| 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
|
|
|
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
|
|
|
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.
|