| CTRI Number |
CTRI/2024/07/070783 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Regional Anaesthesia Video on Patient Anxiety |
|
Scientific Title of Study
|
Effect of Pre-anaesthetic Procedural Video Related to Regional Anaesthesia on
Patient Anxiety : A Prospective Observational 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 |
Imsha Imthiyaz Ali |
| Designation |
Postgraduate Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology
K S Hegde Medical Academy
Nityanandanagar, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363891868 |
| Fax |
|
| Email |
imshaimthiyazali4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joylin Dsouza |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology
Justice K S Hegde Charitable Hospital
Nityanandanagar, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901900185 |
| Fax |
|
| Email |
drjoysteff@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Imsha Imthiyaz Ali |
| Designation |
Postgraduate Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology
K S Hegde Medical Academy
Nityanandanagar, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363891868 |
| Fax |
|
| Email |
imshaimthiyazali4@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy
Nityanandanagar Deralakatte
Mangaluru Dakshina Kannada India
575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte, Nityanandanagar,
Mangaluru 575018 |
| Type of Sponsor |
Private 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 Joylin Dsouza |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology,
Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA |
9901900185
drjoysteff@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical Academy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All The Patients with ASA Grade I,II,III and IV Undergoing Elective Procedures Under Regional Anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Emergency surgery
Obstectrics Patients
Patients Who Cannot Understand and Comprehend The APAIS Questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Measure Pre-anaesthetic Anxiety Scores in Patients Undergoing Surgery Under Regional Anaesthesia Using APAIS Scale After Providing Video Information About Anaesthetic Technique |
During Pre-anaesthetic Evaluation and THE DAY OF SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Measure Patient Satisfaction About Anaesthetic Experience |
Post Operative Period |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/07/2024 |
| 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="0"
Months="6"
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
|
To Analyze The Effect of an Informative Video About Regional Anaesthetic Technique on Peri-operative Anxiety in Patients Undergoing Surgical Procedure Under Regional Anaesthesia. Assessing patient satisfaction with overall experience of anaesthesia |