| CTRI Number |
CTRI/2025/10/095755 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
An intervention program on Mobile Health Integrated Resilience Building Program among Special School Teachers in selected Districts of Karnataka. |
|
Scientific Title of Study
|
Effectiveness of Mobile Health (mHealth) Integrated Resilience Building Program (mHealth - IRBP) on Occupational Stress, Coping Strategies, Resilience, Quality of Life among Special School Teachers in selected Districts of Karnataka - A Cluster Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rintu Thomas |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Child Health Nursing
Manipal College of Nursing,
Manipal Academy of Higher Education (MAHE), Manipal
Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8156885220 |
| Fax |
|
| Email |
rintuthomas8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrE Binu Margaret |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Child Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education (MAHE) Manipal
Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetha T S |
| Designation |
Associate Professor & HOD |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education (MAHE) Manipal
Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India -576104 |
|
|
Primary Sponsor
|
| Name |
Rintu Thomas |
| Address |
Department of Child Health Nursing, 5th floor, PhD Scholar Room, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka,India-576104 |
| 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 |
| Rintu Thomas |
Manipal College of Nursing |
Department of Child Health Nursing,5th floor, PhD Scholar Room, Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA |
8156885220
rintuthomas8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Occupational stress, coping strategies, resilience and quality of life of special school teachers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Awareness program on stress management |
Baseline assessment or pretest will be done for the control group using the research tools. After the implementation of the intervention for the intervention group, follow up will be done for the control group also for the first, third and sixth month. Then, an awareness program for the control group will be conducted after the last follow up using appropriate AV Aids such as pamphlets, videos and PPTs. The awareness will mainly focus on the understanding and managing stress, its types, common sources, coping strategies, strategies to deal with students, work-life balance and stress management techniques. It will be a one day session with maximum duration of three hours. |
| Intervention |
Mobile Health (mHealth) Integrated Resilience Building Program (mHealth-IRBP) |
The intervention group in the present study will receive the Mobile Health (mHealth) Integrated Resilience Building Program (mHealth-IRBP), which will be administered by the researcher. On day 1, Pre-test will be conducted using the research tools. Once the pretest is done, Mobile Health (mHealth) Integrated Resilience Building Program (mHealth- IRBP) will be conducted for the interventional group. The intervention program will consist of education session, mindfulness session, physical activities, relaxation techniques and mobile technology for providing a comprehensive outcome for the study. It is a comprehensive educational- behavioural interventional program, which integrates school as well as home practices through mobile health technology (blended the educational program by including mobile technology) to reduce the occupational stress, strengthen the coping strategies , improve resilience level and to enhance the quality of life of special school teachers. The intervention will be implemented in a separate room in a consistent manner in small groups in four sessions (weekly once for four weeks) with a maximum total duration of two hours. The program includes disseminating information through activity-based modules integrated with mobile health technology incorporating information materials (Time management, problem solving skills), videos (healthy lifestyle practices), pamphlets (strategies for good communication). Counselling is planned with the help of professional expert, if participants are found to be extremely stressed in both groups and if professional help is required. A fixed follow up duration will be maintained for follow up in the study. The follow up will be done in one, three and 6th month. Confidentiality and anonymity of the participants and the data will be strictly maintained throughout the research. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Special school teachers who are between the age of 21- 50 years and working as full-time employee.
-Special school teachers who are have minimum qualification of diploma in special education.
-Special school teachers who have at least one year of teaching experience.
-Special school teachers who are willing to participate and are using smart phone.
-Special school teachers who can read, write or understand English or Kannada |
|
| ExclusionCriteria |
| Details |
-Special school teachers who have undergone any training or course related to mindfulness, personality training or any interventions focused on psychological well-being and practicing daily for past 6 months.
-Special school teachers who have psychiatric problems and serious physical health problems(neoplasm, neurological problems) that may significantly affect their stress level |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occupational stress, coping strategies, resilience and quality of life |
Baseline assessment, first, third and sixth month after the implementation of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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 |
|
Date of First Enrollment (India)
|
24/10/2025 |
| 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="2"
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
|
Introduction Teaching is an occupation and a profession in which stress is associated with it. Teachers are generally involved in activities which cause physical, mental and job stress. A special school teacher is a person who works with students who have special needs. Their primary goal is to provide specialized education and support to those students to overcome their academic, physical, social and mental stress. Purpose of the study The purpose is to develop an intervention program and to evaluate its effects in terms of occupational stress, coping strategies, resilience level and quality of life among special school teachers. Hypotheses All the hypotheses will be tested at 0.05 level of significance 1. There will be significant difference in the post test scores of : 1.1 occupational stress between intervention and control arm special school teachers 1.2 coping strategies between intervention and control arm special school teachers 1.3 quality of life between intervention and control arm special school teachers 1.4 resilience level between intervention and control arm special school teachers 1. |