| CTRI Number |
CTRI/2019/04/018842 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
28/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To study the role of music on anxiety in patients undergoing surgeries under spinal anaesthesia. |
|
Scientific Title of Study
|
Role of music on perioperative anxiety in patients undergoing surgeries under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nipun Saini |
| Designation |
Junior Resident PG First Year |
| Affiliation |
Junior resident PG 1st year |
| Address |
Department of Anaesthesia
GGS Medical College and Hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878616304 |
| Fax |
|
| Email |
nipun.saini2793@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Department of Anaesthesia
GGS Medical College and Hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nipun Saini |
| Designation |
Junior Resident PG First Year |
| Affiliation |
Junior resident PG 1st year |
| Address |
Department of Anaesthesia
GGS Medical College and Hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9878616304 |
| Fax |
|
| Email |
nipun.saini2793@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GGS Medical College and Hospital |
| Address |
GGS Medical College and Hospital
Faridkot |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gurpreet Singh |
Professor
GGS Medical College and Hospital
Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nipun Saini |
GGS Medical College and Hospital faridkot |
Department of Anaesthesia
Faridkot
PUNJAB |
9878616304
nipun.saini2793@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GGS Medical College and Hospital Faridkot Punjab (India) |
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 |
Standard Operation theatre noise tape |
Standard operation theatre noise tape through noise cancelling headphones for surgeries under spinal anaesthesia |
| Intervention |
Standard relaxation Music |
Standard relaxation music through noise cancelling headphones for surgeries under spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under spinal anaesthesia.
ASA (American Society of Anaesthesiologists) grade I and II.
Age group 18-60 years of either gender, giving valid informed and written consent. |
|
| ExclusionCriteria |
| Details |
Unwillingness to participate in the study (no consent).
ASA grade III and IV patients.
Patients with any contra-indication to spinal anaesthesia.
Patients with hearing impairment.
Known psychiatric or memory disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety by Visual Analogue scale for Anxiety |
Pre-operative,Intra-operative,Post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction by Patient Satisfaction score |
At 24 hours |
| Hemodynamic parameters |
Intra-operative |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized prospective trial to compare the role of music on perioperative anxiety with standard OT noise for 18 months in 70 patients undergoing surgeries under spinal anaesthesia. The primary outcome measure will be anxiety- preoperative, intraoperative and postoperative. The secondary outcome measure will be patient satisfaction at 24 hours and haemodynamic parameters- intraoperative. |