Clinical trial NCT06694103: The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
Official title: The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinopathy of Prematurity (ROP)
Keywords: Premature
Retinopathy Screening
Retinopathy of Prematurity (ROP)
Reverse Kangaroo Care Position
Pain
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 84
Sex: ALL
Minimum age (years): 28
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: * 84 premature infants that meet the sample criteria will be determined.
* Randomization will be performed and premature babies will be assigned to the Reverse Kangaroo Care Position (Group 1) and Rope Position (Group 2) groups.
* The purpose of the study will be explained to the mother by meeting her and written consent will be obtained.
* The Premature Identification Form, which includes information about the infant, will be filled out.

According to the groups to which the premature infants who were randomized were assigned;

One minute before the examination;

1. The infants will be placed on the examination table and one drop of %0.5 alcaine (proparacaine HCl) topical anesthetic eye drops will be applied to both eyes of the premature infantss assigned to both groups by the neonatal intensive care nurse.
2. The pulse oximetry probe will be attached to the infants' right feet and monitored.
3. The infants will be positioned according to the group they are assigned to.
4. Video recording will be started one minute before the examination and will continue until 1 minute after the examination.
5. In order to evaluate the SPO2, KTA, PIPP-R values of all groups at the 15th second before the examination, the infant will be recorded on video for one minute.

During the Examination; In the Reverse Kangaroo Care Position Group;

1. While the reverse kangaroo care position applied to the infants is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
2. The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation

In the ROP Position Group;

1. While the ROP position applied to the babies is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
2. The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation

At the end of the examination;

1. After the completion of both eye examinations, the video recording will continue for 1 more minute while the positions of the babies whose monitoring continues are maintained
2. The video recording will end 1 minute after the examination ends
3. The infant's SPO2, KTA, values, PIPP-R pain score will be evaluated and recorded
4. . The aim is to record the infant's SPO2 and KTA values at 30 seconds so that the PIPP-R pain score can be evaluated later.

Eligibility 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.

Primary outcomes:
measure: Premature Introductory Information Form:
timeFrame: Pre-intervention
measure: Premature Infant Follow-up Form
timeFrame: 15th minute before the examination; 1st minute during the examination, 30 seconds after the examination
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
state: Menemen
Study officials:
affiliation: Ege University
name: Hatice Bal Yılmaz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: