The aim of this study is to determine the effect of music therapy on the comfort of patients undergoing coronary artery bypass surgery. In this clinical trial study, 62 patients who will undergo coronary artery bypass surgery and are hospitalized in hospitals affiliated to Tehran University of Medical Science, after the purposive sampling will be assigned randomly to experiment and control groups. Before the commence of the intervention, patients’ comfort will be measured by using a questionnaire derived from the idea of kolcaba general comfort questionnaire with three physical, environmental and psychological dimensions.
While patients in the control group will be at rest for half an hour in bed, patients in the experiment group will listen to their preferred music that is instrumental and relaxing for half an hour. Finally, once again patients’ comfort will be measured and compared.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT201310234443N6
Registration date:2013-12-04, 1392/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music therapy on comfort of open heart surgery patients
Public title
Effect of music therapy on comfort of patients undergoing open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Undergoing non-emergency open heart surgery for the first time; Age between 30 to 75 years old;
Stabile hemodynamic condition such as systolic blood pressure higher than 90 mmHg, lack of life threatening dysrhythmia and a heart rate between 60 and 100 bpm; Having no mental disorders; Understanding Persian language; Not drug and alcohol addicted; Willingness to hear music; Having no hearing impairment that prevents using headphones; Being conscious and oriented to time, place and person; Undertaking a routine surgical procedure in the operating room such as saphenous vein graft without unexpected events such as severe bleeding or prolong operation; Having no underlying chronic disease that disturb patient comfort such as discopathy.
Exclusion criteria: Suffering from acute complications associated with surgery such as bleeding more than 200cc/h of chest tubes, cardiac tamponade, life threatening dysrhythmias or any emergency condition that requires immediate intervention; Willingness to quit from the study; Death during the study.
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
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Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
1419733171
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
92/د/130/1772
Health conditions studied
1
Description of health condition studied
Heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Comfort
Timepoint
Immediately before and after the clinical trial
Method of measurement
kolcaba General Comfort Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Playing instrumental and relaxing music through headphones for half an hour.
Category
Other
2
Description
Control: Resting on bed for half an hour.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Elyas Soltani
Street address
Imam Khomeini Hospital, Dr Mirkhani St, Tohid Sq
City
Tehran
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Elyas Soltani
Street address
North Kargar St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr Madadi
Street address
Keshavarz Blvd, Central Organization of Tehran University of Medical Sciences
City
Tehran
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elyas Soltani
Position
M.s of Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Dr Mirkhani St, Tohid Sq
City
Tehran
Postal code
1419733171
Phone
+98 21 6694 3187
Fax
+98 21 6690 4252
Email
soltani_75@yahoo.comsoltani.chenar@gmail.com
Web page address
--
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Phd Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Dr Mirkhani St, Tohid Sq
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
+98 21 6690 4252
Email
zakerimo@gmail.com
Web page address
--
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elyas Soltani
Position
Master of Science in critical care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Dr Mirkhani St, Tohid Sq
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
soltani_75@yahoo.comsoltani.chenar@gmail.com
Web page address
--
Sharing plan
Deidentified Individual Participant Data Set (IPD)