| CTRI Number |
CTRI/2024/03/064560 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing virtual reality to music therapy, along with Midazolam, to see which is better at reducing anxiety in patients getting upper limb nerve blocks. |
|
Scientific Title of Study
|
Randomized comparative study of Virtual reality vs music therapy with Midazolam in decreasing anxiety in patients undergoing upper limb nerve blocks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashank Jain |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No.204,2nd floor,
Department of Anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre,
N.H. 24, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9034453278 |
| Fax |
|
| Email |
shashankjain2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research centre |
| Address |
Room No.204,2nd floor
Department of anaesthesia,
Teerthanker Mahaveer Medical College and Research Centre,
N.H. 24, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor and HOD |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No.204,2nd floor,
Department of Anaesthesia,
Teerthanker Mahaveer Medical College
and Research Centre,
N.H. 24, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College, Moradabad, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre, N.H.-24, Delhi Road, Moradabad-244001, Uttar Pradesh |
| 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 Shashank Jain |
Teerthanker Mahaveer Medical College and Research Centre |
Room No 4, Department of Anaesthesia,Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH |
9034453278
shashankjain2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TEERTHANKER MAHAVEER UNIVERSITY - INSTITUTIONAL ETHICS COMMITTEE |
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 |
Music therapy |
Group 1 will be Music therapy and Usg guided Regional anesthesia will be delivered as per the institution protocol. Before(0mins) and after adminstration (30mins) of upper limb nerve block, STAI-6 tool will be calculated, Hemodynamic parameters (HR,RR,SBP,DBP,MAP,SPO2) will be recorded at time intervals 2,5,10,15,20,25,30 min and thereafter every 15 mins till the completion of surgery |
| Intervention |
Virtual reality (VR) |
Group 2 will be Virtual reality (VR) and Usg guided Regional anesthesia will be delivered as per the institution protocol. Before(0mins) and after adminstration(30mins) of upper limb nerve block, STAI-6 tool will be calculated, Hemodynamic parameters (HR,RR,SBP,DBP,MAP,SPO2) will be recorded at time intervals 2,5,10,15,20,25,30 min and thereafter every 15 mins till the completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient Posted for Upper limb surgeries
2. Written and informed consent
3. Age 18-60 years
4. ASA I- II |
|
| ExclusionCriteria |
| Details |
Patients with any underlying coagulopathy
Patients with significant psychiatric disorders
K/C/O hypersensitivity to local anesthesia
Patients who are extremely anxious (scores
≥50 on the STAI-6 tool)
Possible complications (Headache, Nausea,
Vomiting and Claustrophobia) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare State Trait Anxiety Inventory-6 (STAI-6) between two groups |
Before (0mins) and after adminstration (30mins post procedure) of upper limb nerve block , Anxiety scores based on STAI-6 tool will be calculated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare patient & physician satisfaction scores between two groups
2. To compare communication difficulties between two groups
3. To compare hemodynamic parameters between two groups |
1. Will be monitored based on 10 point visual analogue scale post procedure after 30 mins
2. Will be monitored based on Likert scale after the procedure after 30 mins
3. 2,5,10,15,20,25,30 min & & thereafter every 15 mins till the completion of surgery till the completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/05/2024 |
| 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="3"
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
|
This study is planned in context that Non pharmacological interventions are becoming popular as compared to pharmacological treatments in reducing preoperative anxiety due to their less adverse effects to decrease anxiety and pain experienced by the patients.
After getting approval from Institutional Ethical Committee ( IEC) , those patients who are fit in inclusion criteria will be included in our study.
Anxiety scores will be calculated by the Speilberger’s validated tool, the State trait anxiety invetory score (STAI-6) range from 6 to 24.
Randomization using computer generated random number which are sealed in opaque envelop will be done.
GROUP 1- MUSIC THERAPY GROUP 2- VIRTUAL REALITY
USG guided Regional anesthesia will be delivered as per the institution protocol.
Before and after adminstration of upper limb nerve block , Anxiety scores based on STAI-6 tool will be calculated.
The patient and provider satisfaction scores will be recorded using a 10-point visual analogue scale
Evaluation of communication difficulties between provider and patient will be done by the response based on a 5-point Likert scale
Hemodynamics parameters (HR, RR, SBP, DBP, MAP, SpO2) will be monitored pre operatively,during the procedure every 5 mins and after procedure.
Data will be analyzed using the appropriate statistical method. |