Protocol summary

Summary
Objective: Aim of this study will be compare the effect of progressive muscular relaxation (PMR) and guided imagery (GI) on quality of life (QOL) in patient undergoing coronary artery bypass graft surgery (CABG). Design: in this single blind (statistical analyzer) randomize clinical trial study, 64 patients schedule for CABG hospitalize in medical educational center of Ayatollah Mousavi, Zanjan University of medical sciences (ZUMS) will recruit using convenience sampling method. Participants will randomly assign to guided imagery group (n=32) and progressive muscle relaxation group (n=32). Setting and conduct: Quality of life will measure using Macnew quality of life questionnaire before CABG and then 2 month after training and doing relaxation by participants. Participants including major eligibility criteria: Patients candidate for coronary artery bypass graft surgery that they have informed consent. Intervention: Doing of progressive muscle relaxation and guided imagery techniques on the seventh day surgery for two month. Main outcome measures: Quality of life

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072512257N5
Registration date: 2016-10-01, 1395/07/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-01, 1395/07/10
Registrant information
Name
Farhad Ramezani-Badr
Name of organization / entity
Zanjan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 24 3527 9412
Email address
ramazanibadr@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effects of guided imagery and progressive muscle relaxation on quality of life in patients undergoing coronary artery bypass graft surgery: A randomized clinical trial
Public title
Comparison between the effects of guided imagery and progressive muscle relaxation on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of coronary artery disease and coronary artery bypass graft surgery candidate for treatment; having written informed consent; having an awareness of time, place and person; ability to learn and perform relaxation. Exclusion criteria: abuse of alcohol and drug and other effective drugs on the psych that is inserted in the patients record; diagnosis of dementia and other mental diseases such as schizophrenia and major depression that is inserted in the patients record; having speech and hearing impairment is detected by researchers; association of other surgery with coronary artery bypass graft surgery such as valve repair surgery; previous training program in the field of study techniques; the inability of the patients to continue collaboration in research.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Zanjan University of medical sciences
Street address
Azadi square, Khorramshar blvd
City
Zanjan
Postal code
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
900410

Health conditions studied

1

Description of health condition studied
coronary artery disease
ICD-10 code
125.1
ICD-10 code description
atherosclerotic heart disease

Primary outcomes

1

Description
quality of life
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Macnew quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Education of Guided imagery technique. Technique will be done from seventh day surgery, twice a day for two months.
Category
Behavior

2

Description
Education of progressive muscle relaxation technique. Technique will be done from seventh day surgery, twice a day for two months.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Street address
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Zanjan University of Medical Sciences
Full name of responsible person
Alireza Biglari
Street address
Azadi sqoare, Khorramshahr blvd
City
Zanjan
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, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Biglari
Position
Associate Professor
Other areas of specialty/work
Street address
Azadi Sq, Khorramshahr Blvd
City
Zanjan
Postal code
Phone
+98 24 3342 0670
Fax
Email
biglari@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zeinab Bahrami Eyvanekey
Position
Instructor
Other areas of specialty/work
Street address
Abhar School of Nursing
City
َAbhar
Postal code
Phone
+98 24 3522 6900
Fax
Email
zeinab.bahrami32@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zeinab Bahrami Eyvanekey
Position
Other areas of specialty/work
Street address
Abhar School of Nursing
City
Abhar
Postal code
Phone
00
Fax
Email
zeinab.bahrami32@gmail.com
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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