| CTRI Number |
CTRI/2024/09/074411 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Heart Rate Variability Biofeedback] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Heart Rate Variability Biofeedback Training on Somatic Symptom Disorder Patients |
|
Scientific Title of Study
|
Effect of Heart Rate Variability Biofeedback on Somatic Symptom Disorder |
| 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 Renu Bhatia |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No.6018, 6th floor, Department of Physiology, Convergence block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8860169671 |
| Fax |
|
| Email |
renuaiims28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minal Kharat |
| Designation |
Juinor Resident(Acad.) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No.6007, Pain Research and TMS Laboratory, 6th Floor,Department of Physiology, Convergence Block, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8103713606 |
| Fax |
|
| Email |
minalkharat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minal Kharat |
| Designation |
Junior Resident (Acad.) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No.6007, Pain Research and TMS Laboratory, 6th Floor,Department of Physiology, Convergence Block, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8103713606 |
| Fax |
|
| Email |
minalkharat@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Minal Kharat |
All India Institute of Medical Sciences, New Delhi |
Room No.6007, Pain Research and TMS Laboratory, 6th Floor,Department of Physiology, Convergence Block, AIIMS New Delhi
New Delhi
DELHI |
8103713606
minalkharat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,AIIMS,NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F454||Pain disorders related to psychological factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group Receiving Standard therapy only |
Patients in this group will only receive standard therapy. No HRV biofeedback intervention will be given.Total Duration:4 weeks |
| Intervention |
Heart Rate Variability Biofeedback with standard therapy |
HRV Biofeedback Group
Total Duration of Intervention:4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.A minimum score of 5 in the Patient Health Questionnaire 15 (PHQ-15)
2.Presence of at least two somatic complaints with predominant pain.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of 4 weeks of Heart Rate Variability biofeedback training in patients with Somatic Symptom Disorder on:
a. Somatic symptom disorder severity (Patient Health Questionnaire-15,Somatic Symptom Disorder-8)
b. Pain status (Visual Analog Scale, Quantitative Sensory Testing)
c. Heart Rate Variability |
Baseline and at 4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
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
|
Somatic symptom
disorder presents a problem for both the physician and patient because it puts
patients at risk of unnecessary testing and treatment. The main feature of
these disorders is a concern with physical symptoms that are attributed to a
nonpsychiatric disease. This concern can manifest as one or more somatic
symptoms that result in excessive thoughts, feelings, or behaviors related to
those symptoms and that are distressing or result in significant disruption of
daily life. HRV biofeedback (HRVB) is a non-invasive therapeutic modality that
has been shown to be effective as an adjunct therapy in various chronic pain
disorders with stress as a pathophysiological feature. Very few studies
have investigated the effect of heart rate variability HRV biofeedback (HRVB)
training as an adjunct therapy in Somatic Symptom Disorder. Very little information
is available on the effect of HRVB on the pain and functional status in Somatic
Symptom Disorder. On the other hand, there is a lack of information regarding
the objective evaluation of HRVB on the pain status in Somatic Symptom Disorder.
Therefore, the
present study is planned to investigate the effect of heart rate variability biofeedback (HRVB) on pain
status,functional status and baroreceptor sensitivity in Somatic Symptom
Disorder patients. |