| CTRI Number |
CTRI/2025/09/095009 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing Pain in Premature Babies Through Gentle Multisensory Care |
Scientific Title of Study
Modification(s)
|
Multi-modal stimulation to minimize procedural pain in extremely and very preterm neonates undergoing
retinopathy of prematurity: A randomized controlled trial |
| Trial Acronym |
MMS to minimize pain in preterm undergoing ROP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunima Anilkumar |
| Designation |
PG Student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Room No 302
3rd Floor
Department of Physiotherapy Yenepoya Physiotherapy College
Naringana Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6238797875 |
| Fax |
|
| Email |
35946@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Asir John Samuel |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Room No 302
3rd Floor
Department of Physiotherapy Yenepoya Physiotherapy College
Naringana Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8059930222 |
| Fax |
|
| Email |
asirjohnsamuel@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Bappal |
| Designation |
Professor |
| Affiliation |
Yenepoya Medical College |
| Address |
Room No. 502
5th Floor
Department of Ophthalmology Yenepoya Medical College, Deralakatte, Mangalore
Mangalore
Dakshina Kannada
KARNATAKA
5750185
India |
| Phone |
9448388924 |
| Fax |
|
| Email |
dranupamabappal@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College |
|
|
Primary Sponsor
|
| Name |
Arunima Anilkumar |
| Address |
Yenepoya Physiotherapy College
Yenepoya deemed to be university
Mangalore 575018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arunima Anilkumar |
Yenepoya Medical College Hospital |
NICU Department,
Paediatrics
Yenepoya Medical College
University Road Deralakatte Mangalore 575018
Dakshina Kannada
KARNATAKA |
6238797875
35946@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi modal stimulation |
Visual: For around three minutes, maintain eye contact with the newborn.
Auditory: The therapist should speak softly and steadily to the infant. for three minutes
Olfactory: Vanilla essence is diluted in five milliliters of water and allowed to smell for three minutes from a distance of one to two centimeters.
The mothers milk will be extracted from an injector and placed in the newborns mouth for a 30-second sucking session.
Tactile: Help the newborn feel at ease and relaxed
Three primary methods of manipulation are done:
1.EFFLEURAGE
i. Stroking
2.PETRISSAGE
I. Kneading
a) Flat finger kneading
Effleurage
b) Finger pad kneading
Effleurage
ii. Wringing
Effleurage
iii.Plucking
Effleurage
iii.Tapping
Effleurage
|
| Comparator Agent |
Standard NICU care |
Non pharmacological methods like swaddling and non-nutritive sucking |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Weight of Less than 1500 grams
Gestational age of 28 to 32 weeks
Stable neonates
Not fed in last 1 hour
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PIPP-R (premature infant pain profile revised) |
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 Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2025 |
| Date of Study Completion (India) |
27/06/2026 |
| Date of First Enrollment (Global) |
29/09/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Various nonpharmacological interventions have been used to reduce pain in extremely and very preterm neonates undergoing retinopathy of prematurity. This study will be focusing on Multi modal stimulation to reduce pain in preterm infants undergoing ROP. The participants between 28 -32 weeks of gestational age are included in this study.
- Pre-Screening. ROP screening, visual stimulation, auditory stimulation, olfactory stimulation, taste stimulation, and tactile stimulation are given.
- PIPP-R scores are measured before, during, and after the procedure.
|