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CTRI Number  CTRI/2025/08/093840 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Multimodal Sensory stimulation]  
Study Design  Other 
Public Title of Study   Impact of graded stimulation of various sensory system by Family and Occupational therapists on agitation and consciousness in patients after Brain Surgery. 
Scientific Title of Study   The Effect of graded sensory stimulation by family members on agitation level and graded multimodal sensory stimulation by therapist on level of consciousness in patients with Glasgow coma score greater then or equal 8, following neurosurgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Palsambkar 
Designation  Post Graduate student in Occupational therapy 
Affiliation  OT Training School and Center LTMMC and GH 
Address  5th Floor MRO building Occupational therapy training school and center, Lokmanya Tilak Municipal Medical College and General Hospital , Laxmibai Kelkar road, Sion east, Mumbai 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  8779978409  
Fax    
Email  sakshipalsambkar346@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuradha Pai 
Designation  Asst Professor 
Affiliation  OT Training School and Center LTMMC and GH 
Address  5th Floor MRO building Occupational therapy training school and center, Lokmanya Tilak Municipal Medical College and General Hospital , Laxmibai Kelkar road, Sion east, Mumbai 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9820661856  
Fax    
Email  suchanu@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuradha Pai 
Designation  Asst Professor 
Affiliation  OT Training School and Center LTMMC and GH 
Address  5th Floor MRO building Occupational therapy training school and center, Lokmanya Tilak Municipal Medical College and General Hospital , Laxmibai Kelkar road, Sion east, Mumbai 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9820661856  
Fax    
Email  suchanu@rediffmail.com  
 
Source of Monetary or Material Support  
Occupational therapy School and center Lokmanya Tilak Municipal Medical College Sion Mumbai 
 
Primary Sponsor  
Name  Occupational therapy School and center Lokmanya Tilak Municipal Medical College Sion Mumbai 
Address  Lokmanya Tilak Municipal Medical College Sion Mumbai 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Palsambkar  Lokmanya Tilak Municipal Medical College and General Hospital   5th Floor MRO building Occupational therapy training school and center, Lokmanya Tilak Municipal Medical College and General Hospital , Laxmibai Kelkar road, Sion east, Mumbai 400022 India
Mumbai
MAHARASHTRA 		 8779978409

sakshipalsambkar346@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research,Lokmanya Tilak Municipal Medical College and General Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R451||Restlessness and agitation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Occupational Therapy  Patients in the control group will receive conventional occupational therapy for 18 days divided into 3 phases which will include general awakening, Positioning and splintage, tone normalization, passive ROM exercises and in bed mobility.  
Intervention  Multimodal sensory stimulation  Patients in the interventional group will receive 18 days protocol divided into 3 phase. Phase 1 will involve sensory stimulation by family members and its effect on level of agitation. Phase 2 will involve use of multimodal sensory stimulation by therapist and its effect on level of agitation and consciousness. Phase 3 will be similar to phase 2 and will continue until discharge or day 18.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  For patients
Age 18 to 65 years
An agitation rate of plus 2 to plus 4 based on the Richmond Agitation and Sedation Scale
Glasgow coma score less than or equal to 8
Patients post first time neurosurgery for Subarachnoid haemorrhage , Space occupied lesion and craniotomy.
24 to 48 hours of stabilization of hemodynamic symptoms.
For family members
Being an adult primary caregiver of the patients own family like father, mother, sibling, spouse, child and grandchild.
The regular presence of the selected family member during the intervention
 
 
ExclusionCriteria 
Details  Hemodynamic instability in patients during the intervention after recruitment into the study
Requirement of emergency surgery due to increased intracranial pressure
Presence of diagnosed hearing impairment or skin disorder in the area of tactile stimulation prior to surgery.
Patients attended by a paid caregiver.
 
 
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 
Level of Agitation will be assessed using Richmond agitation- sedation scale ( RASS)
Level of consciousness will be assessed Coma recovery scale- revised and Glasgow coma scale
Caregiver burden will be assesed using Zarit Caregiver burden scale
 		 Richmond agitation- sedation scale and Glasgow coma scale will be used as screening tool. Richmond agitation- sedation scale, Coma recovery scale and Zarit caregiver burden scale will be assessed on Day 1,7,12,18 or at discharge.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The study will adopt a quasi-experimental prospective design , recruiting 42 post-neurosurgery patients with a Glasgow Coma Score (GCS) less than or equal to 8. Participants will be allocated into experimental and control groups through blocked randomization. The intervention will extend over 18 consecutive days and will be carried out in three structured phases. In the first phase, trained family members will provide graded tactile and auditory stimulation, under the supervision of the researcher. In the subsequent phases, therapists will introduce graded multimodal sensory stimulation, which will include auditory, tactile, olfactory, visual, and kinesthetic. Each stimulation session will last about 45 minutes daily, with consistent monitoring. Patients in the control group will receive only routine interactions without structured sensory input. Outcomes will be assessed at pre-, mid-, and post-intervention stages using the Richmond Agitation-Sedation Scale (RASS) for agitation, the Coma Recovery Scale-Revised (CRS-R) for consciousness, and the Zarit Caregiver Burden Scale for caregiver burden. Data will then be statistically analyzed. 
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