This study is a randomized clinical trial that aimed to investigate the effect of natural sounds on anxiety in patients undergoing coronary artery bypass graft surgery. Research population are patients that hospitalized in cardiac intensive care unit of Shafa hospital affiliated to Kerman University of Medical Sciences for coronary artery bypass graft surgery. Sample size estimated 90 that will select by purposeful method and assign into two groups by minimization method. Intervention included playing music sounds of nature for subjects which was offered in one 30-minute session to intervention group. Control group receive headphone without music. Data collection tools are demographic questionnaire and Spielberger anxiety inventory questionnaire that be completed before and 30 minute post intervention . Finally, data will analyze using descriptive and analytical statistics tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011723190N3
Registration date:2017-03-01, 1395/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of natural sounds on anxiety of patients undergoing coronary artery bypass graft surgery hospitalized in cardiac intensive care unit
Public title
the effect of natural sounds on anxiety of patients undergoing coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients Should be alert and be aware of time and space; Age over 18 years; The patients should for first time had been undergone surgery; During data collection the patients shouldn’t have any pain that causes anxiety as well as they shouldn’t have fever due to organic reason
They shouldn’t use any sedative drug; Do not have a hearing problem and no problem to use headphones; Be able to participate in the research and collaboration; Sign an informed consent form; at least two hours have been left since admission; The patient have no narcotic drug use since morning before practice through any route of administration (oral, sublingual, intravenous and inhalation).
Exclusion criteria: Lack of willingness to collaborate for research; any condition that causes mute the music during work; the need for the use of sedative and narcotic drugs during sound playback or before the completion of the second round of questionnaire.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Central Organization, Imam Ali Blvd, Rafsanjan, Iran
City
Rafsanjan
Postal code
Approval date
2016-12-19, 1395/09/29
Ethics committee reference number
IR.RUMS.REC.1395.117
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
Anxiety
Timepoint
pre test and post test
Method of measurement
state-trait anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Music Sounds of nature that includes work for 30 minutes as recorded by Dr. Sounds Of Nature Arnd Stein in 2011.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital affiliated to Kerman University of Medical Sciences
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsi Zadeh
Street address
Central Organization, Imam Ali Blvd., Rafsanjan, Iran
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PHD, Assistant professor
Other areas of specialty/work
Street address
Jomhouri Street, Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PHD, Assistant professor
Other areas of specialty/work
Street address
Jomhouri Street, Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PHD, Assistant professor
Other areas of specialty/work
Street address
Jomhouri Street, Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)