| CTRI Number |
CTRI/2023/10/058745 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of two different methods in decreasing preoperative anxiety of patients undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
Effect of preoperative counseling using structured anesthesia information sheet versus conventional verbal counseling on preoperative anxiety of patients undergoing lower abdominal surgery-A Prospective randomised interventional study at sms medical college jaipur |
| 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 Anupama gupta |
| Designation |
senior professor |
| Affiliation |
sms medical college jaipur |
| Address |
Department of anesthesiology sms medical college jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama gupta |
| Designation |
senior professor |
| Affiliation |
sms medical college jaipur |
| Address |
department of anaesthesiology sms medical college jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annu kawre |
| Designation |
junior resident |
| Affiliation |
sms medical college jaipur |
| Address |
Department of anaesthesiology sms medical college jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
08770385616 |
| Fax |
|
| Email |
DRANNUKAWRE@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology sms medical college jaipur |
|
|
Primary Sponsor
|
| Name |
SMS medical college jaipur |
| Address |
department of anaesthesiology sms medical college jaipur |
| 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 |
| Dr anupama gupta |
sms medical college and hospital |
urology operation theatre super speciality block sms medical college and hospital
Jaipur
RAJASTHAN |
9414240245
anupamag213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics comittee sms medical college jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
effect of pre operative counseling using conventional verbal counseling on preoperative anxiety of patients undergoing lower abdominal surgery |
basic information given to patients about anaesthesia.Then difference in mean change in visual analogue scale for anxiety score from pre operative period before and after 2 hour of intervention is compared |
| Intervention |
effect of preoperative counseling using structured anaesthesia sheet on preoperative anxiety of patients undergoing lower abdominal surgery |
A detailed written information of different type of anaesthesia which is used for surgery is explained and shown to patient using structured anaesthesia information sheet.Difference in mean change in visual analogue scale for anxiety score from preoperative period before and after 2 hour of intervention is compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patient giving written and informed consent
patient undergoing lower abdominal surgery
age group of 18-45 year
ASA grade 1 and grade 2 |
|
| ExclusionCriteria |
| Details |
patient taking beta blocker medication
patient with any known psychiatric and memory disorder
patient with history of drug abuse or addiction
patient with history of smoking and alcohol
patient with history of hypertension |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference of Visual analogue scale for anxiety |
one day before surgery, 2hour before counseling, 2 hour after counseling |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean systolic blood pressure , mean diastolic blood pressure ,mean arterial pressure, mean heart rate
|
2hour before counseling, 2 hour after counseling |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
24/10/2023 |
| 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="0" |
|
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
|
Preoperative anxiety in surgical patients imposes stress and dissatisfaction.It results in altered neuroendocrine response and various perioperative complications. Preoperative anxiety can affect psychological and physiological parameters by activation of the hypothalamic–pituitary–adrenal axis. It can lead to deleterious effects on the haemodynamic parameters during the perioperative period; affect the overall anaesthesia management and surgical outcome by delayed awakening, post-operative pain, nausea– vomiting, delayed wound healing, and post-operative cardiac events during the intraoperative period. Pharmacological measures used to reduce preoperative anxiety have their associated adverse effects. Preoperative anaesthesia education is one of the nonpharmacological tools to reduce anxiety.Hence this study is designed to evaluate the effect of pre operative counseling of patients using anaesthesia information sheet on anaesthesia associated pre operative anxiety. |