RecruitingNot Applicable

The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination

Turkey (Türkiye)84 participantsStarted 2024-02-19

Plain-language summary

The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows: 1. Is the reverse kangaroo care position effective in reducing the pain of premature infants during the ROP examination? 2. Is the reverse kangaroo care position more effective in reducing the pain of premature infants compared to the ROP position during the ROP examination? Researchers will determine the effect of reverse kangaroo care position and ROP position applied during premature retinopathy examination in premature infants with a gestational age of less than 34 weeks on pain in infants. * The infants of parents who volunteer to participate in the study will be divided into two groups as Reverse Kangaroo Care Position group and ROP Position group according to randomization. * From the infants whose pupils are sufficiently mydriasis and are taken to the examination table, premature infants in the ROP Position group will be given ROP position together with the nurse and the parent. * Premature infants in the Reverse Kangaroo Care Position group will be given reverse kangaroo care position. * Video recording will be made during the given positions. * The effects of the applied positions on pain will be determined as a result of the measured parameters before, during and after the examination.

Who can participate

Age range

28 Weeks – 33 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Premature Introductory Information Form:

Timeframe: Pre-intervention

Premature Infant Follow-up Form

Timeframe: 15th minute before the examination; 1st minute during the examination, 30 seconds after the examination

Premature Infant Pain Profile Scale-Revised Form (PIPP-R)

Timeframe: 15th second before the examination; 1st minute during the examination, 30 seconds after the examination

Trial details

NCT IDNCT06694103

SponsorSinem Basdemir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Sinem Başdemir, Research Assistant

+905550074974 sinem.basdemir@bakircay.edu.tr

View on ClinicalTrials.gov More Retinopathy of Prematurity (ROP) trials