| CTRI Number |
CTRI/2025/04/084728 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of deep breathing combined with biofeedback intervention in reducing anxiety symptoms among young adults |
|
Scientific Title of Study
|
Impact of Diaphragmatic Breathing and Biofeedback Intervention on Anxiety Among Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himon Baruah |
| Designation |
Clinical Psychology Trainee |
| Affiliation |
Rashtriya Raksha University |
| Address |
School of Behavioural Sciences and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam
Gandhinagar
GUJARAT
382305
India |
| Phone |
8011514435 |
| Fax |
|
| Email |
him18on@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh A Tripathi |
| Designation |
Director and Head of the Department of Clinical Psychology (Associate Professor) |
| Affiliation |
Rashtriya Raksha University |
| Address |
School of Behavioural Sciences and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam
Gandhinagar
GUJARAT
382305
India |
| Phone |
9724274415 |
| Fax |
|
| Email |
director.sbsfi@rru.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Himon Baruah |
| Designation |
Clinical Psychology Trainee |
| Affiliation |
Rashtriya Raksha University |
| Address |
School of Behavioural Sciences and Forensic Investigation, Rashtriya Raksha University, Lavad, Dahegam
Gandhinagar
GUJARAT
382305
India |
| Phone |
8011514435 |
| Fax |
|
| Email |
him18on@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rashtriya Raksha University |
|
|
Primary Sponsor
|
| Name |
Himon Baruah |
| Address |
School of Behavioural Sciences and Forensic Investigations, Rashtriya Raksha University, Lavad, Dahegam, Gujarat |
| 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 |
| Himon Baruah |
School of Behavioural Sciences and Forensic Investigations |
Rashtriya Raksha University,Lavad, Dahegam
Gandhinagar
GUJARAT |
8011514435
him18on@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rashtriya Raksha University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Experiencing Anxiety Symptoms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic Breathing and Biofeedback Training |
Participants who are interested will be recruited and they will complete a brief screening questionnaire to make sure they meet all the inclusion criteria. Upon arrival for the study, participants will be given an overview of the study and will provide informed consent. Participants will then complete the Beck Anxiety Inventory (BAI) to assess baseline anxiety levels and those who score 5 and above in BAI will only be included for the study. Baseline physiological measurements (GSR Ratings) will be collected using the biofeedback device to capture initial stress responses. All data collection will take place in a quiet, controlled environment to minimize external stressors. Participants will be asked to relax and then will be given instructions regarding deep breathing techniques and biofeedback and all their queries will be resolved. Participants will then undergo a 30 minute intervention session of Diaphragmatic Breathing and biofeedback simultaneously. Participants will undergo 8 such session over a period of one month ( 2 days per week). After the intervention, participants will again complete the BAI to assess changes in anxiety levels. Post-intervention physiological data (GSR Ratings), will be collected using the same biofeedback device. The data from the post-intervention assessment will be compared with baseline measurements to evaluate changes in both anxiety and physiological responses. After the post-intervention assessment, participants would be debriefed about the purpose of the study and the potential outcomes. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants willing to provide informed consent
2. Participants with BAI Scores 5 and above
|
|
| ExclusionCriteria |
| Details |
1. Participants younger than 18 years or older than 35 years
2. History of developmental, neurological or any other psychiatric illness
3. Ongoing medical conditions
4. History of substance abuse or ongoing substance use
5. Individuals taking any medication
6. Individual receiving any other therapeutic intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety levels in Beck Anxiety Inventory (BAI) |
Pre Intervention, Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Galvanic Skin Response (GSR) Ratings in Biofeedback |
Baseline and Actuals, Pre Intervention and Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study aims to examine the effectiveness of diaphragmatic breathing techniques combined with biofeedback in reducing anxiety levels among young adults. Anxiety is a growing concern in today’s fast-paced society, and non-pharmacological interventions like deep breathing and biofeedback offer promising, cost-effective solutions. The study follows a pre- and post-single-group experimental design, recruiting participants aged between 18 and 35 from Gujarat, India, through purposive sampling. Participants meeting the inclusion criteria (BAI score equal to or above 5) will undergo eight 30-minute intervention sessions over a period of one month, where they will practice diaphragmatic breathing while receiving real-time physiological feedback through a GSR biofeedback device. Pre- and post-intervention anxiety levels will be measured using the Beck Anxiety Inventory (BAI), along with physiological responses captured through biofeedback. The data will be analyzed using SPSS, employing appropriate statistical measures to compare pre- and post-intervention anxiety and physiological responses, along with exploring their relationship. The findings will contribute to understanding how individuals can train their physiological responses to manage anxiety effectively and may also provide insights into the potential implications of these techniques in forensic psychology, such as manipulating polygraph tests. |