Evaluating pain relief methods during eye exams for premature infants
The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
This study is testing two different ways to hold premature infants during eye exams to see which one helps reduce their pain better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 28 Weeks to 33 Weeks |
| Sex | All |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir, Menemen) |
| Trial ID | NCT06694103 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two positioning techniques, reverse kangaroo care and standard ROP position, in reducing pain during retinopathy examinations in premature infants. A total of 84 infants with a gestational age of less than 34 weeks will be randomly assigned to one of the two groups. The study will assess pain levels using video recordings and physiological indicators before, during, and after the examination. The goal is to determine which positioning method is more effective in alleviating pain during this critical procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants with a gestational age of less than 34 weeks and a birth weight of 2500 grams or less.
Not a fit: Patients with conditions that prevent pain assessment or those who have undergone painful procedures shortly before the examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for premature infants undergoing eye examinations.
How similar studies have performed: While the specific approach of reverse kangaroo care in this context may be novel, similar non-pharmacological methods have shown promise in managing pain in other pediatric settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age \<34 weeks, * Birth weight ≤ 2500 grams, * No painful interventions at least 1 hour before the ROP examination, * Fed at least 1 hour before the ROP examination, * Premature infants whose parents consented to participate in the study. Exclusion Criteria: * Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.) * Any congenital anomaly (eye, neurological, etc.), * Have a diagnosed hearing problem, * A different painful procedure was performed at least one hour before the ROP examination, * Administration of an analgesic/sedative medication before the examination, * Premature infants whose parents did not consent to participate in the study.
Where this trial is running
Izmir, Menemen
- Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital — Izmir, Menemen, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Hatice Bal Yılmaz, Prof. Dr. — Ege University
- Study coordinator: Sinem Başdemir, Research Assistant
- Email: sinem.basdemir@bakircay.edu.tr
- Phone: +905550074974
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.