Actively Recruiting

Phase Not Applicable
Age: 28Weeks - 33Weeks
All Genders
Healthy Volunteers
NCT06694103

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

Led by Sinem Basdemir · Updated on 2024-11-19

84

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 28Weeks - 33Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age less than 34 weeks
  • Birth weight 2500 grams or less
  • No painful interventions at least 1 hour before the ROP examination
  • Fed at least 1 hour before the ROP examination
  • Parents have given consent for the infant to participate
Not Eligible

You will not qualify if you...

  • Conditions preventing pain assessment such as intracranial hemorrhage or neuromotor developmental delay
  • Any congenital anomaly including eye or neurological issues
  • Diagnosed hearing problems
  • Painful procedures performed within 1 hour before the ROP examination
  • Use of analgesic or sedative medication before the examination
  • Parents did not consent to participation

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Trial Site Locations

Total: 1 location

1

Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital

Izmir, Menemen, Turkey (Türkiye), 35610

Actively Recruiting

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Research Team

S

Sinem Başdemir, Research Assistant

CONTACT

S

Sayime Aydın Eroğlu, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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