| CTRI Number |
CTRI/2024/09/073805 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of musical therapy on hemodynamic parameters and inflammatory markers in patients undergoing surgery for varicose veins under spinal anaesthesia |
|
Scientific Title of Study
|
Effect of musical therapy on hemodynamic parameters and inflammatory markers in patients undergoing surgery for varicose veins under spinalanaesthesia |
| 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 Mohd Pervez Alam |
| Designation |
Postgraduate Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology
Gandhi Memorial and Associated Hospital King George Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7275473274 |
| Fax |
|
| Email |
pervezalam401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajni Gupta |
| Designation |
Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology
Gandhi Memorial and Associated Hospital King George Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839288980 |
| Fax |
|
| Email |
rgkgmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neel Kamal Mishra |
| Designation |
Assistant Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology
Gandhi Memorial and Associted Hospital King George Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415694180 |
| Fax |
|
| Email |
mishraneelkamal83@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Operation theater Department of Anaesthesiology
Gandhi Memorial and Associated Hospital King George Medical University Shahmina Road Lucknow
|
| Type of Sponsor |
Government 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 Mohd Pervez Alam |
Gandhi Memorial and Associated Hospital King George Medical University |
Department of Anaesthesiology Gandhi Memorial and Associated Hospital King George Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH |
7275473274
pervezalam401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I831||Varicose veins of lower extremities with inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MUSIC THERAPY |
patients will be made to listen music by noise cancelling headphones linked to an MP3 player with patient-selected music(blues, classical, country, gospel, jazz, rhythm and blues, rock , soundtrack) and self selected a volume level for 1 hour duration before the surgery and during the surgery. |
| Comparator Agent |
no music therapy |
Control group patients surgery will be begun without any music intervention. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
.All patient of either sex aged above 16 years undergoing varicose vein surgery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
.patients not willing to particepate in the study.
.contraindication for neuraxial anaesthesia.
.having hearing and visual impairement.
.patients with active infection or open wound of the face or eye ,ear area.
.having chronic pain syndrome.
.having mental or psychiatric disorders.
.patient with CAD and DM |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to analyse the effectiveness of music therapy on hemodynamic parameters and inflammatorey markers in patient undergoing varicose vein surgery under spinal anaesthesia. |
After taking patient in operating room baseline hemodynamic parameters will be assessed then every 5 minutes for first 30 minutes, then every 10 minutes till 60 minutes and subsequently every 15 minutes till the completion of surgery. 2 blood sample will be taken first 1 hour before surgery as base line and second at the end of surgery and send to pathology labe for inflammatory markers assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. assessment of state-trait anxiety inventory for state anxiety score.
. assessment of patient satisfaction in postoperative period.
|
. approximately 1 hour before the start of surgery in preop room participant will fill state trait anxiety inventory for state anxiety score.
. patient satisfaction score noted at the end of 4 hours using patient satisfaction score. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
30/09/2024 |
| 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="6"
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
|
after inclusion computer generated randomization will devide patients into two groups control group and music intervention group which will be made to listen music by noise cancelling headphones with the volume lebel as acceptable by patient ,for 1 hour duration of surgery.where as control group patient surgery will be begun without any music intervention after onset of effect of subarachnoid block. there is 3 blood samples will be taken for study of inflammatory markers subsequentely before during and after varicose vien surgery.approximately 1 hour before the start of surgery in preop room participant will fill state trait anxiety inventory for state anxiety score .after taking the patient in operation room standeaed monitoring will be attached and vitals parameters will be assessed initially every 5 minutes for first 30 minute then every 10 minutes till 60 minutes and subsequently every 15 minutes till end of surgery.patient satisfaction score noted at thr end of 4 hours of surgery using patient satisfaction score . |