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Comparison of reduction of ROP screening-related procedural pain in the conventional method and different KMC positions

Comparison of Efficacy of kangaroo mother care positions with conventional method for reduction of procedural pain associated with ROP screening- a multi-arm randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087298
Enrollment
75
Registered
2025-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: ROP Screening in modified KMC position and Reverse KMC position: Modified KMC position: Mothers will be sitting in specialized chairs of adjustable height. Baby will be wearing cap and

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born at less than 34 weeks gestational age or with birth weight less than 2000 grams if gestational age not known conclusively undergoing ROP screening, after obtaining an informed consent. Repeat ROP screening will be considered as an independent event and will be assessed separately

Exclusion criteria

Exclusion criteria: 1. Neonates who are born with significant congenital malformation, including ocular malformations 2. Babies with hemodynamic instability 3. Babies on invasive mode of ventilation 4. Consent not given by parents

Design outcomes

Primary

MeasureTime frame
Premature infant pain profile -revised(PIPP-R) score will be assessed to evaluate procedural pain 5 minutes before procedure(baseline) During procedure 5 minutes post-procedure Timepoint: Premature infant pain profile score - 5 minutes before procedure(baseline) During procedure 5 minutes post-procedure

Secondary

MeasureTime frame
1. Time taken to complete the screening procedure 2. Adverse physiological event during ROP screening- documenting from multipara monitor 3.Operator satisfaction through questionnaire method 4. Parental satisfaction through 3 point Likert scaleTimepoint: Outcomes will be assessed based on multipara monitor recording during the procedure, duration will be assessed from video recoording of procedure retrospectively, operator & parental satisfaction will be evaluated 5 minutes post-procedure

Countries

India

Contacts

Public ContactDr Nima Sebastian

AIIMS Bhubaneswar

sebastiannima@gmail.com9503979108

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026