This study is a quasi-experimental, randomized clinical trial that will be done in the patients undergoing open heart surgery admitted in open heart ICU, affiliated to Mazandaran Medical Sciences University. Sixty eligible patients will be randomly divided into two groups. On the day before surgery, the patients in the intervention group will choose their favorite music. After the surgery and 24 hours after admission in ICU, pain intensity (using numerical rating scale and Face scale), heart and respiratory rate, blood pressure, SPO2 and mean arterial pressure (MAP) will be checked and then the patients will listen to their favorite music using Mp3 player & headphones for 30 minutes. The evaluation will be repeated immediately, 30 minutes, and 60 minutes later as well. The patients in control group receive no intervention unless wearing headphone. The measurements will be the same for two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903194133N1
Registration date:2010-05-10, 1389/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-10, 1389/02/20
Registrant information
Name
Amir Emami zeydi
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1322 0294
Email address
r-esmaeili@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-05-10, 1389/02/20
Expected recruitment end date
2010-08-11, 1389/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Music on Intensity of Postoperative Pain, Vital Sign and SPO2 in patients Undergoing Open heart surgery
Public title
Effect of Music on Intensity of Postoperative Pain, Vital Sign and SPO2 in patients Undergoing Open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent, non-emergency open heart surgery, no previous history of heart surgery and having stable hemodynamic status (systolic blood pressure greater than 90 mmHg, the lack of life threatening dysrhythmias and heart rate between 60 to 100 bpm
Exclusion criteria: Need for mechanical ventilation on the time of study, history of psychiatric illness, history of chronic pain, hearing deficit, opiate drug usage 4 hours before the intervention in the ICU, history of playing musical instruments and need to IABP (intraaortic ballon pump), any complication during anesthesia or surgery or the patients dissatisfaction to continuing the study
Age
From 40 years old to 85 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research of Mazandaran University of Medical Sciences
Street address
Deputy of research of Mazandaran University of medical sciences, Moalem Square, Sari
City
sari
Postal code
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
8957
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
Y83,Y84, R
ICD-10 code description
Surgical and other medical procedures as the cause of abnormal reaction of the patient, Acute pain
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before the intervention, immediately after the intervention, 30 minutes after intervention, 60 minutes after intervention
Method of measurement
NRS (numerical rating scale ) and Face scale
2
Description
Vital Sign
Timepoint
Before the intervention, immediately after the intervention, 30 minutes after intervention, 60 minutes after intervention
Method of measurement
Monitoring
3
Description
SPO2
Timepoint
Before the intervention, immediately after the intervention, 30 minutes after intervention, 60 minutes after intervention
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Listening to preoperative patient-selected music, 24 hours after admission to ICU open heart, for 30 minutes through headphones
Category
Other
2
Description
For patients In the control group 24 hours after surgery only headphones without music for 30 minutes will be used
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Amir Emami Zeydi
Street address
Mazandaran Heart Center, Artesh Boulevard, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research of Mazandaran University of medical sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Deputy of research, Mazandaran university of medical sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Mazandaran 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
Nasibe faculty of nursing and midwifery, sari, Iran
Full name of responsible person
Amir Emami Zeydi
Position
student of critical care nursing
Other areas of specialty/work
Street address
Nasibe faculty of nursing and midwifery, Vesal ave., Amir Mazandarani Boulevard,
City
sari
Postal code
Phone
+98 15122673435
Fax
Email
amie_ei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nasibe faculty of nursing and midwifery, sari, Iran
Full name of responsible person
Amir Emami Zeydi
Position
student of critical care nursing
Other areas of specialty/work
Street address
Nasibe faculty of nursing and midwifery, Vesal ave., Amir Mazandarani Boulevard,
City
sari
Postal code
Phone
+98 15122673435
Fax
Email
amie_ei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nasibe faculty of nursing and midwifery, Sari, Iran
Full name of responsible person
Amir Emami Zeydi
Position
student of critical care nursing
Other areas of specialty/work
Street address
Nasibe faculty of nursing and midwifery, Vesal ave., Amir Mazandarani Boulevard,
City
sari
Postal code
Phone
+98 15122673435
Fax
Email
amie_ei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)