Clinical trial NCT06959290: Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants
Official title: Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants: A Randomised Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Infant
Retinopaty of Prematurity
Pain Management
Keywords: Premature Infant
Retinopaty of prematurity examination
Pain management
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 48
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)
timeFrame: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure
measure: Heart rate
timeFrame: 1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medeniyet University
state: İ̇stanbul
Study officials:
affiliation: İstanbul Medeniyet University
name: Aynur Aytekin Ozdemir, Professor
role: STUDY_DIRECTOR
References: