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

Recruiting now · Not applicable

Conditions studied: Retinopathy of Prematurity (ROP)

In brief

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.

Key facts

Study ID

NCT06694103

Run by

Sinem Basdemir

People needed

84

Starts

2024-02-19

Expected to finish

2025-07-30

Last updated by the study team

2024-11-19

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital — Izmir, Menemen, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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