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Pain and Comfort in the Examination of Retinopathy of Prematurity

NCT07334652 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

OTHER

Pacifier group

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

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-30
Completion
2026-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334652 on ClinicalTrials.gov