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Reducing Pain in Premature Babies Through Gentle Multisensory Care

Multi-modal stimulation to minimize procedural pain in extremely and very preterm neonates undergoing retinopathy of prematurity: A randomized controlled trial - MMS to minimize pain in preterm undergoing ROP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095009
Enrollment
24
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Multi modal stimulation: Visual Eye contact is to be made with the newborn s attention by black and white checked square towards the therapist. 3mins Auditory -The therapist should eng
above and below the ear towards the chin using full hand
nose to the ear using finger tips to full hand
midline of the forehead and curves downwards to the ear using the full hand.) 2.PETRISSAGE I. Kneading a) Flat finger kneading 1min -4moves (from chin to cheeks
then chin to ear line using two distal phalanges
upper lip to ear line
nose to ear line
on the forehead) Effleurage is done 30sec -6 moves b) Finger pad kneading 1 min -4 moves (from chin to cheeks
then chin to ear line using the two distal phalanges
upper lip to the ear line
on the forehead) Effleurage is done 30sec -6 moves d)Thumb pad kneading 1 min-4 moves (from chin to cheeks
on the forehead) Effleurage is done 30sec -6 moves ii. Wringing 1 min -4 moves (starts at corner of the mouth and work towards the ear and then crosses the chin to the other ear
again, back to towards mouth, out to the ear from the nose on one cheek and across then forehead i

Sponsors

Arunima Anilkumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Weight of Less than 1500 grams Gestational age of 28 to 32 weeks Stable neonates Not fed in last 1 hour

Exclusion criteria

Exclusion criteria: Any congenital malformations Any congenital infections Babies who are undergoing any corrective surgeries Having any food prohibition Any other neurological conditions History of cardio pulmonary resuscitation or surgery or intraventricular hemorrhage or sedation in last 24 hours Babies requiring positive pressure ventilation Connection to an endotracheal tube

Design outcomes

Primary

MeasureTime frame
PIPP-R (premature infant pain profile revised)Timepoint: 7 times T0 (30 sec before MMS) T1 (30 sec after MMS) T2 (60 sec during ROP examination) T3 (post 30 sec after ROP examination) T4 (post 60 sec after ROP examination) T5 (90 sec after ROP examination) T6 (post 120 sec after ROP examination)—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactAnupama Bappal

Yenepoya Physiotherapy College

asirjohnsamuel@yenepoya.edu.in8059930222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026