| CTRI Number |
CTRI/2024/11/076534 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Socio-demographic profile and associated psychosocial stressors in patient with conversion disorder |
|
Scientific Title of Study
|
Socio-demographic profile and associated psychosocial stressors in patient with conversion disorder: An exploratory cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Dalal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7065572123 |
| Fax |
|
| Email |
shwetadalal999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alexander Martin Alphonse |
| Designation |
HOD and Professor Psychiatry |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7208113849 |
| Fax |
|
| Email |
talentsondisplay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alexander Martin Alphonse |
| Designation |
HOD and Professor Psychiatry |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7208113849 |
| Fax |
|
| Email |
talentsondisplay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh, India 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Dalal |
| Address |
Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P. |
| 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 Shweta Dalal |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P. |
OPD no 235, Department Of Psychiatry
Shahjahanpur
UTTAR PRADESH |
7065572123
shwetadalal999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Varun Arjun Medical College and Rohilkhand Hospital, NH-24, Banthra, Shahjahanpur, Uttar Pradesh- 242307 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F447||Conversion disorder with mixed symptom presentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects of either gender, of age 18 years and above who will be diagnosed with conversion disorder.
2) Patients who are willing to take part in the study and give informed consent. |
|
| ExclusionCriteria |
| Details |
1) Subjects with past or current history of any organic or developmental psychiatric disorders, epilepsy or any neurological condition or major systemic illnesses.
2) Subjects who do not give written consent will not be the part of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study under consideration is to study socio-demographic profile and associated psychosocial stressors in patients of conversion disorder who present to the psychiatry department. This is an observational study and no intervention is carried out on study subjects. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
11/11/2024 |
| 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="0"
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
|
•Conversion disorder, historically intriguing and clinically challenging, presents a conundrum for neurologists and psychiatrists alike, potentially tracing its roots back to antiquity. Coined by Sigmund Freud, the term denotes an intricate interplay of unconscious conflicts, as outlined in the DSM-V, where somatic symptoms substitute suppressed ideas and manifests as symptoms mimicking neurological conditions but lacks neurological explanation upon examination. Stress emerges as a pivotal factor in its onset, typically occurring in early adulthood post-stressful events, ranking as the second most common reason for neurology outpatient consultations. Characterized by a disruption in memory integration, identity awareness, and bodily control, conversion disorder exhibits varied clinical profiles influenced by cultural factors. Primary and secondary gains, integral to its manifestation, offer insights into its etiology and presentation, often tied to socio-demographic factors and psychosocial stressors. This study seeks to unravel the socio-demographic factors and associated stressors in conversion disorder patients, particularly within the Indian cultural context, aiding psychiatrists in tailored interventions. |