| CTRI Number |
CTRI/2024/08/072214 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of showing informational video before surgery and assessing their
perioperative anxiety levels in patients undergoing
surgery under general anesthesia |
|
Scientific Title of Study
|
Effect of preoperative informational video on
perioperative anxiety in patients undergoing
surgery under general anesthesia-
A Randomized control 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 |
Dr Archana Natarajan |
| Designation |
Pg resident |
| Affiliation |
Ims and sum hospital |
| Address |
Department of Anesthesiology institute of medical sciences and sum hospital
bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8056225099 |
| Fax |
|
| Email |
archanazeal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sukdev Nayak |
| Designation |
Head of department |
| Affiliation |
Ims and sum hospital |
| Address |
Department of Emergency medicine, institute of medical sciences and sum hospital
bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9338904400 |
| Fax |
|
| Email |
sukhdev.nayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Natarajan |
| Designation |
Pg resident |
| Affiliation |
Ims and sum hospital |
| Address |
Department of anesthesiology
institute of medical sciences and sum hospital
bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8056225099 |
| Fax |
|
| Email |
archanazeal@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute of medical sciences and sum hospital, bhubaneswar, odisha, india 751003 |
|
|
Primary Sponsor
|
| Name |
institute of medical sciences and sum hospital |
| Address |
kalinga nagar, bhubaneswar, odisha, india 751003 |
| 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 Archana Natarajan |
institute of medical sciences and sum hospital |
department of anesthesiology, Bhubaneswar 751003
Khordha
ORISSA |
8056225099
archanazeal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, institute of medical sciences and sum hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Patients who watch preoperative informational video along with doubt clearing session with an anaesthesiologist, who isn’t part of the research.
Â
|
Before getting the pre anestheic checkup done, Patients will be made to watch pre operative informational video and assessing their anxiety levels by score just before surgery and also assessing their vitals pre intra and post operatively |
| Comparator Agent |
Group 2: Patients who receive routine preoperative care without the additional video. |
during pre anesthetic checkup patients wont be made to watch any informational video along with regular pre anesthetic assessment and anxiety assessment levels will be checked before surgery who are in this control group, pre intra and post vitals are also noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to American Society of Anesthesiologists Physical Status (ASA PS) I and II scheduled for elective surgery under general anaesthesia.
2.Adults aged 18 to 65 years.
3.Patients who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of severe psychiatric illness, uncooperative patients.
2.Patients with significantly impaired eyesight or hearing
3.Patients unable to provide informed consent, patient refusal
4.Patients with expected surgical duration of more than 4 hours.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To utilize Hamilton Anxiety Rating Scale (HAM-A) to evaluate anxiety levels among patients undergoing surgery.
|
scoring will be done before surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess changes in hemodynamic parameters including SBP, DBP, and HR.
|
pre video and post video pre surgery intra surgery and post surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
19/08/2024 |
| 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="1"
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
|
Effect of preoperative informational video on perioperative anxiety in patients undergoing surgery under general anesthesia- A Randomized control study •Anxiety assessment scores like
the Hamilton Anxiety Rating Scale (Ham-A) provide a standardized method for
evaluating anxiety levels, enabling early intervention and emotional support.
•This approach underscores the
importance of addressing both physical and psychological aspects to ensure
comprehensive patient well-being. |