| CTRI Number |
CTRI/2024/12/078495 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [App] |
| Study Design |
Other |
|
Public Title of Study
|
Mobile app to reduce anger and stress |
|
Scientific Title of Study
|
Effectiveness of Anger and stress management techniques by a newly designed app in tertiary care centre, A quasi experimental study |
| 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 Dinesh Kumar V |
| Designation |
Post graduate in department of community medicine |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
Saveetha Medical College
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu - 602105 Saveetha Medical College
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu - 602105 Chennai TAMIL NADU 600037 India |
| Phone |
8072334422 |
| Fax |
|
| Email |
dineshhearthijacker@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Buvnesh Kumar M |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
260/6, Anbu colony, Annanagar, Chennai Saveetha Medical College
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu - 602105 Chennai TAMIL NADU 600040 India |
| Phone |
9176899784 |
| Fax |
|
| Email |
buvnesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dinesh Kumar V |
| Designation |
Post graduate |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
Saveetha Medical College
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu - 602105 Saveetha Medical College
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu - 602105 Chennai TAMIL NADU 600037 India |
| Phone |
8072334422 |
| Fax |
|
| Email |
dineshhearthijacker@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Institute of Medical and Technical sciences,
Saveetha Nagar, Thandalam,
Chennai, Tamil Nadu, 602105
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Dinesh Kumar V |
Saveetha institute of medical and technical sciences |
Department of community medicine/Integrated Clinic/1-4 Chennai TAMIL NADU |
8072334422
dineshhearthijacker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F488||Other specified nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Anger and stress management application |
App will be provided for those with elevated anger and stress levels, pre and post test will be conducted before and after providing app, after 15 days of intervention anger and stress levels will be measured by standardised quiestionarre |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Adults aged 18 and above.
2)Individuals experiencing stress and/or anger-related issues, including those with hypertension.
3)Users must possess basic literacy and technological proficiency to navigate the app independently or with minimal assistance.
4)Individuals with access to a compatible smartphone or tablet with reliable internet connectivity.
5)Willingness to engage with the app and participate in stress and anger management activities.
6)Appropriate language proficiency to understand app content |
|
| ExclusionCriteria |
| Details |
1)Minors under the age of 18.
2)Individuals with severe mental health disorders requiring immediate professional intervention (e.g., acute psychosis, severe suicidal ideation).
3)Users unable to provide informed consent or participate effectively due to cognitive impairment or severe physical limitations.
4)Lack of access to a compatible smartphone or tablet with internet connectivity.
5)Refusal or inability to consent to participate in the app-based intervention.
6)Individuals unable to comprehend app content due to language barriers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced anger and stress levels |
Baseline/15 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing anger & stress levels there by reducing risk of heart diseases, hypertension, & mental health conditions like sadness & anxiety. |
Baseline/15 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
03/01/2025 |
| 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="0" Months="0" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Anger and stress are common problems that the public faces and have a substantial impact on public health issues. Uncontrolled anger and chronic stress have been related to a number of harmful health effects, such as heart disease, hypertension, and mental health conditions like sadness and anxiety. If these disorders are not properly managed, they might worsen and lower one’s quality of life and health. Well-researched strategies for controlling these feelings include cognitive behavioural therapy (CBT), deep breathing exercises, and relaxation techniques like progressive muscle relaxation (PMR).With the development of mobile health (mHealth) technologies, there is a chance to increase the accessibility of these successful tactics through smartphone applications, offering ongoing access to therapeutic resources and real-time support. Although cognitive behavioural therapy (CBT) and relaxation techniques are readily available, there are notable disparities in the general public’s access to and efficacy of stress and anger management interventions. Many face obstacles like the stigma attached to receiving mental health care, limited access to comprehensive, user-friendly resources, and financial limitations. Many times, current mobile applications fall short of offering the useful, on-the-spot assistance required to control stress and rage in everyday circumstances. Furthermore, not much study has been done on how well these apps work for a wide range of users, especially when it comes to meeting the requirements of people from different backgrounds and with different degrees of stress and rage. It is still quite difficult to optimize these technologies in a way that will effectively serve the general population. By creating and assessing "IRA," a smartphone application meant to help people manage their stress and anger, this study aims to close the gap. IRA offers useful tools for immediate use by combining evidence-based CBT procedures with relaxation techniques including deep breathing and Progressive Muscle Relaxation (PMR). Our main goal is to evaluate IRA’s acceptance and usability among a wide range of users and investigate how it can support stress and anger management practices outside of conventional therapeutic settings. Our goal is to ascertain whether IRA may successfully lower treatment obstacles and enhance the mental and physical health of a large population, tackling a major public health issue with scalable solutions. |