| CTRI Number |
CTRI/2025/11/097367 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Does being anxious before surgery makes pain feel worse after ward |
|
Scientific Title of Study
|
Association between preoperative anxiety and postoperative pain in patients undergoing elective 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 |
PRASHANT KUMAR SINGH |
| Designation |
M Sc Anaesthesia and Operation Theater Technology |
| Affiliation |
K S Hegde Medical Academy |
| Address |
5th floor Anaesthesia and Operation Theater Technology, K S HEGDE MEDICAL ACADEMY DERLAKATTA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7782051318 |
| Fax |
|
| Email |
prashantkumar.singh1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashritha Kumary Shetty |
| Designation |
Assistant Professor Department of Anaesthesiology and Critical Care |
| Affiliation |
Justice K S Hegde Charatiable Hospital |
| Address |
Department of Anaesthesiology and Critical Care Justice K S Hegde Charatiable Hospital
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9591310788 |
| Fax |
|
| Email |
ashrithashetty19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashritha Kumary Shetty |
| Designation |
Assistant Professor Department of Anaesthesiology and Critical Care |
| Affiliation |
Justice K S Hegde Charatiable Hospital |
| Address |
Department of Anaesthesiology and Critical Care Justice K S Hegde Charatiable Hospital
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9591310788 |
| Fax |
|
| Email |
ashrithashetty19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PRASHANT KUMAR SINGH |
| Address |
House no 46. Bishanpur Beduliya, Jandaha, Vaishali, Bihar 844505 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PRASHANT KUMAR SINGH |
Room no. 921, 9th Floor Abhay Boys Hostel, K S Hegde Medical Academy |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prashant Kumar Singh |
Justice K S Hegde Charitable Hospital |
First floor pre and post operative wards
Dakshina Kannada
KARNATAKA |
7782051318
prashantkumar.singh1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde medical academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I152||Hypertension secondary to endocrine disorders, (2) ICD-10 Condition: E038||Other specified hypothyroidism, (3) ICD-10 Condition: E210||Primary hyperparathyroidism, (4) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years
Patients with ASA more or equal to 3
Patients undergoing elective surgery under General Anaesthesia
|
|
| ExclusionCriteria |
| Details |
Unable to give consent
Unable to communicate
Previously diagnosed depression and anxiety disorder on psychiatric treatment
Participants with cognitive impairment
Patients with pre-existing pain who are on analgesics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the association between preoperative anxiety and postoperative pain. |
2 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the total analgesic consumption in the first 24 hours of the postoperative period.
To evaluate the association between demographic data (age, gender, educational status, type of surgery, prior surgical exposure) on preoperative anxiety and postoperative pain.
|
5 times |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="190" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
28/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
One of the key effects of preoperative anxiety is increased postoperative pain. Despite the availability of numerous methods and interventions to reduce postoperative pain, patients may still experience it, with preoperative anxiety being a potential contributing factor. Therefore, we are studying the relationship between preoperative anxiety and postoperative pain. STAI is time-consuming, consisting of 40 questions. Therefore we will be using the APAIS scoring system to measure preoperative anxiety as it is quickly performed and easy to understand |