| CTRI Number |
CTRI/2024/04/065846 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in patient satisfaction and anxiety levels, undergoing surgery with use of Audio-visual aids. |
|
Scientific Title of Study
|
Effect of Audio-visual aid on Preoperative anxiety and postoperative patient satisfaction in a rural teritiary care center. |
| 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 Vinutha A P |
| Designation |
PG Student |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Science and Research |
| Address |
Department of Anesthesiology,
SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103
Kolar KARNATAKA 562103 India |
| Phone |
8082114033 |
| Fax |
|
| Email |
visionsworld2010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vasudeva Upadhayaya |
| Designation |
Professor |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Science and Research |
| Address |
Department of Anesthesiology,
SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103
Kolar KARNATAKA 562103 India |
| Phone |
9611704281 |
| Fax |
|
| Email |
vasudeva.upadhyaya@smsimsr.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Nikhil M |
| Designation |
Assistant Professor |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Science and Research |
| Address |
Department of Anesthesiology,
SMSIMSR, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103
Kolar KARNATAKA 562103 India |
| Phone |
7411403086 |
| Fax |
|
| Email |
docnikonly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Madhusudan Sai Institute of Medical Science and Research, Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103 |
|
|
Primary Sponsor
|
| Name |
Sri Madhusudan Sai institute of medical science and research |
| Address |
Sri Satya Sai grama, Muddenahalli, Nandi hobli, Chikkaballapur 562103 |
| Type of Sponsor |
Private 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 Nikhil M |
Sri Madhusudan Sai institute of medical science and research |
Pre Anaesthesia check up room no. 25, Department of Anaesthesiology,SMSIMSR,satya sai grama, muddenahalli, nandi hobli, chikkaballapur
562103 Kolar KARNATAKA |
7411403086
docnikonly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Satya Sai University for human excellence |
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 |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American society of anaesthesiology(ASA) 1 & 2, age more than 18 years and less than 60 years undergoing elective surgery under regional anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate
2. Patients who have received anesthesia previously
3. Patients with impaired eyesight or hearing
4. Patients on anxiolytics and antidepressants
5. Patients with existing psychiatric disorder
6. Patients who are health care workers
7. Obstetric patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-operative anxiety using Amsterdam Preoperative Anxiety and Information sale(APAIS) |
1 hour prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction using 5-point Likert scale |
post operative period day one - 24 hours |
|
|
Target Sample Size
|
Total Sample Size="71" Sample Size from India="71"
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)
|
14/05/2024 |
| 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 Applicable |
| 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
|
Majority of patients who are posted for surgery
experience anxiety ¹. A lack of awareness about operation theatre environment
and anaesthetic techniques can cause anxiety 2 , 3. Anxiety
activates stress responses which in turn leads to increased blood sugar levels,
suppression of cellular immune response, raised
oxidative demand,
tachycardia, raised blood pressure, delayed wound healing 4,5.
Patients with anxiety require increased doses of anaesthetics
and analgesics 6. Higher doses of induction agents, longer hospital
stay, and high
incidence of perioperative complications are seen in anxious patients 7.
Therefore, information provided by the anesthesiologist
during the Preanesthetic Interview (PAI) plays a crucial role
in reducing anxiety
and enhances better patient outcome 8.
Pre anaesthetic
interview serves as a good platform to establish patient doctor relationship
which will be helpful for providing information about
anaesthesia. This will bring forth better educated and
informed patients 9. India is a
multilingual country. In rural areas most patients speak regional language and
doctors may not know to communicate in regional language. This language barrier
can cause poor communication, misinterpretation, dissatisfaction, and poor
patient outcome. Not all patients are literate enough to read and understand an
information form. Complexity of these forms may prevent patients from fully
understanding the information provided or patients may simply refuse to read
the material. Nonetheless, written information requires basic literacy skills
and motivation to read the material. With the technological
advances, audio visual aids have become an essential part of our education and
communication.
Incorporating this in our standard health care services can help bridge the
communication gap. It can empower rural
patients with knowledge and understanding of anaesthesia which in turn reduces
anxiety and improve patient satisfaction. Primary aim of the study will be to assess the
impact of standard preanaesthesia verbal instructions versus verbal
instructions and audio-visual aid on anxiety during preoperative period. Secondary aim will be to
assess postoperative satisfaction in both the groups
|