Pain and Comfort in the Examination of Retinopathy of Prematurity

NCT07334652 | Enrolling By Invitation

• 2 other identifiers: B.30.2.ATA.0.01.00/648Ataturk University
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature; Retinopaty of Prematurity

Outcome Measures

Primary Outcomes (1)

• Procedural pain

  Premature Infant Pain Profile - Revision (PIPP-R)

  8-12 week

Secondary Outcomes (1)

• Comfort

  8-12 week

Study Arms (2)

Pacifier group

EXPERIMENTAL

Breast milk and dummy

Other: Pacifier group

Control Group

NO INTERVENTION

Routıne Procedure

Interventions

Pacifier group OTHER

During the examination, babies will be given a dummy dipped in breast milk.

Pacifier group

Eligibility Criteria

• Age: 0 Months - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)