Determining the effectiveness of mindfulness on perceived stress, anxiety, depression and quantitative EEG parameters in Parkinson's patients
Design
A clinical trial with a control group, with a parallel group of blind evaluators, randomized on 20 patients. In this design, R represents the random assignment of participants in experimental and control groups.
Settings and conduct
This study will be held in Al-Zahra Hospital (S) in Isfahan city, where the evaluator will be blinded and will not know the results of the tests: instructions on how to practice and integrate mindfulness practice in daily activities, audio file containing mindfulness exercises for 45 minutes (meditation, yoga and body scan) along with instructions for daily practice of mindfulness exercises, 8 sessions per week and 1.5 hours per week
Participants/Inclusion and exclusion criteria
Conditions for entering the intervention: patients 40 to 80 years old who have Parkinson's level 1 and 2 and have not received mindfulness training before and a maximum of one year has passed since the diagnosis of the disease.
Conditions for not entering the intervention: patients who are less than 40 years old and more than 80 years old and have been diagnosed with Parkinson's disease for more than a year and at the same time with mindfulness training in educational programs (yoga, meditation) and other sports programs They will attend.
Intervention groups
The experimental group receives interventions related to mindfulness during eight sessions and one 1.5 hour session per week. The control group is without intervention and only pre-test and post-test will be taken from them.
Main outcome variables
Investigating the effect of mindfulness exercises on perceived stress, anxiety, depression and quantitative EEG parameters in Parkinson's patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220816055723N1
Registration date:2022-09-02, 1401/06/11
Registration timing:prospective
Last update:2022-09-02, 1401/06/11
Update count:0
Registration date
2022-09-02, 1401/06/11
Registrant information
Name
Mahshad Moslemzade
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3250 6045
Email address
mahshadmoslemzade70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-07, 1401/06/16
Expected recruitment end date
2022-09-17, 1401/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effective Of Mindfulness On Perceived Stress, Anxiety, Depression and Quantitative Electroencephalogram( EEG ) Parameter's in Parkinson's Patients
Public title
Investigating the effect of mindfulness exercises on Parkinson's patients level 1 and 2
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The neurologist has confirmed their disease and those who have a conscious desire to participate in the intervention sessions will be selected by announcing the call.
As much as possible, the dosage of drugs should be the same during the training period.
The person has not received mindfulness training before.
Committing to participate in MBSR as many class hours (16 hours) and do homework.
have Being 40 to 80 years old
A maximum of one year has passed since the diagnosis of the disease
Consent of the patient and companions for the participation of the patient in the research
Exclusion criteria:
Age less than 40 years and more than 80 years
Patients who have been diagnosed with Parkinson's disease for more than one year.
Simultaneous participation in educational programs (yoga, meditation) and sports programs in line with studying during the course
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to intervention and control groups. The block randomization method will be used for the random allocation of patients. We put the software and then the software itself does it.
Blinding (investigator's opinion)
Single blinded
Blinding description
After allocation, it was not possible to keep the trainer blinded to each participant's allocated intervention, but the assessor remained blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Khorasgan branch
Street address
University Blvd., Arghvanieh Ave,. Eastern Jey Str., Isfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.158
Health conditions studied
1
Description of health condition studied
parkinsons disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
The amount of perceived stress in people with Parkinson's level 1 and 2.
Timepoint
The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after eight weeks of intervention.
Method of measurement
To measure perceived stress, Cohen's Perceived Questionnaire (1983) will used
Secondary outcomes
1
Description
The level of anxiety in people with Parkinson's level 1 and 2
Timepoint
The first session will be taken at the beginning of the intervention and the post-test will be taken eight weeks after the end of the intervention.
Method of measurement
Using Sigmund and Snit Hospital Questionnaire (14 questions) (HADS)
2
Description
The level of depression in people with Parkinson's level 1 and 2
Timepoint
The first session will be taken at the beginning of the intervention and the post-test will be taken eight weeks after the end of the intervention.
Method of measurement
Using Sigmund and Snit Hospital Questionnaire (14 questions) (HADS).
3
Description
Quantitative EEG parameters in people with Parkinson's level 1 and 2
Timepoint
The first session will be taken at the beginning of the Quantitative electroencephalography (qEEG) intervention, and after eight weeks the Quantitative electroencephalography (qEEG ) will be taken again.
Method of measurement
In the recording of quantitative EEG parameters before and after the mindfulness intervention for the experimental and control group (without intervention), the 19-channel device of Mitsar company will be used. In this configuration, the WinEEG software receives the amplified, pre-filtered and digitized electrical signals and stores them on the system's storage memory for further processing.
Intervention groups
1
Description
Intervention group: The intervention group receives interventions related to mindfulness during eight sessions and one 1.5 hour session per week. To facilitate the integration of mindfulness into daily life, instructions are provided on how to practice and integrate mindfulness practice into daily activities such as eating, walking, or doing daily tasks.
Category
Rehabilitation
2
Description
Intervention group: The intervention group receives instructions on using mindfulness to cope with stress in daily life. (The audio file contains mindfulness exercises for 45 minutes (meditation, yoga and body scan) along with instructions for daily practice at home according to the exercises of the sessions and during the course. Time spent in mindfulness exercises It is done weekly for the participants by the mindfulness coach.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra University Hospital
Full name of responsible person
Dr. Ahmad chitsaz
Street address
Isfahan, Shahid Keshvari Highway, Sofe Blvd., Al-Zahra Hospital (S)
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
chitsaz@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiyani
Street address
University Blvd-Arghvanieh Blvd-Eastern Jey St-Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mahshad Moslemzade
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahshad Moslemzade
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 121, Mikhak Building 2, Emami dust Ave, West Jey St, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8199611953
Phone
+98 31 3250 6045
Email
mahshadmoslemzade70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ilnaz sajjadian
Position
Academic Staff. Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd., Arghvanieh Ave,. Eastern Jey Str., Isfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
i.sajjadian@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ilnaz sajjadian
Position
Academic Staff. Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
University Blvd., Arghvanieh Ave,. Eastern Jey Str., Isfahan Town
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
i.sajjadian@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The provided files are in the form of a complete Excel file, in which the patients' history, the level of the disease and the duration of the disease, as well as the drugs used, the underlying diseases, the history of surgery and the history of Parkinson's disease are described. The informed consent form was designed and It will be available to each participant. After completing the intervention steps, a full report of the clinical interventions will be prepared and will be accessible in the file as a document.
When the data will become available and for how long
The Excel file of the participants' profile can be accessed after completion and before the intervention. The informed consent form will be available in the first session after the intervention, when all participants have signed. The clinical interventions file will be in the last session of the intervention and after The result and approval of the relevant judges and professors will be available after printing.
To whom data/document is available
People related to this research will be allowed access. such as supervisors and advisors and referees. Apart from the details of the participants, other researchers working in academic and scientific institutions will have the necessary access.
Under which criteria data/document could be used
Access to all parts of this study will be granted solely for treatment and to supplement and improve research.
From where data/document is obtainable
To access this information, they can refer to the email address i.sajjadian@khuisf.ac.ir and mahshadmoslemzade70@gmail.com.
What processes are involved for a request to access data/document
Applicants can access the information after one working week after entering the email to the entered email address.