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

NCT ID: NCT06959290

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-06-30

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).

Detailed Description

Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the application of eye drops, the placement of the speculum in the eye, the pressure applied to the pupils and the brightness of the ophthalmoscope. Studies in the literature have also reported that newborns experience pain and discomfort during ROP examination. In relation to the ROP pain experienced by the preterm infant, various physiological changes such as increased heart rate or decreased oxygen saturation are experienced during or after the examination. Accordingly, ROP examination is important; however, controlling the pain that occurs during the examination is also very important in terms of the patient's emotional experience and comfort. In the literature, many studies have been conducted to reduce pain during ROP examination. Although pharmacological treatment methods are an effective technique to reduce pain, it is recommended that nonpharmacological methods should be used especially in infants and children because of the side effects of drugs (such as apnoea, bradycardia, respiratory depression, hypotension) and the method to be used should be easy, fast and does not require preparation. The Turkish Neonatology Society and the Turkish Ophthalmology Society also recommend that ROP examination is a very painful procedure, that pharmacological methods alone are not sufficient to reduce pain, and that nonpharmacological methods such as pacifier, breast milk and oral sucrose should be used during the examination. In addition, although there is no gold standard for pain relief during ROP examination, previous studies suggest that clinicians should use more than one method together to reduce pain and provide relief in premature infants. In this study, a combination of oral 25% dextrose, non-nutritive sucking and swaddling will be used for multiple nonpharmacological applications

Conditions

Premature Infant; Retinopaty of Prematurity; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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

Group Type: SHAM_COMPARATOR

Routine Treatment

Intervention Type: 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.

Intervention Group

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

Group Type: ACTIVE_COMPARATOR

Multiple nonpharmacological methods

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Aynur Aytekin Ozdemir

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aynur Aytekin Ozdemir, Professor

Role: STUDY_DIRECTOR

İstanbul Medeniyet University

Locations

Istanbul Medeniyet University

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

01.11.2024/21

Identifier Type: -

Identifier Source: org_study_id