| CTRI Number |
CTRI/2021/08/035534 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How the anxiety of the parturients after seeing the procedure of spinal anesthesia video before the operation |
|
Scientific Title of Study
|
Effect of pre-operative video based education about spinal anesthesia on anxiety in parturients undergoing caesarean section under spinal anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SIVA KUMAR P |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE
VMMC&SAFDARJUNG HOSPITAL
NEW DELHI
South
DELHI
110029
India |
| Phone |
805630694 |
| Fax |
|
| Email |
emailidforsiva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARUL MULLICK |
| Designation |
PROFESSOR |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE
VMMC&SAFDARJUNG HOSPITAL
NEW DELHI
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
parash93@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SIVA KUMAR P |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE
VMMC&SAFDARJUNG HOSPITAL
NEW DELHI
South
DELHI
110029
India |
| Phone |
805630694 |
| Fax |
|
| Email |
emailidforsiva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College & Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College Safdarjung Hospital |
| Address |
Ansari Nagar near AIIMS Hospital New Delhi |
| 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 |
| SIVA KUMAR P |
Vardhman Mahavir Medical College & Safdarjung Hospital |
Ansari Nagar near AIIMS Hospital New Delhi
South
DELHI |
8056630694
emailidforsiva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O298||Other complications of anesthesiaduring pregnancy, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Video based education about spinal anaesthesia |
Video based education about spinal anaesthesia on in parurients undergoing caesarean section |
| Intervention |
Video based education about spinal anaesthesia |
Video based education about spinal anaesthesiaon anxiety in partirients undergoing caesarean section |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients in the age group of 20 to 40 years, American Society of Anesthesiologists grade I and II undergoing elective caesrean section under spinal anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
1.Parturients with previous history of surgery under spinal or general anesthesia.
2.History of psychiatric disease.
3.Treatment with antidepressant drugs.
3.Patients with cognitive, visual, or speech disorders.
4.Enrolled patients who subsequently required emergency surgery or required general anaesthesia will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of video-based education about spinal anaesthesia on preoperative anxiety assessed by State-Trait Anxiety Inventory (STAI) score on day of surgery in preoperative holding area, in parturients undergoing elective caesarean section under spinal anaesthesia. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence and severity of postoperative nausea and vomiting at 2h and 24 h and antiemetic requirement in 24 h
2. Maternal satisfaction at 24 h postoperative time
|
2 hr and 24 hr |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
09/08/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM To determine the
effect of preoperative video-based education about spinal anaesthesia on
preoperative anxiety in parturients undergoing elective caesarean section under
spinal anaesthesia HYPOTHESIS Preoperative video-based education about
spinal anaesthesia reduces anxiety in parturients undergoing caesarean section
under spinal anaesthesia |