| CTRI Number |
CTRI/2022/07/044252 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
16/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of anxiety levels in patients undergoing interventional pain procedures |
|
Scientific Title of Study
|
Evaluation of anxiety levels in patients undergoing interventional pain procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PUNEET KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY |
| Address |
PAIN WARD , SHATABDI PHASE 1 HPSPITAL, KGMU
DEPARTMENT OF ANESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY , LUCKNOW, U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9598266693 |
| Fax |
|
| Email |
doctorpuneet007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Proff MANISH KUMAR SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY , LUCKNOW, U.P.
DEPARTMENT OF ANESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY , LUCKNOW, U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Proff MANISH KUMAR SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY , LUCKNOW, U.P.
DEPARTMENT OF ANESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY , LUCKNOW, U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
|
Source of Monetary or Material Support
|
| KING GEORGE MEDICAL UIVERSITY, LUCKNOW, UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANESTHESIOLOGY KING GEORGE MEDICAL UNIVERSITY LUCKNOW UP |
| Address |
DEPARTMENT OF ANESTHESIOLOGY KING GEORGE MEDICAL UNIVERSITY LUCKNOW UP |
| 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 |
| DR PUNEET KUMAR |
KING GEORGE MEDICAL UNIVERSITY |
PAIN WARD SHATABDI HOSPITAL PHASE 2
Lucknow
UTTAR PRADESH |
9598266693
doctorpuneet007@gmail.com |
|
|
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: R450||Nervousness, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 PATIENT AGE 18 YEARS AND ABOVE
2 ASA I II III |
|
| ExclusionCriteria |
| Details |
1 PSYCHIATRIC ILLNESS PATIENTS
2 PATIENT WITH SIGNIFICANT COGNITIVE IMPAIRMENT
3 PATIENT WITH COAGULATION ABNORMALITIES |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE ANXIETY AND ITS PREVALENCE IN PATIENTS UNDERGOING INTERVENTIONAL PAIN RELIEVING PROCEDURES |
BEFORE AND AFTER PROCEDURES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE PRE AND POST PROCEDURE ANXIETY LEVELS AND ESTABLISH ROLE OF INTERVENTION IN CAUSING ANXIETY |
BEFORE AND AFTER PROCEDURES |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
25/07/2022 |
| 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
|
AFTER THESIS COMPLETION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE STUDY WILL BE DONE BY STAI QUESTIONNAIRE GIVEN TO THE PATIENTS UNDERGOING INTERVENTIONAL PAIN RELIEVING PROCEDURES FOR SELF ADMINISTRATION AND COMPARISON BETWEEN PRE AND POST PROCEDURES ANXIETY LEVELS EVALUATED. |