| CTRI Number |
CTRI/2025/07/090351 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupatinal Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Peaceful Approach: How Multi-Sensory Activities Help Calm Dementia Symptoms |
|
Scientific Title of Study
|
EFFECTIVENESS OF MULTI-SENSORY INTERVENTION(MSI) ON AGITATION AMONG OLDER ADULTS WITH DEMENTIA
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nahila |
| Designation |
student |
| Affiliation |
Chettinad School of Occupational Therapy |
| Address |
Masters of Occupational Therapy- Neurology, Chettinad School of Occupational Therapy department, 4th floor, A block, Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
7034124514 |
| Fax |
|
| Email |
nahilashihaab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pankaj Kumar |
| Designation |
Professor and dean |
| Affiliation |
|
| Address |
Dean Office,
Chettinad School of Occupational Therapy, Chettinad Hospital and Research Institute,Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
9910410156 |
| Fax |
|
| Email |
pankajphdot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nahila |
| Designation |
student |
| Affiliation |
Chettinad School of Occupational Therapy |
| Address |
Masters of Occupational Therapy-Neurology, Chettinad School of Occupational Therapy department, Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
7034124514 |
| Fax |
|
| Email |
nahilashihaab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Masters of occupational Therapy-Neurology, Chettinad School of Occupational Therapy department, 4th floor, A block,Chettinad Academy of Research and Education, Chettinad Health City,Rajuv Gandhi salai (OMR) Kelambakkam, Tamil Nadu , India, 603103 |
|
|
Primary Sponsor
|
| Name |
Nahila |
| Address |
Masters of Occupational Therapy- Neurology, Chettinad School of Occupational Therapy department, 4th floor, A block,Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu, India, 603103 |
| 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 |
| Dr Nahila |
Chettinad Hospital and Research Institute |
Masters of Occupational Therapy- Neurology, Chettinad School of Occupational Therapy department, 4th floor, A block, Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu, India, 603103
Chennai
TAMIL NADU |
7034124514
nahilashihaab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for student Research (CARE IHEC -1) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F039||Unspecified dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cohen Mansfield Agitation Inventory (CMAI) |
At the beginning and followed by 4 weeks of intervention completion agitation will be assessed using CMAI test. |
| Intervention |
Multi-sensory intervention |
Multisensory intervention based on auditory and visual activities to be given. Researcher will provide intervention for 3 day per week for 4 weeks. Total of 12 sessions with each session of 30 minutes will be given. The each intervention session duration will be 30 minutes. The total duration of intervention during study will be 6 hours |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Older adults aged greater than 60 years.
Diagnosed with dementia
Exhibiting measurable agitation.
Ability to perceive auditory and visual stimuli (i.e., no severe deafness or blindness |
|
| ExclusionCriteria |
| Details |
People undiagnosed with dementia
Age below 65 years
Severe psychiatric illness (e.g., active schizophrenia).
Severe sensory impairments (total deafness/blindness).
Terminal illness or unstable medical condition.
Non-consent or inability to participate in intervention
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cohen-Mansfield agitation inventory (CMAI) |
At baseline and after completion of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cohen Mansfield Agitation Inventory (CMAI) |
At 2nd & 3rd week of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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
|
Dementia is a clinical syndrome with a
number of different causes which is characterized by deteroriation in
cognitive, behavioral, social and emotional functions (van der Steen, J. T., van Soest-Poortvliet, M.
C., van der Wouden, J.
C., Bruinsma, M.
S., Scholten, R.
J., & Vink, A.
C. (2017). Agitation in
persons with dementia is a major indication of discomfort and it is a source of
stress for family members and for formal caregivers(Cohen-Mansfield, J., & Libin, A.
(2004). To mitigate agitated and aggressive
behaviors associated with dementia, many healthcare practitioners have
prescribed pharmacological measures, such as anti-psychotic and benzodiazpine
medications. These drugs have been found to be of limited effectiveness and
have adverse side effects (Rados, R.,
Kim, J., Kono, S.,
& Horton, J. (2021). ).
Music or auditory intervention promotes overall wellness not only
mentally but also physically. Stress which is a mental state can be managed
with music intervention as well as physical pain being alleviated. However it
is also found music or auditory intervention helps address cognitive and
behavioral issues (Trainor H.
(2019). Nature is an
important part of the human experience and is associated with psychological
healing properties, such as a sense of renewal.
Nature-based activities, such as walking in nature, participating in
horticulture, as well as viewing simulated nature (e.g., video or photographs),
have appeared to improve the mood and reduce agitation for residents with
dementia receiving long-term care. (Rados, R.,
Kim, J., Kono, S.,
& Horton, J. (2021). ‘Little
empirical
research has been done on which combinations of musical sounds and aesthetic
natural image. However,
given the positive impact of both music and nature-based activities for
individuals with dementia, several studies have attempted to combine these two
modalities to create a combined effect, which is the approach we took in the
current study. (Rados, R.,
Kim, J., Kono, S.,
& Horton, J. (2021).
|