Pain and Comfort in the Examination of Retinopathy of Prematurity

This study is planned to be conducted in the Neonatal Intensive Care Unit using a double-blind, parallel-group, randomised controlled design to determine the effect of a pacifier dipped in breast milk on pain and comfort during Retinopathy of Prematurity examinations. The study will be conducted in the Neonatal Intensive Care Unit of a University Hospital in Erzurum. The sample for the study will consist of preterm infants born before 32 weeks of gestation who are receiving treatment and care at the clinic during the study period and who meet the study criteria, without using any sampling method. The power analysis for sample size indicated that at least 36 infants should be included in the study, with 18 infants in each of the experimental and control groups. The control group will undergo ROP examination in accordance with standard clinical procedures. All examinations will be performed by the same ophthalmologist. Infants in the experimental group will be fed with a pacifier dipped in breast milk, starting two minutes prior to the examination, by the same clinical nurse responsible for the infant's care, and feeding will continue until the examination is completed. Video recordings will be taken of all infants from two minutes prior to the start of the examination until two minutes after the examination. In both groups, data will be monitored and recorded using the Preterm Infant Pain Profile-Revised (PIPP-R), the Preterm Infant Comfort Scale (COMFORT neo), and vital signs before the ROP examination begins, during the examination, and after the examination.

Study Overview

• Status: Enrolling by invitation
• Conditions: Premature; Retinopaty of Prematurity
• Intervention / Treatment: Other: Pacifier group

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yakutiye
    • Erzurum, Yakutiye, Turkey (Türkiye)
      • Ataturk University Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gestational age ≤ 32 weeks
• Birth weight ≤ 2000 grams
• Infants undergoing their first ROP examination
• Spontaneous breathing, not intubated,
• Not receiving sedation
• No congenital defects,
• No unexplained crying,
• No surgical intervention,
• Parents' consent to participate in the study

Exclusion Criteria:

• The presence of a condition that prevents pain assessment (intracranial haemorrhage, neurodevelopmental delay, etc.)
• A different painful procedure performed prior to ROP (one hour)
• Being on mechanical ventilation
• Administration of sedative, analgesic, and anticonvulsant medication prior to examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pacifier group; Breast milk and dummy	Other: Pacifier group; During the examination, babies will be given a dummy dipped in breast milk.
No Intervention: Control Group; Routıne Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural pain	Premature Infant Pain Profile - Revision (PIPP-R)	8-12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Preterm infant comfort scale (COMFORT neo)	8-12 week

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: B.30.2.ATA.0.01.00/648; Ataturk University (Other Identifier: Scientific Research Projects Coordination Centre)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No