Protocol summary

Summary
Objective: To determine the effect of music on anxiety and physiological variables in patients with acute coronary syndrome admitted to the coronary care unit, Vali- Asr hospital, Eghlid city. Design: Cross- Sectional study of a clinical trial during the period October 2011 to July 2012 in Vali- Asr hospital, Eghlid city, in coronary care unit on 70 patients who met the study was conducted. Setting and conduct: Patients were randomly divided into two groups, music therapy and control group. In music group two days and 20 minutes a day between the hours of 9-11 am, music with Mp3 Player and headphones for each subject was broadcast. To investigate the physiological state of patient’s respiratory rate uncounted in one minute and in order to control blood pressure and pulse rate were used digital monitor. STAI anxiety questionnaire was completed by patients before and immediately after the intervention. Participants including major eligibility criteria: Inclusion criteria Knowledge of time and place and person, Literate, Stable hemodynamic status during the intervention, allowing the Physician to effluence the music and Exclusion criteria for hearing impaired, ill, being accustomed to listening to music, receiving narcotic drugs 4 hours and tranquilizer 1 hour prior to completing the questionnaire, and unwillingness to participate in the test. Intervention: In the intervention group, music with MP3 Player and headphones for each subject was broadcast. Before the intervention and immediately after the intervention, with anxiety Inventory STAI, patient anxiety was measured and also before the intervention and immediately after the intervention, patients' vital signs were recorded. Main outcome measures (variables): anxiety and vital signs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211207844N2
Registration date: 2013-01-08, 1391/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2011-10-06, 1390/07/14
Expected recruitment end date
2012-07-04, 1391/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of music on anxiety and physiologic variable in patients with acute coronary syndrome admitted to coronary care unit (C.C.U) In Valiasr Hospital, of Eghlid city in 2011- 2012
Public title
Assessment the effect of music on anxiety and physiologic variable in patients with acute coronary syndrome admitted to coronary care unit (C.C.U) In Valiasr Hospital, of Eghlid city in 2011- 2012
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Knowledge of time and place and person; Literate; Stable hemodynamic status during the intervention and allowing the Physician to effluence the music Exclusion criteria: Hearing impaired; Ill; Being accustomed to listening to music; Receiving narcotic drugs 4 hours and tranquilizer 1 hour prior to completing the questionnaire and unwillingness to participate in the test
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Vice chancellor for research, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Postal code
Approval date
2011-10-12, 1390/07/20
Ethics committee reference number
437/90

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
f00-f99
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention and immediately after intervention
Method of measurement
Spiilberger questionnaire

2

Description
Vital sign
Timepoint
Before intervention and immediately after intervention
Method of measurement
Digital manitor device

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, it is not certain
Category
Diagnosis

2

Description
Two hours and 20 minutes a day between the hours of 11-9 am music with Mp3 Player and headphone for each subject were distributed.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital, Eghlid city, Fars province
Full name of responsible person
Seid Alireza Moniri
Street address
Shahid beheshti Blvd, Valiasr hospital, Eghlid city, Fars province
City
Eghlid

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, kerman University of Medical Sciences
Full name of responsible person
Dr. Malekpour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, kerman 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
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour َArab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
kerman
Postal code
7618147867
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
kerman
Postal code
7618147867
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
kerman
Postal code
7618147867
Phone
+98 34 1320 5179
Fax
Email
marab@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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