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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  
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 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  
Status 
Not Applicable 
 
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.

 

 
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