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

NCT06959290 | Completed

• 1 other identifier: 01.11.2024/21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature Infant; Retinopaty of prematurity examination; Pain management

Outcome Measures

Primary Outcomes (1)

• Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)

  The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of \<7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.

  1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure

Secondary Outcomes (2)

• Oxygen saturation

  1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure

• Heart rate

  1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure

Study Arms (2)

Control Group

SHAM COMPARATOR

Retinopathy of prematurity examination will be performed according to clinical routine practice.

Other: Routine Treatment

Intervention Group

ACTIVE COMPARATOR

Multiple nonpharmacological methods will be applied for pain management during retinopathy of prematurity examination.

Procedure: Multiple nonpharmacological methods

Interventions

Multiple nonpharmacological methods PROCEDURE

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.

Intervention Group

Routine Treatment OTHER

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.

Control Group

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
• Stable, awake, in supine position and breathing spontaneously without oxygen support,
• Vital signs were within normal limits before the examination,
• Premature infants undergoing ROP examination for the first time.

You may not qualify if:

• Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
• Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
• Preterms with critical conditions such as central nervous system infections and sepsis,
• Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
• Preterms with congenital malformations.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Istanbul, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Agnosia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Aytekin Ozdemir, Professor

  İstanbul Medeniyet University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July through December of 2026
• Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Locations

TU (1)