This study investigates the effect of music on physical, metabolic and psychological responses to stress after heart surgery. A total of 60 inpatients in open heart section participate in this study in two experimental (30 patients) and control (30 patients) groups on the first day after the surgery. All the patients will rest in the bed while receiving oxygen and head of the bed is 20-30 degrees elevated. The patients in the intervention group will listen to a light music using mp3 player through a headphone, from 14 to 14:30 pm. The patients in the control group won’t receive any intervention. Blood pressure, pulse rate, respiratory rate, mean arterial pressure, oxygen saturation, serum cortisol, oxytocin, pain and anxiety levels will be measured at 14, 14:30, and 15 pm and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101045543N1
Registration date:2011-02-16, 1389/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-16, 1389/11/27
Registrant information
Name
Saeide Heidari
Name of organization / entity
School nursing and midwifery, Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1292 4521
Email address
sheidari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music on metabolic, physical and psychological response to stress after cardiac surgery in selected hospitals of Qom, 2010
Public title
The effect of music on metabolic, physical and psychological response to stress
Purpose
Supportive
Inclusion/Exclusion criteria
Exclusion criteria: emergency surgery, having a temporary pacemaker after surgery, surgery after 12 o’clock, previous cardiac surgery, intubated and critically ill patients, treatment with corticosteroids, presence of thyroid gland diseases, presence of adrenal or pituitary (either hypothyroidism or hyperthyroidism), hearing loss, lack of cooperation to participate in the study at any stage of work and lack of orientation to time, person or place
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Nursing Department, School Nursing and Midwifery, Lavasani St., Qom
City
Qom
Postal code
3756/37185
Approval date
2010-10-21, 1389/07/29
Ethics committee reference number
12050/34/پ
Health conditions studied
1
Description of health condition studied
Responses physical, psychological and metabolic stress in patients undergoing heart surgery
ICD-10 code
F43-0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Oxytocin level
Timepoint
Three times, once every 30 minutes
Method of measurement
Laboratory tests
Secondary outcomes
1
Description
Cortisol level
Timepoint
Three times, once every 30 minutes
Method of measurement
Laboratory test
2
Description
pain intensity
Timepoint
Three times, once every 30 minutes
Method of measurement
Visual pain assessment scale
3
Description
anxiety
Timepoint
Three times, once every 30 minutes
Method of measurement
Visual Anxiety Scale
4
Description
Oxygen saturation
Timepoint
Three times, once every 30 minutes
Method of measurement
palse oximetry
5
Description
mean arterial pressure
Timepoint
Three times, once every 30 minutes
Method of measurement
sphygmomanometer of monitoring system
6
Description
respiratory rate
Timepoint
Three times, once every 30 minutes
Method of measurement
Physical Examination
7
Description
pulse rate
Timepoint
Three times, once every 30 minutes
Method of measurement
Physical Examination
8
Description
blood pressure
Timepoint
Three times, once every 30 minutes
Method of measurement
sphygmomanometer of manitoring
Intervention groups
1
Description
The patients will rest in the bed while receiving oxygen and head of the bed is 20-30 degrees elevated and listening to a light music using mp3 player through a headphone, from 14 to 14:30 pm.
Category
Rehabilitation
2
Description
The patients will rest in the bed while receiving oxygen and head of the bed is 20-30 degrees elevated.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Saeide Heidari
Street address
Shahid Beheshti hospital, Beheshti St., Qom
City
Qom
2
Recruitment center
Name of recruitment center
Valiaser hospital
Full name of responsible person
Saeide Heidari
Street address
Islamic Republic St., Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Koohpayee
Street address
Nursing Department, School Nursing and Midwifery, Lavasani St., Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
Saeide Heidari
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing Department, School Nursing and Midwifery, Lavasani St., Qom
City
Qom
Postal code
Phone
+98 25 1770 4233
Fax
Email
sheidari@muq.ac.ir heidari_saeide@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Saeide Heidari
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing Department, School Nursing and Midwifery, Lavasani St., Qom
City
Qom
Postal code
Phone
+98 25 1770 4233
Fax
Email
sheidari@muq.ac.ir heidari_saeide@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery- Qom University of Medical Sciences
Full name of responsible person
Saeide Heidari
Position
Master of nursing- faculty
Other areas of specialty/work
Street address
Nursing Department, School Nursing and Midwifery, Lavasani St., Qom
City
Qom
Postal code
Phone
+98 25 1770 4233
Fax
Email
sheidari@muq.ac.irheidari_saeide@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)