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CTRI Number  CTRI/2023/10/058277 [Registered on: 04/10/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the pain level and the amount of the anaesthetic agent needed during the Total Knee Replacement in general surgery in patients administered with adjuvant music therapy. 
Scientific Title of Study   Intraoperative music therapy in patients undergoing total knee replacement under general anaesthesia -- A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Edward Lourdes Roshan A 
Designation  PG Registrar 
Affiliation  Christian Medical College 
Address  Department Of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9488242402  
Fax    
Email  roshancuddalure@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Sajan Philip George 
Designation  Professor in Anaesthesiology 
Affiliation  Christian Medical College 
Address  Department Of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8098118456  
Fax    
Email  sajanpg@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Edward Lourdes Roshan A 
Designation  PG Registrar 
Affiliation  Christian Medical College 
Address  Department Of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9488242402  
Fax    
Email  roshancuddalure@gmail.com  
 
Source of Monetary or Material Support  
Institutional Fluid Grant, Christian Medical College & Hospital, Vellore. 
 
Primary Sponsor  
Name  Christian Medical College Hospital 
Address  Institutional Fluid Grant, Department of Anaesthesia, Christian Medical College & Hospital, Vellore, Tamilnadu. PINCODE:632004. 
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 EDWARD LOURDES ROSHAN  Christian Medical College,& Hospital  Paul Brand Operating room and postoperative recovery ward, Department of Anaesthesia Christian Medical College Vellore 632004
Vellore
TAMIL NADU 		 9488242402

roshancuddalure@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD (IRB),CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music over noise cancellation headphones.  Music therapy started just prior to administration of anaesthesia and continued through the surgery duration and stopped just after extubation. The Music used will be ambient nature music(voices of birds, winds), with a frequency range from 432 to 440 hertz. The music will be played in a loop fashion till the patient is extubated. 
Comparator Agent  No music over noise cancellation headphones  Noise cancellation headphones is applied just before administration of anaesthesia and continued through the surgery and removed just after extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient undergoing total knee replacement surgery.
ASA I and ASA II patients(people without any comorbidities or systemic diseases that are under control)
 
 
ExclusionCriteria 
Details  Patients with hearing impairment.
Patients who are non-compliant with the music.
Patients with psychiatric disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The immediate emergent post-operative pain scoring is expected to be significantly lower in the test population (Experimental-group) in comparison to the control subjects (Control-group).  Immediate post-extubation pain scores recorded using a numerical intensity scale will be taken for analysis. 
 
Secondary Outcome  
Outcome  TimePoints 
The intra-operative requirements of the anaesthetic & analgesic agents are expected to be significantly reduced on adjuvant administration of music therapy during the intra-operative period   The vitals[BLOOD PRESSURE, Heart rate, Saturation], Entropy are noted just prior to administration of anaesthesia & thereater at 5, 10,15,30,60,120minutes & just after extubation.The total dose of the various drugs administered to the patient from the point of induction of anaesthesia till the point when the patient is extubated is to be recorded. These details will be used for analysis. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 1 
Date of First Enrollment (India)   09/10/2023 
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="2"
Months="0"
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  

Music can be used as a non-pharmacological  adjuvant with lesser adverse effects in anaesthetic and pain management in the intra-operative and immediate post-operative period.

Pain as defined  by International Association for the Study of Pain is the unpleasant sensory and emotional experience associated with actual or potential tissue damage.

Recent studies emphasise the bi-dimensional nature of pain, comprising of a sensory-discriminative dimension and an affective-motivational dimension.

A systematic review conducted by K. Talbot et al, suggests that the Anterior cingulate cortex(ACC), spino-parabrachio-amygdaloid and spinoparabrachio-hypothalamic areas are to be involved in the affective dimension of the pain.

A trial with the use of remifentanil and the positive suggestions intervention to evaluate pain experienced by patients reveals that by modulating the affective dimension of the pain, the degree of unpleasantness and the pain tolerability can be controlled or manipulated.

A study by Ikonomidou et al. shows that postoperative opioid consumption and perioperative hemodynamic stability are satisfactory in the interventional groups administered music.

 A study done by Jayaraman et al in patients undergoing laparoscopic cholecystectomy revealed a significantly lowered VAS score in the interventional group with music.

 A systematic review and a meta-analysis by Hole J, Hirsch M, Ball E, et al suggest that music acts on the modulation of pain by multifactorial mechanisms, one such is the stimulation of endogenous opioids and by influencing the afferent conduction of the noxious stimulus.

From the above facts, the hypothesis that music influences the affective dimension of pain is to be studied in patients undergoing total knee arthroplasty.

 
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