The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
ConditionRetinopathy of Prematurity (ROP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-33
SponsorSinem Basdemir
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Reverse Kangaroo Care Position
Other intervention* 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.
ROP Position
Other intervention* 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Reverse Kangaroo Care Position GroupExperimental treatment 1 intervention
Group B: ROP Position GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Premature Introductory Information Form:
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.
Time frame
Pre-intervention2
Premature Infant Follow-up Form
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.
Time frame
15th minute before the examination; 1st minute during the examination, 30 seconds after the examination3
Premature Infant Pain Profile Scale-Revised Form (PIPP-R)
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).
Time frame
15th second before the examination; 1st minute during the examination, 30 seconds after the examinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sinem Basdemir
Lead sponsor
Ege University
Sponsor institution
Source ClinicalTrials.gov