Determine the effect of progressive muscle relaxation on the quality of life in patients with heart failure
Design
The clinical trial has a community-based and pragmatic control group, with parallel groups, randomized and has 70 samples
Settings and conduct
In this clinical trial, 70 patients who were referred to Amiralmomenin Hospital were selected through available sampling. They were then randomly assigned to control and test groups, and demographic characteristics questionnaire and Minnesota Living with Heart Failure Questionnaire (MLHFQ) were completed for both groups. After 5 sessions of Jacobson progressive muscle relaxation program in the test group and one month follow up, the Minnesota questionnaire was again given to the patients in both groups to complete it.
Participants/Inclusion and exclusion criteria
Patients with heart failure with ejection fraction less than 40%
Intervention groups
The experimental group received an intervention with progressive muscle relaxation and the control group under routine care
Main outcome variables
Improving the quality of life of patients with heart failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180206038650N1
Registration date:2018-02-18, 1396/11/29
Registration timing:prospective
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Samira Rasouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
srasoli@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation on the quality of life of patients with heart failure
Public title
The effect of relaxation on heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a functional level of 3 and 4 based on the category of New York Heart Association
Heart ejection fraction (EF) less than 40%
Exclusion criteria:
Having a known psychiatric disorder
Having Malignant disease and other chronic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
A list of all patients was prepared and numbered within one month from the start of the sampling, which included the criteria for entering the study, giving each patient a certain number. They were then randomly assigned into two groups using the random number table in the sample statistics books.
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 the Islamic Azad University, Tehran Medical Branch
Street address
khaghani st, shariati Ave
City
Tehran
Province
Tehran
Postal code
19395/1495
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IAU.TMU.REC.1396.59
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Quality of Life Score in the Minnesota Questionnaire
Timepoint
Before and one month after the intervention
Method of measurement
Minnesota Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implementation of progressive muscle relaxation in 5 sessions