| CTRI Number |
CTRI/2026/01/102095 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study about educating patients about pre surgery anxiety |
|
Scientific Title of Study
|
The impact of patient education on minimizing preoperative anxiety related to anesthesia and surgery |
| 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 Nirmit Kamleshbhai Shah |
| Designation |
3rd year PG Resident |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9811585518 |
| Fax |
|
| Email |
nirmitshah2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor, Md anesthesia |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Professor, Md anesthesia |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre,
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital,Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India |
|
|
Primary Sponsor
|
| Name |
SmtBhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SBKS MIRC Sumandeep vidhyapeeth |
SBKS MIRC Sumandeep vidhyapeeth , pipariya, vadodara, Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nirmit Shah |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj hospital , Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India
Vadodara
GUJARAT |
9811585518
nirmitshah2109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
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 |
| Intervention |
In all pre operative patients on the day of surgery |
Patients will be re-assessed for preoperative anxiety using Amsterdam preoperative anxiety and information scale |
| Comparator Agent |
In all preoperative patients night before surgery |
Patients will be assessed for anxiety by using Amsterdam preoperative anxiety and information scale, then patient will be explained about the mode of anaesthesia, surgical procedure and postoperative recovery using verbal explanation and information |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving consent
Patient with asa 1,2 grade
Patient posted for elective surgeries under general or regional anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Patient with asa 3,4,5 grade
Patient with any psychiatric illness
Patient being taken for emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the effect of preoperative education on anxiety level among patients undergoing surgery or invasive procedure |
12hrs before surgery, 2hrs before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the effect of educating patients about anaesthetic procedure, surgery |
12hours before surgery, 2hrs before surgery |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
06/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 is common among surgical patients due to fears of pain, disability, loss of control, and even death. Hospitalization further increases anxiety because of unfamiliar environments, communication issues, and separation from family. High levels of anxiety can negatively affect coping, delay healing, and increase morbidity and mortality. Many patients experience greater anxiety when they lack adequate information about their illness and treatment. Preoperative education, which includes health information, psychological support, and skill preparation, can reduce anxiety, improve recovery, and shorten hospital stay. This study aims to provide evidence on how patient education helps reduce preoperative stress related to anesthesia and surgery. |