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CTRI Number  CTRI/2024/07/071113 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intervention using noise cancelling headphones in patients undergoing lower limb surgery]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study how music helps in reducing anxiety in patients undergoing lower limb surgeries under spinal anaesthesia 
Scientific Title of Study   The impact of Binaural beat music and noise cancelling headphones on intraoperative anxiety and pain Catastrophizing in patients undergoing lower limb surgeries under spinal Anaesthesia - A Randomised Controlled study 
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 Preethi S 
Designation  First Year Postgraduate 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology, Main OT complex,Room no.1, 13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.

Pondicherry
PONDICHERRY
605102
India 
Phone  9486782754  
Fax    
Email  preethisaravanane1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radhakrishnan A 
Designation  Professor 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, 13-A,Pondy-Villupuram Main Road, Ariyur, Pudhucherry.
Department of Anaesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, 13-A,Pondy-Villupuram Main Road, Ariyur, Pudhucherry.
Pondicherry
PONDICHERRY
605102
India 
Phone  8825778958  
Fax    
Email  rkpuduvai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhakrishnan A 
Designation  Professor 
Affiliation  Sri Venkateshwaraa Medical College Hospital and Research Centre 
Address  Department of Anaesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, 13-A,Pondy-Villupuram Main Road, Ariyur, Pudhucherry.
Department of Anaesthesiology, Sri Venkateshwaraa Medical College Hospital and Research Centre, 13-A,Pondy-Villupuram Main Road, Ariyur, Pudhucherry.
Pondicherry
PONDICHERRY
605102
India 
Phone  08825778958  
Fax    
Email  rkpuduvai@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr S Preethi 
Address  Sri Venkateshwaraa Medical College Hospital and Research Centre, 13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry, India, 605102. 
Type of Sponsor  Other [Self] 
 
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 Preethi S  Sri Venkateshwaraa Medical College Hospital and Research Centre  Department of Anaesthesiology, Main OT complex, Room no.1, 13-A,Pondy-Villupuram Main Road, Ariyur, Pudhucherry-605102
Pondicherry
PONDICHERRY 		 9486782754

preethisaravanane1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Binaural beat music usage  Patient is subjected to wear a headphone and binaural beat music is played 30 minutes after giving spinal anaesthesia till the end of surgery and the effect of binaural beat music on intraoperative anxiety is studied  
Comparator Agent  Nil  Nil 
Intervention  Noise cancelling headphone usage  Patient is subjected to wear a noise cancellation headphone after 30 minutes of giving spinal anaesthesia till the end of surgery and the effect of noise cancellation on intraoperative anxiety is studied. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  American Society Of Anaesthesiology Class I / II

Patients planned for elective lower limb surgeries 
 
ExclusionCriteria 
Details  Patient refusal
Hearing impairment
Patients having psychiatric disorders and those who are having difficulty in comprehension
Contraindications to spinal anaesthesia
Pregnant and Lactating mothers 
 
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 determine the effect of binaural beat music and active noise cancellation on intraoperative anxiety using State-Trait Anxiety Inventory -6(STAI-6) Score in patients pre and post surgery.  The STAI-6 score will be assessed preoperatively 30 minutes before shifting the patient to OT and postoperatively 2 hours after the surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of music/noise cancellation on patient satisfaction,
sedation,
hemodynamic parameters,
pain catastrophizing and analgesic requirements 		 Preoperatively before shifting to OT, After 30 minutes of spinal anesthesia ( 1min , 15min , 30min , 45min , 60 min, 90min , 120min , 150min , 180min , 210min , 241min) and postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/08/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preethisaravanane1998@gmail.com].

  6. For how long will this data be available start date provided 14-08-2024 and end date provided 04-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Intraoperative anxiety is a challenge in patients undergoing lower limb surgery. An ideal intraoperative anxiety management technique must be effective in repressing the pain catastrophized as well as the chronic pain while having no side effects on the patient.
Such a effect can be brought up with the usage of binaural beat music and noise cancelling headphones. So  the study aims to compare the effect on intraoperative anxiety and pain catastrophizing with the use of binaural beat music , Noise cancelling headphones separately with a control group using none of the above mentioned.
 
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