In this randomized clinical trial study after sampling with convenience method, samples with inclusion criteria(patients with myocard Infarction ; out of bed; no restriction for muscles contraction and distenation; being concious; tending to particpate in research and having no mental or psychological disease) will selected and randomly assigned into control and experimental groups. intervention group in one session will learn Progressive Muscle Relaxation method .Intervention group ought to do this technique 120 sessions in 2 months.No intervention for control group is considered. Data collection tools included demographic questionnaire, perceived stress and self-reporting checklist in three phase: before intervention, 1 and 2 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206069664N3
Registration date:2012-07-09, 1391/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-09, 1391/04/19
Registrant information
Name
Mitra Payami Bousari
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6962
Email address
payami@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences and Healt Services
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2012-02-29, 1390/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Progressive Muscle Relaxation and Perceived Stress
Public title
The Effect of Progressive Muscle Relaxation on Perceived Stress of Patients with Myocardial Infarction: A Randomized Clinical Trail
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with myocard Infarction diagnozed by cardiologist; not being complete bed rest; no restriction for muscles contraction and distenation; being concious; tending to particpate in research and having no mental or psychological disease
Exclusion criterion: willing to quit the study
Age
From 18 years old to 77 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Zanjan University of medical sciences and health services
Street address
Zanjan University of medical sciences and health services,Azadi Square
City
Zanjan
Postal code
451544224766
Approval date
2011-10-22, 1390/07/30
Ethics committee reference number
908105
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Received stress
Timepoint
Before intervention 1 and two months after intervention
Method of measurement
Data collection tools included demographic questionnaire, perceived stress and self-reporting checklist.
Secondary outcomes
1
Description
Vital signs (BP,PR,RR)
Timepoint
Before, 1 and 2 months after intervention
Method of measurement
BP(mm/Hg), PR & RR( minutes)
Intervention groups
1
Description
Researcher during 16 weeks with a daily visit to the research environment select patients according to inclusion criteria ,then their personal details are collected. training programs in 7 steps (in a 30-minute session, a) For each sample, is designed and implemented. the program include: identification of muscles and muscle groups targeted, training in relaxation techniques, stages of implementation explain and show it by using progressive muscle action by researcher, responding to questions clients in relaxation techniques, the techniques used by the researcher audio tape, do techniques by patients with the researcher, the difference in feelings of physical and mental After performing at the end of relaxation techniques and supervised by the investigator excercise of this technique by the intervention group in home twice each day for 60 days (120 sessions) and contact person with telephone follow-up was achieved. Visiting scholar at the end of 30th and 60th days to complete a questionnaire to collect data(post test).
Category
Prevention
2
Description
control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Shariati hospital
Full name of responsible person
Amir Vahedian Azimi
Street address
Zanjan, Nursing and Midwifery faculty of Zanjan University of medical sciences and health services
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of medical sciences and health services
Full name of responsible person
Sr. Alireza Biglari
Street address
Zanjan University of medical sciences and health services, Azadi Square
City
Zanjan
Grant name
اعتبارات طرح های پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan university of medical sciences and health services
Full name of responsible person
Amir Vahedian Azimi
Position
Nursing (Ms.)/ Nursing instructor
Other areas of specialty/work
Street address
Nursing and Midwifery faculty of zanjan university of medical sciences and health services, Parvin Etesami Ave.
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2514
Fax
+98 24 1727 0305
Email
vahedian63@zums.ac.irAmirvahedian63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of medical sciences and health services
Full name of responsible person
Mitra payami Bousari
Position
PhD/ assistant professor
Other areas of specialty/work
Street address
Nursing and Midwifery faculty of Zanjan University of medical sciences and health services
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2514
Fax
+98 24 1727 0305
Email
payami@zums.ac.ir, mitra_payami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of medcial sciences and health services
Full name of responsible person
Mitra Payami Bousari
Position
PhD/ assisstant professor
Other areas of specialty/work
Street address
Nursing and Midwifery faculty of Zanjan University of medcial sciences and health services, Parvin Etesami Ave,.
City
Zanjan
Postal code
451786339
Phone
+98 24 1727 2514
Fax
+98 24 1727 0305
Email
payami@zums.ac.irmitra_payami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)