| CTRI Number |
CTRI/2024/03/063565 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Exercises, Breathing Techniques, Meditation, Psychoeducation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Multimodal Intervention on mental fatigue among elderly.
|
|
Scientific Title of Study
|
Effect of multimodal intervention on mental fatigue among elderly people residing in community area, Bhubaneswar Odisha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deblina Nandi |
| Designation |
Master Student |
| Affiliation |
Kalinga Institute of Nursing sciences |
| Address |
Kalinga Institute Of Nursing Sciences
KIIT University
campus 5
Chandaka industrial Estate Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7019294482 |
| Fax |
|
| Email |
2288011@kins.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivasankari Varadharasu |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Nursing sciences |
| Address |
Kalinga Institute Of Nursing Sciences
KIIT University
campus 5
Chandaka industrial Estate Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8144377798 |
| Fax |
|
| Email |
sivrajofficial@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivasankari Varadharasu |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Nursing sciences |
| Address |
Kalinga Institute Of Nursing Sciences
KIIT University
campus 5
Chandaka industrial Estate Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8144377798 |
| Fax |
|
| Email |
sivrajofficial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Nursing Sciences |
|
|
Primary Sponsor
|
| Name |
Deblina nandi |
| Address |
Kalinga institute Of nursing sciences |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siva sankari Varadharasu |
Niladri Vihar |
Niladri Vihar
Chandrasekharpur
ward number 14
751021
Khordha
ORISSA |
8144377798
sivrajofficial@gmail.com |
| Dr Siva sankari Varadharasu |
Niladri Vihar |
chandrashekharpur
bhubaneswar
Khordha
ORISSA |
8144377798
sivrajofficial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kalinga Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mentally Fatigued |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health education |
On day one of the intervention control group will be provided with Health education, Firstly what is mental fatigue and how does it affect life? Rest which will cover the topic of physical exercise and breathing techniques benefits. |
| Intervention |
Multimodal Intervention |
The intervention consisted of Physical Exercises, Breathing Techniques, R.A.I.N Meditation, and Psychoeducation on lifestyle modification. The intervention will be given for a total of 14 days which is of a total 8 sessions, and follow-up for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
Elderly who are willing to participate
Elderly people of the age group of 65-79
Understands Odia /English/ Hindi
|
|
| ExclusionCriteria |
| Details |
Elderly people will not complete the intervention
Those who are physically debilitated.
Diagnosed with acute and chronic mental disorders.
Having any chronic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of multimodal techniques on mental fatigue among elderly residing in community area. |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between mental fatigue & selected socio-demographic variables among elderly residing in community areas. |
8weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="0"
Months="2"
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
|
Mental fatigue is a state
of mental exhaustion assessed through the Self Structured Mental Fatigue Scale.
The elderly people residing in the community can be mentally fatigued. Elderly
aging from 65 years to 79 years will be included. A sample size of this study is 90.
Sampling will be done by systematic random sampling and the design of the study
is true experimental. Firstly, the data is collected from the
individuals with the help of ASHA workers then samples which is meeting the
inclusion criteria, and give consent will be selected, and a pre-test will be
done. The screening tool is the same as the data collection tool, i.e., the Self-Structured Mental Fatigue Scale. To reduce mental fatigue, multimodal
intervention is to be given for 15 days and follow-up is done for 6 weeks, and
then a post-test will be done. The intervention, includes relaxation techniques (physical exercises and breathing techniques),
meditation (mindfulness RAIN Meditation), and psychoeducation. Where the
experimental group will be getting the intervention and on the other hand, the
control group will continue with their daily routine. This study will evaluate the effect of
multimodal techniques on mental fatigue among elderly residing in community areas. |