| CTRI Number |
CTRI/2019/10/021619 [Registered on: 14/10/2019] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare anxiety level in patients who are undergoing pain management procedure in prone position for the first time and in patients who has experience of such kind of procedure before in past |
|
Scientific Title of Study
|
Comparative study of pre-procedural anxiety in patients undergoing intervention pain management in prone position under monitored anesthesia care: first timer vs experienced |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Srivastava |
| Designation |
professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Science |
| Address |
Department of Anesthesiology,
Sanjay Gandhi Postgraduate Institute of Medical Science,
Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904594 |
| Fax |
0522268017 |
| Email |
shashi@sgpgi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Srivastava |
| Designation |
professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Science |
| Address |
Department of Anesthesiology,
Sanjay Gandhi Postgraduate Institute of Medical Science,
Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904594 |
| Fax |
0522268017 |
| Email |
shashi@sgpgi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra vaniya |
| Designation |
MD student |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Science |
| Address |
Department of Anesthesiology,
Sanjay Gandhi Postgraduate Institute of Medical Science,
Lucknow, UP
Type 4/68,
Sanjay Gandhi Postgraduate Institute of Medical Science,
Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9044837586 |
| Fax |
0522268017 |
| Email |
drsanjaygupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Science,Lucknow, UP |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Science |
| Address |
Sanjay Gandhi Postgraduate Institute of Medical Science, Raibareily Road, Lucknow |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashi Srivastava |
Sanjay Gandhi Postgraduate Institute of Medical Science, Raibareily Road, Lucknow |
Pain Operation theatre, , Main OT complex, Ist floor
Departement of Anaesthesiology
Lucknow
UTTAR PRADESH |
8004904594
05222668017
shashi@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing intervention pain management in prone position under monitored anesthesia care, (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients undergoing Interventional Pain Management will be included in this study. |
|
| ExclusionCriteria |
| Details |
1 Patient’s refusal
2 Inability to read or speak / communicate
3 Overt behavioral impairment / psychiatric illness
4 Patients on anti-anxiety drug
5 The presence of systemic or local infection.
6 Allergy to contrast dye, local anesthetic drug
7 Coagulopathy or bleeding disorder
8 Extreme fear of needles
9 Patients with history of complication during last interventional pain management procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of anxiety level before the procedure in patients undergoing interventional pain management for the first time in comparasion to patients who had undergone interventional pain management in past and now have been admitted for same procedure. |
Before the procedure . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of expected pain before procedure and pain experienced during procedure in patients undergoing interventional pain management for the first time in comparasion to patients who had undergone interventional management in past and now have been admitted for the same procedure |
Before and after procedure |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2016 |
| Date of Study Completion (India) |
31/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
no publication done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a MD thesis. it is an observational comparative study of anxiety level in patients undergoing interventional pain management for the first time and in patient who had undergone interventional pain management in past and now have been admitted for same procedure. 400 patients in 18 month will be included in this study.VISUAL ANALOG SCALE (VAS) will be used for anxiety monitoring. Primary outcome is anxiety level before the procedure in patients undergoing interventional pain management for the first time in patients who had undergone intervention pain management in past and now have been admitted for same procedure. |