| CTRI Number |
CTRI/2021/06/034116 [Registered on: 09/06/2021] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chronic pain management during COVID 19 Pandemic |
|
Scientific Title of Study
|
An analysis of pain management of patients with chronic pain amid COVID 19 pandemic: a cross-sectional observational trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Room number 521
D block, level 5
Anaesthesia and Intensive care
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Room number 521
D block, level 5
Anaesthesia and Intensive care
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Room number 521
D block, level 5
Anaesthesia and Intensive care
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital
Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and hospital |
| Address |
Sector 32, Chandigarh |
| 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 |
| Vanita Ahuja |
Government Medical College and Hospital |
Room number 521, Anaesthesia and Intensive Care
D Block, level 5
GMCH
Sector 32
Chandigarh
CHANDIGARH |
9646121649
vanitaanupam@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were earlier visiting but now not visiting GMCH during pandemic for chronic pain management
Non cancer chronic pain more than three months
|
|
| ExclusionCriteria |
| Details |
Not willing to participate in online survey |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate pain scores of patients with chronic pain amid COVID 19 pandemic |
At one point time only i.e. when the patients will be filling online questionnaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate analgesic intake and coping strategies amid COVID 19 pandemic
Demographics of patients with chronic pain participating in the survey
|
At one point time only i.e. when the patients will be filling online questionnaire |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
21/06/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic pain causes suffering and reduced quality of life. During COVID 19 there is a greater emphasis on social distancing and staying at home for people with non-emergent work. This isolation has led to psychological depression and anxiety symptoms in people. This situation is in contrast to the requirement of patients suffering from chronic pain who need to visit hospital for pain management and associated medical care. During COVID 19 pandemic patients with chronic pain are now exposed to unique challenges of attending telemedicine and teletherapy. In the absence of regular outpatient departments patients sometimes tend to self-medicate themselves. This has led to inadequate pain management as access to holistic care of bio-psychosocial management is now being done by audiovisual platforms. The present cross sectional observational study is planned to evaluate pain relief, drug therapies and other coping strategies adopted by patients during this period of COVID 19 pandemic. |