| CTRI Number |
CTRI/2021/11/038342 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective cross-sectional |
| Study Design |
Other |
|
Public Title of Study
|
Assessing preoperative anxiety level |
|
Scientific Title of Study
|
Assessment of anxiety among the in-patients of the department of General Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joyel Gigy |
| Designation |
Pharm D Student |
| Affiliation |
NGSM Institute Of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8281247046 |
| Fax |
|
| Email |
joyelgigy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijith S Shetty |
| Designation |
Associate Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of General Surgery, Justice K S Hegde Charitable Hospital, Nitte (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964244284 |
| Fax |
|
| Email |
drabhishetty@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nandakumar UP |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute Of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumarvtkv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru- 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Joyel Gigy |
Justice KS Hegde Charitable Hospital |
Department f General Surgery, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8281247046
joyelgigy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of General Surgery department , aged above 18 years who are scheduled for a surgery. |
|
| ExclusionCriteria |
| Details |
Patients who are a known case of psychiatric illness and are currently receiving treatment
Patients who are unable to clearly communicate that interfere with data collection
Patients undergoing surgery under emergency medical conditions
Patients who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to assess anxiety among patients admitted to the General Surgery ward and have been scheduled for a surgery |
Single |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the association between the anxiety in-patients and demographic variables |
Single |
|
|
Target Sample Size
|
Total Sample Size="267"
Sample Size from India="267"
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)
|
01/12/2021 |
| 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="6"
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
|
INTRODUCTION: Anxiety is a vexatious feeling that compromises the patient’s well-being and comfort.For assessing the intensity of preoperative and postoperative anxiety, different rating scales are considered. Before anaesthesia and surgery, questionnaires involving rating scales are popular means of recording patients & judgements of anxiety. To evaluate the treatment outcome in anxiety disorders, Hamilton Anxiety Rating Scale (HAM-A) was the most commonly used semi-structured assessment scale. OBJECTIVES: • To assess anxiety among patients admitted to the General Surgery ward and have been scheduled for a surgery. • To find out the association between the anxiety in patients and demographic variables. JUSTIFICATION FOR THE STUDY: Anxiety is an unpleasant sensation which compromises the patient’s well-being and comfort. Preoperative anxiety comprises of both the fear of surgery and fear of anaesthesia. Hence, the detection of preoperative anxiety in patients undergoing an operation is very essential in order to be able to alleviate it. METHODOLOGY: The patient data collection form will be designed to collect information pertaining to the socio-demographic characteristics and surgery details of the patient. The Hamilton Anxiety Rating Scale will be utilized to assess the severity of anxiety among the enrolled patients. The association of various socio- demographic variables with the patient’s status of anxiety will also be assessed. STATISTICAL ANALYSIS: Data will be expressed in terms of descriptive statistics( frequency and percentage ) Association will be done using chi-square test or fishcer exact test p- vale< 0.05 will be considered as statistically significant Statistical analysis will be performed using SPSS software version 20.0 OUTCOME MEASURES AND WHETHER IT IS OF NATIONAL SIGNIFICANCE WITH RATIONALE: The study is aimed to carry out effective assessment of the prevalence of anxiety among the patients admitted to the General Surgery department. At the culmination of the study, one will be able to shed light on the distress faced by these patients and highlight the urgent need to address it using suitable intervention in the future. |