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CTRI Number  CTRI/2024/12/077679 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Cluster Randomized Trial 
Public Title of Study   Study effect of music on anxiety level in female patients undergoing surgery under spinal anaesthesia 
Scientific Title of Study   An Observational study of music therapy on anxiety level in female patients undergoing surgery under spinal anaesthesia 
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 Vaibhavi Hajariwala  
Designation  Professor  
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  Department of Anesthesiology, Pramukh swami medical college, Shree krishna hospital, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaibhavi Hajariwala  
Designation  Professor  
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  Department of Anesthesiology, Pramukh swami medical college, Shree krishna hospital, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Dipak Kalasva 
Designation  2nd year anesthesia resident  
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  Department of Anesthesiology, Pramukh swami medical college, Shree krishna hospital, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  918780040394  
Fax    
Email  dipakbhairk@charutarhealth.org  
 
Source of Monetary or Material Support  
SHREE KRISHNA HOSPITAL, PRAMUKHSWAMI MEDICAL COLLEGE,KARAMSAD, ANAND, GUJARAT,India -388325 
 
Primary Sponsor  
Name  SHREE KRISHNA HOSPITAL  
Address  SHREE KRISHNA HOSPITAL KARAMSAD, ANAND, GUJARAT, India -388325 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaibhavi Hajariwala   Shree Krishna medical hospital  Department of Anesthesiology, Surgical Operation Theater Complex, Anand
Anand
GUJARAT 		 9909977446

vaibhavih@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2, HM Patel Centre for Medical Care and Education - 2, bhaikaka university, karamsad, anand, Gujarat 388325  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of music in females undergoing surgery under spinal anaesthesia  Anxiety levels to be assessed 15 minutes before procedure and 15 minutes after procedure  
Comparator Agent  Effects of music in female patients undergoing surgery under spinal anaesthesia   Not required 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  American Society of Anesthesiologists – ASA grade 1-3
Patients undergoing elective surgeries under spinal anesthesia 
 
ExclusionCriteria 
Details  Patients with contra-indication to sinal anaesthesia
Patients undergoing emergency surgeries
Patients with psychological disorders
Patients with hearing deficits
Patients with cognitive dysfunction 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assess the effect of music on peri-operative anxiety in female patients  15 minutes before and 15 minutes after procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Assess the requirement of sedation in these patients  Every 5 minutes during surgery 
Compare pre-operative & post-operative vitals  Atleast 15 minutes Before & 15 minutes after operation  
Assess patient’s satisfaction score
Assess surgeon’s satisfaction score 		 15 minutes After operation  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   15/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/12/2024 
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 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   Material and method:
2.1 Source of data
After obtaining the ethics committee’s approval, samples collected for a duration of 1 year, from April
2024 to April 2025, atleast 88 patients undergoing elective surgeries requiring spinal anaesthesia in
Shree Krishna hospital, Karamsad, Anand will be included in the study.
2.2 Methodology
 Inclusion criteria
• Females
• Age more than 20 years and less than 60 years
• American Society of Anesthesiologists – ASA grade 1-3
• Patients undergoing elective surgeries under spinal anesthesia
 Exclusion criteria
• Patients undergoing
• Patients with contra-indication to spinal anaesthesia
• Patients undergoing emergency surgeries
• Patients with psychological disorders
• Patients with hearing deficits
• Patients with cognitive dysfunction
Patients posted for surgeries under spinal anaesthesia will be included in this study.
Upon informed consent, patients will be assessed in the recovery room before shifting to the
operation theatre. In the recovery room pre operative vitals of the patient – temperature, pulse,
blood pressure, oxygen saturation, respiratory rate will be marked.
Patients will be asked to rate their anxiety using Visual Analogue Scale for Anxiety (VAS-A)
scale. This was considered as baseline-VAS-A.
For this study, we will provide our own headphones to all patients. The choice of music will
be based on patient’s own choice of music that she prefers. This will be started atleast 10
minutes before shifting to the operating table.
On the operative table, patient will be given sitting position, under all aseptic precaution local
anaesthesia will be given. After giving spinal anaesthesia, patient will be made to give supine
position. After assessment and confirmation of desired spinal anaesthesia effect, patient will be
again started on music via the given headphones till completion of surgery.
During Operation, patients will be assessed if there was any need for intra-operative sedation
requirement.
During operation patient’s VAS-A score will be monitored. If VAS-A score exceeds 4 AND
if the pulse rate exceeds more than 100/min, intra-operative sedation will be started.
The level of Sedation will be decided based on Ramsay Sedation score (21)

After completion of the surgery, patient will be shifted to post-operative care unit. Here, patient
will be asked to rate their anxiety again using VAS-A scale. This will be considered Post-Op
VAS-A.
Patient will be asked her satisfaction level based on Likert scale.
Surgeons will be asked their satisfaction of conducting surgery and will be asked to scale it
according to Likers scale
Baseline and Post-OP VAS-A scale will be compared and assessed if music relieves the anxiety
levels in these patients.
 
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