| CTRI Number |
CTRI/2024/03/064672 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare audiovisual technology as distraction technique with sedatives for treating anxiety for upperlimb surgeries |
|
Scientific Title of Study
|
“Comparison of audiovisual technology versus sedative for anxiety management during procedures under brachial plexus block – A Randomized control trial studyâ€. |
| 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 Kumaran B |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore hospital and MRC |
| Address |
Department of Anaesthesiology,
Jawaharlal Nehru Medical College, Belgavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
8903316733 |
| Fax |
|
| Email |
drkumaranb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedareshvara K.S |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore hospital and MRC |
| Address |
Department of Anaesthesiology,
Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964453463 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KEDARESHVARA KS |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kores hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI.
Belgaum
KARNATAKA
590010
India |
| Phone |
9886375154 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Jawaharlal Nehru Medical College, Belagavi,
Karnataka.
590010. |
|
|
Primary Sponsor
|
| Name |
Dr KUMARAN |
| Address |
Department of Anaesthesiology,
Jawaharlal Nehru Medical College, Belagavi,
Karnataka.
590010. |
| 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 Kumaran |
KLE Dr Prabhakar Kore hospital and MRC |
Department of Anaesthesiology,
Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA |
8903316733
drkumaranb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M65-M67||Disorders of synovium and tendon, (2) ICD-10 Condition: M80-M85||Disorders of bone density and structure, (3) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUDIOVISUAL GROUP |
AFTER GIVING BRACHIAL PLEXSUS BLOCK FOR UPPERLIMB SURGERIES, PATIENT IS PROVIDED WITH AUDIOVISUAL TECHNOLOGY AS A DISTRACTION TO REDUCE ANXIETY |
| Comparator Agent |
MIDAZOLAM OR FENTANYL OR PROPOFOL |
PATIENTS WILL RECIEVE MIDAZOLAM 0.05 MG PER KG OR FENTANYL 1 TO 2 MCG PER KG OR PROPOFOL 1 TO 2 MG PER KG INTRAVENOUSLY AFTER GIVING BRACHIAL BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent |
|
| ExclusionCriteria |
| Details |
Significant Psychiatric disorder such as Generalized Anxiety disorder, Panic disorder, Depression, Psychosis, Bipolar disorder,
Pregnant and or Breastfeeding Patient,
Underlying Coagulopathies,
Infections at the site,
Hypersensitivity to sedatives
History of renal impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate anxiety rating between two groups receiving two different interventions, namely audio visual distraction and sedatives in decreasing anxiety post brachial plexus block administration. |
0 minute (post operative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing hemodynamic parameters in both the groups. |
5minutes, 10minutes, 15minutes, 30minutes, 1hour, 1hour 30minutes.(intra operative) |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/04/2024 |
| 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 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
|
Various audiovisual technologies have been employed to alleviate preoperative anxiety related to invasive/ non invasive medical procedures. The need for this study is to make use of audio visual distraction in relieving both pain and patient’s anxiety through diverting patient’s mind away from the operation theater environment and reducing side effects of sedatives,
|