Actively Recruiting
The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants
Led by Sinem Basdemir · Updated on 2024-11-19
84
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how two different non-drug positioning methods affect pain during retinopathy examinations in premature infants. It focuses on infants born before 34 weeks gestation and compares the reverse kangaroo care position to the standard ROP position. The study seeks to find out if the reverse kangaroo care position reduces pain better than the traditional ROP position during these eye exams. Premature infants will be randomly assigned to one of two groups: the Reverse Kangaroo Care Position group or the ROP Position group. In the reverse kangaroo care group, infants will lie with their back against their mother's bare chest while the mother lies on the examination table. In the ROP position group, infants will lie on their back with support from a nurse and the mother. Both groups will receive topical anesthetic eye drops before the exam, and their oxygen levels and heart rates will be monitored continuously. Video recordings will capture the infants before, during, and after the eye examination. Parents will provide consent before participation, and researchers will fill out forms with infant information. The study team will record pain and physiological measures such as oxygen saturation, heart rate, and the Premature Infant Pain Profile-Revised (PIPP-R) score at specific time points before, during, and after the eye exam. Video recordings will support these assessments. The overall study period includes monitoring for one minute before and after the examination to fully capture the infants' responses to the positioning methods during the retinopathy screening.
CONDITIONS
Brief Title
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age <34 weeks
- Birth weight 64 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants are assigned to either the Reverse Kangaroo Care Position or ROP Position group for the retinopathy examination. The examination involves positioning the infant, applying anesthetic eye drops, monitoring vital signs, video recording before, during, and after the examination, and evaluating pain and oxygen saturation levels.
1 examination visit (in-person)
Trial Site Locations
Total: 1 location
1
Izmır Provincial Health Directorate Bakircay University Cigli Regional Educational Hospital
Izmir, Menemen, Turkey (Türkiye), 35610
Actively Recruiting
Research Team
S
Sinem Başdemir, Research Assistant
S
Sayime Aydın Eroğlu, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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