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
|
|
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
|
|
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
|
|
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. |