| CTRI Number |
CTRI/2024/01/061354 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Respiratory Sinus Arrhythmia (Breathing Exercise) treatment for anxiety |
|
Scientific Title of Study
|
Respiratory Sinus Arrhythmia, a Biofeedback technique as a Biobehavioral approach for anxiety symptoms. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha |
| Designation |
Student |
| Affiliation |
KMC Manipal |
| Address |
Department of Physiology Kasturba Medical College Tiger circle Road Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7899611287 |
| Fax |
|
| Email |
dideeksha7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi L C |
| Designation |
Assistant Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Physiology Kasturba Medical College Tiger circle Road Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9480335075 |
| Fax |
|
| Email |
pallavi.lc@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi L C |
| Designation |
Assistant Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Physiology Kasturba Medical College Tiger circle Road Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9480335075 |
| Fax |
|
| Email |
pallavi.lc@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Research grant Kasturba Medical College Manipal, Madhav Nagar,Manipal -576104 |
|
|
Primary Sponsor
|
| Name |
Deeksha |
| Address |
Department of Physiology KMC Manipal |
| 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 |
| Dr Pallavi L C |
KMC Manipal |
Autonomic Function Testing Lab in the Department of Physiology, KMC, Manipal
Udupi
KARNATAKA |
9480335075
pallavi.lc@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
We are recruiting Healthy volunteers with anxious symptoms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Pre and Post assessment |
Volunteers would be randomized into Intervention and Non-intervention group. Intervention group : It will receive Pre and Post assessment which is basically a Breathing Exercise.
Non-intervention group: will not receive any kind of intervention.
The total duration of the intervention will be around 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with anxious symptoms between 18 to 30 years of both gender who are able to read & write English and individuals without any psychiatric disorders can participate in this study. |
|
| ExclusionCriteria |
| Details |
Individual without anxious symptoms Individual with any form of abnormal cardiac rhythm, Cognitive impairment, diagnosed anxiety disorder or any other psychiatric disorders are excluded and
chronic illness on medication. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
For HRV,
1.Total Power
2.High Frequency
3.Low Frequency
4.HF in Normalized Units
5.LF in Normalized Units
6.HF/LF Ratio
7.Mean-RR
8.SDNN
9.RMSSD
10.NN50
11.pNN50
For Cognition,
1.Accuracy(%)
2.Errors
3.Duration
4.Response Time
|
At Baseline 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| 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="0"
Months="10"
Days="30" |
|
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
|
Anxiety is a feeling of instability such as fright that can be mild or acute. Anxiety being shown have a strong relationship to emotional & behavioural problems, thereby lack of selfcare having unhealthy lifestyle are risk factors for anxiety among younger generation. Untreated anxiety can have a notable impact on cognitive performance and academic achievement. When individuals experience chronic anxiety, then often remain in a high alertness, which can lead to increased levels of stress hormone called cortisol. High levels of cortisol can affect the cognitive function. Heart Rate Variability (HRV) is a time interval between heart beats which is a maker of one’s wellbeing. Individuals who having anxiety are characterized by chronically low HRV status. HRV self-measurement is simple to use and practice tool which is guided by timed breathing that allows for an essential identification of resonance frequency to maximize personal HRV training. By using HRV biofeedback training, the HRV will increases in people with anxious symptoms, and it will also reduce cortisol levels. By correcting the feedback loop, we try to reduce the anxious symptoms and thereby also see whether there is improvement in the cognition function. Volunteers would be screened using Zung Anxiety scale self-assessment tool. The volunteers with anxiety scale scoring above 45 will be taken into the study and would be randomized into Intervention and Non-intervention groups. Here the Non-intervention group acts as a control group with anxious symptoms. Both the groups to have baseline parameters for HRV and cognition test. It will take approximately 1 h |