Determining the impact of Mindfulness on quality of life among individuals with Parkinson’s disease
Design
This study is a randomized parallel-group clinical trial with control group which is done On 40 patients with Parkinson's disease
Settings and conduct
This study will be conducted at Tabriz health centers.
The sample size in this clinical trial is 40 and the study population is consisted of Parkinson patients,That these patients will be divided into two control (20 patients) and Intervention groups (20 patients) using table of random numbers.
All of the patients will receive usual medication too. The patients in Mindfulness Based Stress Reduction group are participated in 8 therapy sessions. Participants of both groups will fill out the 39-Item Parkinson's Disease Questionnaire (PDQ-39) Before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of Parkinson's Disease based on the UK Brain Bank Criteria;
Patients with Hoen and Yahr degree of 1-3;
Regular treatment of Parkinson's disease with the related drugs.
Non inclusion criteria :
The need to adjust the dose of Parkinson's drug in the last three months (before entering the study);
Having an unstable or life-threatening illness.
Intervention groups
Intervention group:
The intervention in this study will be two-hour Mindfulness sessions which will be held weekly for 8 weeks. These meetings will be held in the groups of 4 to 5 people.
Control group :
In the control group, the routine treatment of patients will continue.
Main outcome variables
PDQ-39 index score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181007041258N1
Registration date:2018-11-20, 1397/08/29
Registration timing:retrospective
Last update:2018-11-20, 1397/08/29
Update count:0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Reza Rikhtehgarghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 3374
Email address
rikhtehgar.r@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-10-26, 1397/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Mindfulness with usual parkinson treatment on quality of life among individuals with Parkinson’s Disease
Public title
Effect of Mindfulness in Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Parkinson's Disease based on the UK Brain Bank Criteria.
Patients with Hoen and Yahr degree of 1-3
Regular treatment of Parkinson's disease with related drugs
Exclusion criteria:
The need to adjust the dose of Parkinson's drug in the last three months (before entering the study)
Having an unstable or life-threatening illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The tool for randomization in this study was statistical software
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
Tabriz University of Medical Sciences
Street address
Golgasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.TBZMED.REC.1397.551
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
PDQ39 index
Timepoint
before and 8 weeks after intervention
Method of measurement
PDQ39 standard questionnaire
Secondary outcomes
1
Description
PDQ39 index score
Timepoint
8 weeks later
Method of measurement
Standard questionnaire
Intervention groups
1
Description
Intervention group : will complete eight sessions of the Mindfulness course in two months (every week a two-hour session) . In first to fourth sessions, the main techniques are taught based on mindfulness, including mindfulness of body feeling , practicing of physical inspection, mindfulness of breathing, body, sounds and objects, mindfulness of daily activities, trying to look or listen for five minutes and mindfulness of mental events (focus on thoughts as irrational beliefs, focus on the emotions as experience of the anxiety caused by irrational belief and mental images, and finally learn how anxiety and worry influence on daily treatment by different exercise). In the fifth to eighth sessions, while continuing the review of previous practice, other techniques, such as mindfulness training related mood, thoughts, attitudes, thought and feelings practice and pleasant and unpleasant events calendar will be taught.
Category
Behavior
2
Description
Control group: Control group will receive the usual Parkinson treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Neda Ghaemian
Street address
Daneshghah street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3334 0730
Email
nedaqman@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neurosceinces Research Center
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3334 0730
Email
nsrc2008@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Ghaemian
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Neurosceinces Research Center , Imam Reza hospital ,Azadi Street
City
ُTabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3334 0730
Email
nedaqman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Ghaemian
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Neurosceinces Research Center, Imam Reza hospital, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3334 0730
Email
nedaqman@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Ghaemian
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Neurosceinces Research Center, Imam Reza hospital, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3334 0730
Email
nedaqman@gmail.com
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