<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220816055723N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of mindfulness exercises on Parkinson's patients level 1 and 2</public_title>
      <acronym></acronym>
      <scientific_title>The Effective Of Mindfulness On Perceived Stress, Anxiety, Depression and Quantitative Electroencephalogram( EEG ) Parameter's in Parkinson's Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, 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 description: After allocation, it was not possible to keep the trainer blinded to each participant's allocated intervention, but the assessor remained blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>parkinsons disease.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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 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:
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.

Conditions:
Access to all parts of this study will be granted solely for treatment and to supplement and improve research.

Where to obtain:
To access this information, they can refer to the email address i.sajjadian@khuisf.ac.ir and mahshadmoslemzade70@gmail.com.

How to obtain:
Applicants can access the information after one working week after entering the email to the entered email address.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshad Moslemzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 121,  Mikhak Building 2,  Emami dust Ave, West Jey St, Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199611953</zip>
        <telephone>+98 31 3250 6045</telephone>
        <email>mahshadmoslemzade70@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ilnaz sajjadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd., Arghvanieh Ave,. Eastern Jey Str., Isfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>i.sajjadian@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mahshad Moslemzade</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>Ethics Committee of Azad University of Khorasgan branch</contact_name>
        <contact_address>University Blvd., Arghvanieh Ave,. Eastern Jey Str., Isfahan Town Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
