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

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.

Conditions

• Retinopathy of Prematurity (ROP)

Interventions

OTHER

Reverse Kangaroo Care Position

* Babies will be taken to the examination table and their clothes other than diapers will be removed. * Mothers will take off their upper clothes and lie on the examination table and position their babies in the reverse kangaroo care position, with the baby's back against the mother's bare chest. * Babies will be monitored with disposable probes from their right feet. * Video recording will be started. -While the position applied to the babies is maintained, the speculum will be placed in the eye by the ophthalmologist and the examination will be recorded on video from the beginning to end. * After the completion of both eye examinations, the position of the babies whose monitoring continues will be maintained while the video recording will be taken for another 1 minute. The SPO2, HR, PIPP-R score at the end of the 15th second before the examination, the first minute during the examination and the 30th second after the examination will be evaluated.

OTHER

ROP Position

* Babies will be taken to the examination table and monitored with disposable probes from their right feet. * The nurse will place the infant's own palms on the temporal region and hold them with her hands to support their head, while the mother will also support the infant by holding their legs. * The video recording will be started. * SPO2, HR, PIPP-R values will be recorded on video for one minute. * While the ROP position applied to the babies is maintained, the speculum is placed in the eye by the ophthalmologist and the examination begins. * SPO2, HR, PIPP-R evaluation at the 1st minute of the examination. * After the completion of both eye examinations, the babies whose monitoring continues will be kept in their positions and a video recording will be taken for another 1 minute. * The SPO2, HR values and PIPP-R pain score at the end of the 30 seconds after the examination will be evaluated.

Sponsors & Collaborators

• Sinem Basdemir

  lead OTHER

Principal Investigators

• Hatice Bal Yılmaz, Prof. Dr. · Ege University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

28 Weeks

Max Age

33 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-19

Primary Completion

2025-06-30

Completion

2025-07-30

Countries

• Turkey (Türkiye)

Study Locations