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CTRI Number  CTRI/2024/11/077299 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare deep breathing and mindful breathing in patients with anxiety disorder for improving their anxiety.  
Scientific Title of Study   Effectiveness and acceptability of Mindful breathing and Deep breathing in patients with Anxiety Disorders: A randomised 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  DR. URVASHI KHICHAR 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS JODHPUR 
Address  AIIMS JODHPUR BASNI SECOND PHASE PSYCHIATRY DEPARTMENT FIRST FLOOR 1-C BLOCK

Jodhpur
RAJASTHAN
342005
India 
Phone  9079821608  
Fax    
Email  urvashiurvi789@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. MUKESH KUMAR SWAMI 
Designation  ADDITIONAL PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  ROOM NO 3142, MEDICAL COLLEGE BLOCK, DEPARTMENT OF PSYCHIATRY, AIIMS, JODHPUR

Jodhpur
RAJASTHAN
342005
India 
Phone  9079821608  
Fax    
Email  mukesh.swami@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR. URVASHI KHICHAR 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS JODHPUR 
Address  AIIMS JODHPUR BASNI SECOND PHASE PSYCHIATRY DEPARTMENT FIRST FLOOR 1-C BLOCK

Jodhpur
RAJASTHAN
342005
India 
Phone  9079821608  
Fax    
Email  urvashiurvi789@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCE JODHPUR, SECOND PHASE BASNI JODHPUR, RAJASTHAN, INDIA 342005 
 
Primary Sponsor  
Name  AIIMS JODHPUR RAJASTHAN 
Address  AIIMS JODHPUR BASNI SECOND PHASE JODHPUR, RAJASTHAN, INDIA, 342005 
Type of Sponsor  Government medical college 
 
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 URVASHI KHICHAR  AIIMS JODHPUR   AIIMS JODHPUR BASNI SECOND PHASE JODHPUR RAJASHAN, INDIA, 342005
Jodhpur
RAJASTHAN 
9079821608

urvashiurvi789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Deep Breathing  Inhale slowly and deeply through your nose into the "bottom" of your lungs--in other words, send the air as low down as you can. If you are breathing from your abdomen, your hand should actually rise. Your chest should move only slightly, while your stomach expands. When you have taken in a full breath, pause for a moment and then exhale slowly through your nose or mouth, depending on your preference. As you exhale feel your abdomen contract. As you exhale, allow your whole body to just let go (you might visualize your arms and legs going loose and limp like a rag doll). Do five slow, full abdominal breaths. Try to keep your breathing smooth and regular, without gulping in a big breath or letting your breath out all at once. Remember to pause briefly at the end of each inhalation. Each session will take 10 minutes including explanation and demonstration.  
Intervention  Mindful breathing  One of the first things we do in mindfulness based stress reduction is to become aware of our breath which we often forget. You dont have to control your breath, just notice it. Observe, watch and feel the breath with a sense of interest in a relaxed manner. With practice you become more aware of your breathing, and in turn are able to use it to direct your awareness to different aspects of your life. For example to relax tense muscles, or focus on a situation that requires attention and/or help with pain, anger, relationships or the stress of daily life. Each session will take 10 minutes including explanation and demonstration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  New Patients diagnosed with Anxiety or fear related disorders as per the ICD-11 criteria.
Patient having score on GAD-7 more than or equal to 10.
Able to understand Hindi/ English.
 
 
ExclusionCriteria 
Details  1.Patient with any other comorbid psychiatric disorder (except Tobacco use).
Patient diagnosed with any other medical disorder contributing to anxiety symptoms or disability.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the mindful breathing and deep breathing in improving state of relaxation in patients with anxiety disorder.   Evaluation at baseline
Evaluation at 2 weeks follow up  
 
Secondary Outcome  
Outcome  TimePoints 
To compare acceptability of mindful breathing and deep breathing.
To compare effect of mindful breathing and deep breathing on anxiety symptoms after first 2 weeks of treatment.
 
After 2 weeks 
 
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)   09/12/2024 
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="1"
Months="6"
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  
TITLE OF STUDY: Effectiveness and acceptability of Mindful breathing and Deep breathing in patients with Anxiety Disorders, A randomised trial

The purpose of this study is to examine the effectiveness and acceptability of two regularly used relaxation methods (deep breathing and mindful breathing) in individuals with anxiety disorders. This study comprises all patients over the age of 18 who visit the Department of Psychiatry’s Out-Patient setting and are diagnosed with anxiety disorders (moderate to severe anxiety as measured by the GAD-7 score) and can communicate in English or Hindi. Patients with a diagnosis of bipolar or related disorder, psychotic illness, other comorbid psychiatric illness, substance use disorder (excluding disorders caused by nicotine use), intellectual development disorder, other neurocognitive disorders, or any organic disorder presenting with a complaint of anxiety will be excluded from the study. In this study, we will compare two alternative interventions (deep breathing and mindful breathing) in patients with anxiety disorders, with the goal of determining if either relaxation strategy is equally successful in eliminating anxiety symptoms after a single session.

Research on the effectiveness and acceptability of relaxation methods in India is limited, with most studies involving non-clinical participants not diagnosed with psychiatric disorders. There is a significant gap in understanding the impact of these methods on individuals with diagnosed anxiety disorders. Additionally, previous studies did not specify whether relaxation techniques were administered in person or by healthcare professionals. Comparative evidence on the effectiveness of methods like deep breathing and mindful breathing in reducing anxiety is scarce, and data on participant adherence and acceptability is lacking. Gathering such data is crucial for improving future strategies, enhancing patient engagement, satisfaction, and adherence to treatment, and ensuring diverse implementation of effective anxiety management tools.

Future Implications: The study would generate data regarding comparison of deep breathing and mindful breathing, in terms of effectiveness and patients preference. The study will add to the evidence-based guidance for clinicians, supporting informed decision-making based on individual preferences. The findings could promote the use of both breathing exercises as long-term and preventive strategies for anxiety, potentially reducing the frequency and severity of anxiety disorders. With both techniques being effective, they can be integrated into comprehensive care plans that include other therapeutic modalities, improving overall treatment efficacy. The results will pave the way for future research comparing these techniques with other relaxation and mindfulness interventions, deepening our understanding of effective anxiety management practices.

 
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