Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-26 @ 10:22 AM
Study NCT ID:
NCT06694103
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
Sponsor:
Sinem Basdemir
Organization:
Study Overview
Official Title:
The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: