-nutritive sucking is not applied to the control group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04463927

First Posted

July 1, 2020

Last Updated

August 7, 2021

Sponsor

Adiyaman University Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04463927

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

May 10, 2020 (Actual)

Primary Completion Date

August 8, 2020 (Actual)

Study Completion Date

October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Adiyaman University Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

The non-nutritive sucking is not applied to the control group.

Intervention Type

Other

Intervention Name(s)

non-nutritive sucking

Intervention Description

intervention group received a sterile gloved finger during the examination for retinopathy of prematurity

Primary Outcome Measure Information:

Title

Premature Infant Pain Profile

Description

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).

Time Frame

1 minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Weeks

Maximum Age & Unit of Time

36 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuba KOÇ ÖZKAN

Organizational Affiliation

Adiyaman University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adiyaman University

City

Adiyaman

ZIP/Postal Code

02100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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