| CTRI Number |
CTRI/2024/03/063964 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Preoperative educational video and perioperative anxiety in patients undergoing lower segment caesarean section |
|
Scientific Title of Study
|
Effect of preoperative educational video on perioperative anxiety in patients undergoing lower segment caesarean section in Indian Setting: A Randomised Controlled 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 |
Ashutosh Kaushal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology,
AIIMS, Bhopal, Saket nagar
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9599156154 |
| Fax |
|
| Email |
drashutosh.kaushal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashutosh Kaushal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology,
AIIMS, Bhopal, Saket nagar
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9599156154 |
| Fax |
|
| Email |
drashutosh.kaushal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashutosh Kaushal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology,
AIIMS, Bhopal, Saket nagar
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9599156154 |
| Fax |
|
| Email |
drashutosh.kaushal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, BHOPAL, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
Saket Nagar, Bhopal, Madhya Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashutosh Kaushal |
All India Institute of Medical Sciences,Bhopal |
Department of Anaesthesiology, 3RD floor, Trauma complex,Saket Nagar
Bhopal
MADHYA PRADESH |
9599156154
drashutosh.kaushal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of MedicalSciences, Bhopal |
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 |
Control |
The control group will not show educational video but will receive all the standard perioperative care. |
| Intervention |
Low-cost informative anaesthetic educational video |
An educational video on the mobile phone of the investigator will be shown to this group of patients, meeting inclusion criteria in the dedicated room in the maternity ward |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all consenting primigravida patients scheduled for the LSCS under subarachnoid block. |
|
| ExclusionCriteria |
| Details |
visual or hearing impairment or psychiatric or anxiety disorder or history of previous surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare the effect of the preoperative educational video on perioperative anxiety by using the state anxiety inventory (Spielberger’s STAI) and Amsterdam preoperative anxiety scale. |
The night before surgery, 30 minutes before surgery, and 1 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare the effect of the preoperative educational video on the perioperative quantitative EEG |
The night before surgery, 30 minutes before surgery, and 1 hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prevalence of preoperative anxiety among obstetric patients who underwent lower segment caesarean section (LSCS) varies from 55% - 63%. This anxiety could lead to decreased postoperative satisfaction, delayed postoperative recovery, decreased quality of life, increased requirement of anaesthetics and analgesics, longer wound healing, longer hospital stay and hence the overall poor surgical outcome . Pain during the subarachnoid block, being awake during surgery, seeing or hearing during surgery, privacy breach, being paralysed after surgery and failure to wake up after surgery are some reasons why obstetric patients develop preoperative anxiety related to regional anaesthesia. The preoperative educational video is one of the recently explored non-pharmacological measures to decrease preoperative anxiety, with variable effects in previous studies. But these studies have been done in developed countries and may not apply to all socioeconomic and cultural settings. Also, there is a literature deficit regarding the effect of educational videos on the quantitative EEG (marker for stress/anxiety) to decrease perioperative anxiety. So, this study intends to evaluate the effect of cost-effective anaesthetic educational video on perioperative anxiety by incorporating the anxiety questionnaires and quantitative EEG in patients undergoing LSCS in the Indian setting. |