| CTRI Number |
CTRI/2024/04/065530 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Single Arm Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pre-operative Anxiety and Pain |
|
Scientific Title of Study
|
Evaluation of Pre-operative Anxiety & Its Relation to Post-operative Pain in Patients Undergoing Elective Brain Tumor Surgery. 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 |
Mynu Arya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Uttaranchal
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9149161525 |
| Fax |
|
| Email |
mynu.arya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjay Agarwal |
| Designation |
Head and Professor of Department of Anaesthesiology |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Uttaranchal
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sanjay Agarwal |
| Designation |
Head and Professor of Department of Anaesthesiology |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology and Critical Care
AIIMS Rishikesh
Virbhadra Road Rishikesh
Dehradun
Uttaranchal
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
Mynu Arya |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Rishikesh Virbhadra Road, Rishikesh, Uttarakhand |
| 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 Mynu Arya |
Department of Anaesthesiology and Critical Care |
AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL |
9149161525
mynu.arya@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex
2. 18-70yrs of age
3. ASA Grade I-III
4. Undergoing elective craniotomy under general anaesthesia, who will be extubated on table. |
|
| ExclusionCriteria |
| Details |
1. Patients who refuse to participate in study
2. Unconscious patients
3. Patients with disabilities and cognitive impairment defined as a score less than or equal to 24 points in Mini Mental Status Examination
4. Patients not able to collaborate on Post-operative clinical assessment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive correlation between Pre-operative Anxiety and Post-operative Pain |
At 1 hour, 3 hour, 6 hour, 8 hour, 12 hour and 24 hour Post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare APAIS score & STAI score with NRS at 1 hour, 3 hour, 6 hour, 8 hour, 12 hour & 24 hour Post-operative period |
Consistent results in both APAIS score & STAI score at 1 hour , 3 hour, 6 hour, 8 hour, 12 hour & 24 hour Post-operative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/04/2024 |
| 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="2"
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
|
- The title of my study is "Evaluation of Pre-operative Anxiety and it’s relation to Post-operative Pain in patients undergoing elective brain tumor surgery. A Prospective Observational Study."
- Inclusion Criteria -
- Patients of either sex
- 18-70 yrs of age
- Patients with ASA 1 to ASA 3 status
- Undergoing elective craniotomy under general anaesthesia
- Patients who will be extubated on table
- Refusal to participate
- Unconscious Patient
- Patients with disabilities and cognitive impairment defined as a score less than or equal to 24 points in MMSE (Mini Mental Status Examination)
- Patient not able to collaborate on the Post-operative clinical assessment
- All the eligible patients will be informed about the anaesthesia method and assessed for Pre-operative Anxiety one day prior to the surgery with the help of STAI (State Trait Anxiety Inventory) and APAIS (Amsterdam Pre-operative Anxiety information scale) questionnaire .
- The patients will then be guided on how to perform Post-operative NRS to evaluate Post-operative Pain.
- Patients will undergo elective brain tumor excision or decompression under general anaesthesia.
- After the surgery, the patient will be evaluated according to NRS Score at 1 hour, 3 hour, 6 hour, 12 hour and 24 hour Post-operatively.
|