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Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants

NCT06959290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-14

No results posted yet for this study

Summary

This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).

Conditions

  • Premature Infant
  • Retinopaty of Prematurity
  • Pain Management

Interventions

PROCEDURE

Multiple nonpharmacological methods

The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. The nurse will then give the baby 25% dextrose solution orally (0.5ml for those \<32 weeks gestation, 1ml for those \>32 weeks gestation). The nurse then places a pacifier soaked in 25% dextrose solution in the preterm infant's mouth. After these three non-pharmacological methods, the doctor will perform the ROP examination.

OTHER

Routine Treatment

The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. After these three non-pharmacological methods, the doctor will perform the ROP examination.

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Aynur Aytekin Ozdemir, Professor · İstanbul Medeniyet University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
26 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-06-30
Completion
2025-06-30

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 NCT06959290 on ClinicalTrials.gov