Protocol summary

Summary
The aim of this study was to investigate the effect of progressive muscle relaxation on the anxiety of the myocardial infarction patients. Progressive muscle relaxation program (PMR) is no drug interventions to reduce anxiety in patients. In this method patients continuously contract and then relax their muscles while they are listening to the music in a recorded tape. 76 myocardial infarction patients from Hajar hospital at 2009 were enrolled and randomly assigned to receive 90 sessions of the program for three months. Each session lasted 45 minutes. The primary outcome was anxiety in myocardial infarction patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138905024438N1
Registration date: 2010-10-07, 1389/07/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-07, 1389/07/15
Registrant information
Name
Safar Ali Esmaeili Vardanjani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 2384 2490
Email address
s.esmaeili@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences and Health Services
Expected recruitment start date
2009-12-13, 1388/09/22
Expected recruitment end date
2010-01-05, 1388/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of progressive muscle relaxation on anxiety in patients who have had myocardial infarction
Public title
Effect of progressive muscle relaxation on anxiety in patients who have had myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Presence of myocardial infarction, Willingness to participation, ability to do Progressive Muscle Relaxation Training under physician order, ability to read and write. Exclusion criteria: Presence of other diseases such as mental disorder, past history of participating in an exercise program for rehabilitation of Cardiac problem, cognitive disorder, addiction, or other neurologic disorders, serious skeletal disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
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
Shahrekord University of Medical Sciences and Health Services
Street address
Nursing department, nursing and midwifery college, Rahmatie, Shahrekord
City
Shahrekord
Postal code
8813833435
Approval date
2009-03-12, 1387/12/22
Ethics committee reference number
1223/پ م

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
Anxiety
Timepoint
Baseline and 3 months after intervention
Method of measurement
Estandard Eshpilberger questionnaire

Secondary outcomes

1

Description
Disease symptom
Timepoint
Baseline and 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
For intervantion group Progressive muscle relaxation program: 90 sessions each session 45 minutes for three months. Progressive muscle relaxation program (PMR) is no drug interventions to reduce anxiety in patients. In this method patients continuously contract and then relax their muscles while they are listening to the music in a recorded tape.
Category
Rehabilitation

2

Description
In control group: Routin activities
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Reza Masoodi
Street address
Nursing department, nursing and midwifery college, Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Street address
Nursing department, Nursing and Midwifery college, Rahmatie
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences and Health Services
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
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Safarali Esmaeili Vardanjani
Position
Post graduate student in nursing
Other areas of specialty/work
Street address
Shahrekord, psyciatric sina hospital
City
Shahrekord
Postal code
8813833435
Phone
+98 38 2746 3331
Fax
+98 38 2746 3949
Email
s.esmaeili@khuisf.ac.ir; safar432000@yahoo.com
Web page address
www.skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Position
Member of Faculty and Ph.D student in Nursing
Other areas of specialty/work
Street address
nursing department, nursing and midwifery college, Rahmatie, Shahrekord
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5653
Fax
+98 38 1334 6714
Email
masoodi@skums.ac.ir; masoodi1383@yahoo.com
Web page address
www.skums.ac.ir

Person responsible for updating data

Contact

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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