Randomized controlled trial the effectiveness of Mindfulness-Based Stress Reduction program on Depression, Anxiety and Quality of life of hemodialysis patients
(1) Objectives: This study aimed to evaluate the effectiveness of Mindfulness based stress reduction (MBSR) program on depression,anxiety and quality of life of hemodialysis patients at kashan.(2) Design: General plan of this study is consisted of experimental pre-test and post-test.(3) Setting and conduct: 40 hemodialysis patient who are able to complete the program will be selected by convenient sampling and will be randomly assigned in two groups(treatment as usual hemodialysis group that receiving health education courses and the second group that, in addition to these,receive Mindfulness-based stress reduction program.patients in both groups first be studied for cognitive level by clinical interview and MMSE test and if met the inclusion criteria of study,filled out Hospital Anxiety and depression scale(HADS),quality of life short form-36(SF-36), Mindfulness 15-item questionnaire as pre-test and post- test.(4) Interventions: intervention is consist of courses of health education for both groups and 8 sessions (each session is 120 minutes) of Mindfulness based stress reduction just for experimental group.(5) Main outcome measures: Main outcome measures variables in this research are anxiety, depression,mindfulness and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723652N1
Registration date:2015-09-17, 1394/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-17, 1394/06/26
Registrant information
Name
Mostafa Haghshenas
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
haghshenas2005@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial the effectiveness of Mindfulness-Based Stress Reduction program on Depression, Anxiety and Quality of life of hemodialysis patients
Public title
effectiveness of Mindfulness-Based Stress Reduction program on Depression, Anxiety and Quality of life of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:all of hemodialysis patients at least one year on hemodialysis treatment,at least elementary education level,at least 2 hemodialysis program in week, each hemodialysis duration at least 3 hours,age between 18-60 years,Consent to participate in the study by completing the informed consent form,of both sexes male and female.exclusion criteria:patient unwillingness to stay,suicidal ideation,active psychotic symptoms,Having a categorical diagnosis of psychiatric disorders and Regular medical or psychological treatment,age below 18 and more than 60 year,lack of minimal literacy,severe mental disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
8715988141
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.KAUMS.1394.36
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
2
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
3
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
anxiety
Timepoint
before intervention, After intervention
Method of measurement
hospital anxiety and depression scale
2
Description
depression
Timepoint
before intervention, After intervention
Method of measurement
hospital anxiety and depression scale
3
Description
quality of life
Timepoint
before intervention, After intervention
Method of measurement
short form quality of life SF-36
4
Description
mindfulness
Timepoint
before intervention, After intervention
Method of measurement
Mindfulness 15-item questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Mindfulness Based Stress Reduction; 8 sessions; 2 hours, intervention group