The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
- Conditions
- Retinopathy of Prematurity (ROP)
- Registration Number
- NCT06694103
- Lead Sponsor
- Sinem Basdemir
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Premature Introductory Information Form: Pre-intervention It was prepared by the researcher to determine the characteristics of the premature babies participating in the study. It consists of seven questions including the baby's gender, gestational week, birth weight, postnatal week, delivery method, birth head circumference and height measurement.
Premature Infant Follow-up Form 15th minute before the examination; 1st minute during the examination, 30 seconds after the examination It consists of fields including the premature infant's heart rate, oxygen saturation values and PIPP-R score at the 15th second before the examination, the 1st minute during the examination and the 30 seconds after the examination.
Premature Infant Pain Profile Scale-Revised Form (PIPP-R) 15th second before the examination; 1st minute during the examination, 30 seconds after the examination It is a Likert-type scale. In the scoring of the scale, items related to physiological and behavioral indicators are scored as 0, 1, 2 and 3 points for each variable. Items related to contextual indicators (behavioral status and gestational age) are scored as 3, 2, 1 and 0 points at the beginning of the pain assessment (before contact with the baby). According to PIPP-R, the infant's pain is evaluated based on the total score. In scoring the PIPP-R, behavioral and physiological indicators are scored at the end of the scale. Accordingly, if the infant receives a zero score (subtotal) from the general physiological and behavioral indicators, the contextual indicators are not scored. If the infant receives a score above zero from the initial parameters, the total score is obtained by including the contextual indicators in the scoring. The highest score of the PIPP-R is 21 for preterm infants and 18 for term infants (Stevens et al., 2014).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
🇹🇷İ̇zmi̇r, Menemen, Turkey