| CTRI Number |
CTRI/2024/12/078200 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of use of preoperative multimedia] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of use of multimedia prior to surgery to look for anxiety during the surgery in patients having abdominal and lower limb procedures in spinal anaesthesia |
|
Scientific Title of Study
|
Effect of use of preoperative multimedia on perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Khobar |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology, First floor, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9958500177 |
| Fax |
|
| Email |
divyakhobar098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeev Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology, First floor, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeev Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology, First floor, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, India - 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi- 221005 |
| 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 |
| Divya khobar |
Institute of Medical Sciences |
Department of Anaesthesiology, First floor, Banaras Hindu University
Varanasi
UTTAR PRADESH |
9958500177
divyakhobar098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I/II/III |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preoperative counselling |
Patients of control group will be verbally told about the procedure after Pre-anaesthetic checkup. |
| Intervention |
Preoperative multimedia |
Patients of test group will be shown a short video ( using smartphones) for 10 minutes depicting the general information on spinal anaesthesia and the procedure itself along with explanation of common myths of surgery and anaesthesia after Pre-anaesthetic checkup. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients undergoing abdominal and lower limb surgeries under
spinal anaesthesia, with intra operative supine position during
surgery.
2 Age- 18 years to 60 years.
3 Sex- both male and female.
4 Belonging to ASA Grade I/II/III |
|
| ExclusionCriteria |
| Details |
1 Patient refusal.
2 Patients who have impaired vision/hearing in either or both
eyes/ears respectively or are deaf in either or both ears.
3 History of mental illness (cognitive impairment).
4 Associated head ( traumatic brain injury), pelvic injuries.
5 Any contra-indications of spinal anaesthesia (bleeding diathesis,
infection of overlying skin etc.)
6 Patients undergoing surgery above umbilicus.
7 Any patient having undesired sensory and motor block. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of use of preoperative multimedia on perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia in the age group of 18-60 years. |
Baseline( a day prior to surgery) and 10 minutes after giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the use of rescue
analgesic drugs.
2 To study the side effects caused by
drugs.
3 To study the patient compliance.
4 To study the recovery period. |
Perioperative 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)
|
27/12/2024 |
| 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="3"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 the study is Effect of use of Preoperative multimedia in perioperative anxiety in patients undergoing abdominal and lower limb surgeries in spinal anaesthesia. 100 patients satisfying the above mentioned inclusion and exclusion criteria and undergoing abdominal and lower limb surgeries in spinal anaesthesia after obtaining the ethical committee clearance are included in the study. Sample size was calculated using previous similar study to detect a clinically significant difference in patients anxiety scores between groups, of >5 points to achieve power of 80% and error of 5%. 100 patients are randomly divided into 2 groups based on computer generated randomisation. After proper pre-anaesthetic workup of both the groups, first group will be shown the multimedia video and second group will be briefed verbally. Anxiety will be assessed in both the groups before the surgery and during the surgery using STAIT AND TRAIT ANXIETY SCORING SYSTEM (ranges from 20-80 points). No or low anxiety: 20-37 Moderate anxiety: 38-44 High anxiety: 45-80 |