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CTRI Number  CTRI/2019/11/022112 [Registered on: 22/11/2019] Trial Registered Prospectively
Last Modified On: 08/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [STUDY GROUP- Hearing of preferred music CONTROL GROUP Only noise cancellation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of music on pain, anxiety and physiological parameters( blood pressure, heart rate)among patients after undergoing open heart surgery patients 
Scientific Title of Study   Effect of music on pain, anxiety and physiological parameters among postoperative sternotomy patients- A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PrabuG 
Designation  M.Sc .Nursing (Medical Surgical ) student 
Affiliation  College of Nursing, JIPMER,Puduchery 
Address  Old Harvey House, Room No- 214, Jawarhlal Institute of Postgraduate Medical Education and Rsearch (JIPMER) , Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442287195  
Fax  0413-2272066  
Email  ganesanprabu8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMJ Kumari 
Designation  Prof cum principal (Ag) & Vice principal 
Affiliation  College of Nursing, JIPMER,Puduchery 
Address  College of Nursing, Jawarhlal Institute of Postgraduate Medical Education and Rsearch (JIPMER),Puduchery

Pondicherry
PONDICHERRY
605006
India 
Phone  9894595420  
Fax  0413-2272066  
Email  kumari_mj@ymail.com  
 
Details of Contact Person
Public Query
 
Name  DrMJ Kumari 
Designation  Prof cum principal (Ag) & Vice principal 
Affiliation  College of Nursing, JIPMER,Puduchery 
Address  College of Nursing, Jawarhlal Institute of Postgraduate Medical Education and Rsearch (JIPMER),Puduchery

Pondicherry
PONDICHERRY
605006
India 
Phone  9894595420  
Fax  0413-2272066  
Email  kumari_mj@ymail.com  
 
Source of Monetary or Material Support  
self funded 
 
Primary Sponsor  
Name  PrabuG 
Address  Old Harvey House, Room No- 214, Jawarhlal Institute of Postgraduate Medical Education and Rsearch (JIPMER) , Puducherry 
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 Kumari MJ  Jawaharlal Institute of Postgraduate Medical Education and Research  147-A,Cardiothoracic- vascular surgery department, CTVS ICU, first floor, super speciality block.
Pondicherry
PONDICHERRY 
9894595420
0413-2272066
kumari_mj@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Human studies) ,JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hearing of preferred music   Hearing of preferred music using noise cancellation head phones by MP3 player for 15-20 minutes for four times a day at four hour interval in day time for first seven post operative days in convenience with patients and staff. 
Comparator Agent  usual routine care with noise cancellation  Only noise cancellation head phones are used without playing any music. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patient’s age over eighteen years with Elective and first time sternotomy patients who recovered from anesthesia and weaned off from ventilator with the signs of stable hemodynamic with the Ability to follow verbal orders and Patients who are willing to participate in the study before the surgery ,in pre operative period.

 
 
ExclusionCriteria 
Details  Patient on continuous infusion of sedatives and analgesic and muscle relaxants drugs after 6 to 8 hours after surgery, patients with hearing problems and Patients on or has cardiopulmonary resuscitation procedure done in operating room or postoperative ICU
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Music may reduce the post operative pain measured by numerical pain rating scale among sternotomy patients through the music   7 days  
 
Secondary Outcome  
Outcome  TimePoints 
Music may also has effect to reduce the anxietyive anxiety scale measured by post operat and stabilizing the physiological parameters of post operative pain among sternotomy patients.  7 days  
 
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)   27/11/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized controlled trial to know the effect of music on post operative pain ,anxiety and physiological parameters among post operative sternotomy patients who are over eighteen years, first time , elective sternotomy patients with stable hemo-dynamics , able to follow the verbal orders with willing to participate. patients who are continious infusion of sedatives or analgesic after 6 to 8 hours of surgery and with hearing problems.informed consent  will be obtained pre-operatively and sample are selected by block randomisation  with sample size of 70( 35 in each of study and control group) and the after the first day of surgery both study and control group will be asseded for pain ,anxiety, physiological parameters before the intervention. the study group will be provided with preferred music by the patient for 15-20 minutes for four times in a day at four hours interval at the convience of patients and staffs using noise cancellation headphones.In control group ,will be provided with only noise cancellation headphones without music for same duration and frequency as mentioned above. Measurement of post operative pain, anxiety and  physiological parameters  after the intervention is measured after seven days of intervention .This study will be conducted in CTVS ICU , super speciality block, first floor, JIPMER ,Puducherry. 
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