Non-drug methods for pain relief during eye exams in premature infants
Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants: A Randomised Controlled Crossover Trial
NA · Istanbul Medeniyet University · NCT06959290
This study is testing different non-drug methods to see if they can help reduce pain for premature infants during eye exams for a condition called retinopathy of prematurity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 26 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Istanbul Medeniyet University (other) |
| Locations | 1 site (İstanbul, İ̇stanbul) |
| Trial ID | NCT06959290 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of various non-pharmacological methods for managing pain in preterm infants undergoing eye examinations for retinopathy of prematurity (ROP). The examination process can cause significant discomfort due to the use of eye drops, speculum placement, and bright lights. The study will monitor the infants' pain levels and vital signs during the examination to assess the impact of these non-drug interventions. By focusing on non-pharmacological approaches, the study seeks to enhance the comfort and emotional experience of these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates include preterm infants with a gestational age of 32 weeks or less or a birth weight of 1500 grams or less, who are stable and undergoing their first ROP examination.
Not a fit: Patients with severe respiratory diseases, critical conditions, or those who have received certain medications within 24 hours prior to the examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve pain management for preterm infants during critical eye examinations.
How similar studies have performed: Previous studies have indicated that non-pharmacological methods can effectively reduce pain in infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
İstanbul, İ̇stanbul
- Istanbul Medeniyet University — İstanbul, İ̇stanbul, Turkey (RECRUITING)
Study contacts
- Study coordinator: Aynur Aytekin Özdemir, PhD
- Email: aynur.ozdemir@medeniyet.edu.tr
- Phone: +902162804104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Infant, Retinopaty of Prematurity, Pain Management, Retinopaty of prematurity examination, Pain management