| CTRI Number |
CTRI/2025/03/081518 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Anxiety and Depression in patients undergoing surgery a day prior and 48 hours after surgery |
|
Scientific Title of Study
|
PADon Study: Prevalence of Anxiety and Depression In Oncology Patients During Perioperative Period And Its Effect On Perioperative Pain–Prospective,observational single center study.
|
| Trial Acronym |
PADOn |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Bakshi |
| Designation |
PROFESSOR |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care and Pain,
Main Building, 2nd floor, OT complex,
Tata Memorial Hospital,
Parel,Mumbai
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
02224177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Bakshi |
| Designation |
PROFESSOR |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care and Pain,
Main Building, 2nd floor, OT complex,
Tata Memorial Hospital,
Parel,Mumbai
Mumbai
MAHARASHTRA
4000012
India |
| Phone |
02224177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanshi |
| Designation |
PG student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care and Pain,
Main Building, 2nd floor, OT complex,
Tata Memorial Hospital,
Parel,Mumbai
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177058 |
| Fax |
|
| Email |
hemanshi.goyal15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Critical Care and Pain, Tata Memorial Hospital,
Parel,Mumbai. INDIA
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia , Critical Care and Pain |
| Address |
Department of Anesthesia, Critical Care and Pain,
Main Building, 2nd floor, OT complex,
Tata Memorial Hospital,
Parel,Mumbai. INDIA
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sumitra G Bakshi |
Tata Memorial Hospital |
Department of Anesthesia, Critical Care and Pain,
Main Building, 2nd floor, OT complex,
Tata Memorial Hospital,
Parel,Mumbai. INDIA
Mumbai
MAHARASHTRA |
02224177058
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata memorial hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NIL |
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) Grade I -III
Patients undergoing oncological surgeries for:-
Gynecological Procedures
Orthopedic Procedures
Gastrointestinal Procedures
Urological Procedures
Thoracic Procedures
Head and Neck Procedures
Requiring postoperative admission in the hospital ward for a minimum 48 hours
|
|
| ExclusionCriteria |
| Details |
1 Patients unwilling to participate in the study.
2 Difficulty in communication because of language limitation or planned tracheostomy in the postoperative period.
3 Patients already receiving psychoactive medications.
4 Surgeries with expected cognitive impairment in the post-operative(Any pre-existing cognitive defects or Neurosurgeries).
5 Patients previously diagnosed with major depressive disorder/other forms of depression and generalised anxiety disorder and may or may not be on treatment for the same.
6 Patients undergoing surgery for recurrent or second cancer.
WITHDRAWAL CRITERIA:
Patients needing ICU care for more than 48 hours,post operatively.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The prevalence of anxiety will be reported as proportions with 95% confidence intervals.
|
One day before and 48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the prevalence of depression and to assess the severity of Anxiety and Depression in the postoperative period
2. To study the association between anxiety and depression and the perioperative Pain scores following oncological surgery using Numerical Rating Scale (NRS).
3. To assess the probable causes attributing to perioperative anxiety and depression in oncologic patients.
4. To assess the willingness of the postoperative patients to distraction or relaxation therapy and to correlate the same with their anxiety and depression scores.
|
48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="336"
Sample Size from India="336"
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)
|
07/03/2025 |
| 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="0"
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
|
Anxiety is defined as an unpleasant emotion when a person is in a tense and apprehensive state which arises when a person anticipates danger both internally and externally.
Perioperative anxiety, depression and perioperative pain are two common problems faced by patients undergoing surgery, which are associated with numerous suboptimal postoperative outcomes like delayed healing, increased hospital stay.
This study will investigate the Prevalence of Anxiety and Depression in Oncology Patients in the Perioperative Period. This study will include the patients of age more than 18 years undergoing elective surgery. One day before surgery we will assess the patient for their anxiety,depression and pain scores and shall obtain a written informed consent.Patients fulfilling the inclusion criteria will be assessed again at post operative 48 hours for their scores,and proper medical attention shall be given for the patients with high scores on the scale.
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