| CTRI Number |
CTRI/2021/06/034024 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to see the number of anxiety cases between elective and emergency caesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of preoperative anxiety in elective and emergency caesarean section under sub-arachnoid block: An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Kumar Choudhary |
| Designation |
Post Graduate Student |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of anaesthesiology and critical care, Pt JNM medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7999189829 |
| Fax |
|
| Email |
0rajendra53990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Naik Bhuaarya |
| Designation |
Associate professor |
| Affiliation |
Pt JNM medical College, Raipur |
| Address |
Department of anaesthesiology and critical care, Pt. JNM Medical College, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9977420989 |
| Fax |
|
| Email |
rashminaik.2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Naik Bhuaarya |
| Designation |
Associate professor |
| Affiliation |
Pt JNM medical College, Raipur |
| Address |
Department of anaesthesiology and critical care, Pt. JNM Medical College, Raipur
Koriya
CHHATTISGARH
492001
India |
| Phone |
9977420989 |
| Fax |
|
| Email |
rashminaik.2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Naik Bhuaarya |
| Address |
Department of anaesthesiology and critical care, Pt JNM Medical College, Raipur |
| 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 Rajendra Kumar Choudhary |
Dr Bhim Rao Ambedkar Memorial Hospital, Raipur |
Dept of Anaesthesiology and Critical care
Pt JNM Medical College Raipur
Raipur
CHHATTISGARH |
7999189829
0rajendra53990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt JNM Medical College, Raipur(C.G.) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: No, (2) ICD-10 Condition: O299||Unspecified complication of anesthesia during pregnancy, (3) ICD-10 Condition: O299||Unspecified complication of anesthesia during pregnancy, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA II 2.Age 18-45 years 3.Full term pregnancy undergoing elective or emergency caesarean section under subarachnoid block |
|
| ExclusionCriteria |
| Details |
1.Patient refusal 2.Language barrier 3.Illiterate patient 4.Known psychiatric illness 5.Patients on anti anxiety or antidepressant medications 6Bad obstetric history, complicated pregnancy or having congenital fetal anomaly |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of pre-operative anxiety in elective and emergency caesarian section under subarachnoid block |
For elective group one day before surgery, For emergency group on same day of caesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the grade of anxiety in elective and emergency caesarian section under subarachnoid block
2. To compare anaesthesia related factors associated with preoperative anxiety in elective and emergency caesarian section under subarachnoid block
3. To compare pregnancy related factors associated with preoperative anxiety in elective and emergency caesarean section under sub-arachnoid block |
For elective group one day before surgery, For emergency group on same day of caesarean section |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="304"
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)
|
14/06/2021 |
| 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="0"
Months="9"
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
|
This is an observational randomised cross sectional study to compare the difference in incidence of preoperative anxiety in elective and emergency caesarean section under sub-arachnoid block between age group 18-45 years with ASA physical state II full term pregnancy. It will be conducted at single center in India. The primary outcome measures will be To compare the incidence of pre-operative anxiety using STAI Questionnaire and secondary outcomes will be to compare the grade of anxiety, To compare anaesthesia related factors associated with preoperative anxiety To compare pregnancy related factors associated with preoperative anxiety using PRAQ-R2 Questionnaire. |