Determining the effect of Mindfulness-Based Stress Reduction on Restless Legs Syndrome in Hemodialysis Patients
Design
A randomized, parallel group, controlled trial
Settings and conduct
The study was designed to "determine the effect of mindfulness-based stress reduction on restless legs syndrome in hemodialysis patients in hospitals affiliated with Kashan University of Medical Sciences."
Participants/Inclusion and exclusion criteria
Inclusion criteria:َ Age range of 18 to 65, lack of peripheral nouropathy, lack of psychiatric illness, full awareness, lack of cognitive disorder, reading and writing skills, Lack of vision and hearing problems, having six months on hemodialysis history.
Exclusion criteria: Under treatment with psychotherapy, Presence of another neurological disease, Iron deficiency anemia, Unconsciousness no restless legs syndrome
Intervention groups
Sixty hemodialysis patients with restless leg syndrome were assigned in control and intervention group randomly.The Mindfulness-Based Stress Reduction group received eight weekly treatments.Each session was 60 min.The sessions were based on Kabat-Zinn protocol.
Main outcome variables
Severity of restless legs syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130721014086N13
Registration date:2020-07-28, 1399/05/07
Registration timing:registered_while_recruiting
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness-Based Stress Reduction on Restless Legs Syndrome in Hemodialysis Patients
Public title
Effect of Mindfulness-Based Stress Reduction on Restless Legs Syndrome in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis patients with restless legs syndrome
Age range 18 to 65
Hb >10 mg/dl
Lack of peripheral nouropathy
Having full awareness
Lack of cognitive disorder like dementia and Alzheimer
Reading and writing skills
Lack of vision and hearing problems
At least 6 months of dialysis history
No psychiatric illness
Exclusion criteria:
Under treatment with psychotherapy
Presence of another neurological disease
Iron deficiency anemia
Unconsciousness
no restless legs syndrome
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned to two groups of intervention and control in the form of four and six blocks.randomization is done by using computer and random digit table.
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
Kashan University of medical Science
Street address
Ghotbe Ravadi, Kashan
City
Kashan
Province
Isfehan
Postal code
88715973474
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.024
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Restless leg syndrome severity
Timepoint
Before study and 1 month later
Method of measurement
International standard restless leg syndrome questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The 8 weekly sessions followed the standard MBSR protocol as developed by Kabat-Zinn (1990). Each session was 60 min. The overall content of the sessions were:1)Introducing mindfulness 2)Sitting Meditation 3)Body Scan and walking meditation 4)yoga 5)Mindfulness of feelings and physical pain, meditation in every day of life 6)Self-reflection and self-management 7)Acceptance and changing 8)How can I take the best care of myself?
Category
Behavior
2
Description
Control group: patients receive usual treatments and educational pamphlets
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zahra Delshad
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 3591
Email
delshad.pari1375@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5557 8011
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lectuerer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 3591
Email
aghajani1362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36115550021
Email
aghajani1362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Email
aghajani_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD