<?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>IRCT20230508058119N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Yoga on the Complications of MS.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the Effectiveness of a Course of Yoga Exercises on Depression and Anxiety, Balance and Attention in Patients with MS.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70016</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>In the present study, the Small Sample method is used for community experimentation. In this method, each participant acts as a unit of analysis and serves as their own control group. The method involves serial observations of the sample population, both individually and in groups, before, during, and after the intervention period. The basic design of this classification is based on the ABAB structure, where "A" refers to the baseline phase and "B" indicates the intervention phase.In the first baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. On the first, fourth, eighth, twelfth, and sixteenth days, predetermined tests are conducted and recorded. Generally, these tests are repeated five times during this phase.In the first intervention phase (B), participants engage in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.In the second baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. Tests are conducted and recorded every four days. Generally, these tests are repeated four times during this phase.In the second intervention phase (B), participants participate in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.Throughout all stages (a total of 21 tests), measurements are repeatedly taken and recorded. The data obtained from the conducted tests are transformed into graphical representations, and visual analysis is employed to examine the data within and between phases..</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:
After removing confidential information, participants' data files can be made available to future researchers.

When:
The access period starts 6 months after the results are published

To whom:
Researchers of scientific and academic institutions and related students

Conditions:
Currently, no specific conditions have been determined.

Where to obtain:
To access the data, refer to the email address below.
faezehalibakhshi97@gmail.com

How to obtain:
Currently, no specific conditions have been determined.If necessary, the researcher can contact the email address provided and the details of her/ him service will be provided

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh AliBakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6919753935</zip>
        <telephone>+98 66 4244 4225</telephone>
        <email>faezehalibakhshi97@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faezeh Alibakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6919753935</zip>
        <telephone>+98 66 4244 4225</telephone>
        <email>faezehalibakhshi97@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The examinee does not have the experience of practicing yoga or at least 6 months have passed since her last yoga course
The examinee has the possibility to attend yoga classes</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Inability to Participate in Face-to-Face Yoga Classes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the present study, the Small Sample method is used for community experimentation. In this method, each participant acts as a unit of analysis and serves as their own control group. The method involves serial observations of the sample population, both individually and in groups, before, during, and after the intervention period. The basic design of this classification is based on the ABAB structure, where "A" refers to the baseline phase and "B" indicates the intervention phase.In the first baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. On the first, fourth, eighth, twelfth, and sixteenth days, predetermined tests are conducted and recorded. Generally, these tests are repeated five times during this phase.In the first intervention phase (B), participants engage in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.In the second baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. Tests are conducted and recorded every four days. Generally, these tests are repeated four times during this phase.In the second intervention phase (B), participants participate in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.Throughout all stages (a total of 21 tests), measurements are repeatedly taken and recorded. The data obtained from the conducted tests are transformed into graphical representations, and visual analysis is employed to examine the data within and between phases.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>D2 test score to measure the level of attention. Timepoint: Every 4 days since the beginning of the research. Method of measurement: d2 Attention test.</prim_outcome>
      <prim_outcome>Berg and Bess test score to measure balance. Timepoint: Every 4 days since the beginning of the research. Method of measurement: Berg and Bess balance test.</prim_outcome>
      <prim_outcome>GHQ mental health test score to measure the level of depression and anxiety. Timepoint: Every 4 days since the beginning of the research. Method of measurement: GHQ mental health test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>The financial resources of the research were provided privately.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-01</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Borujerd</contact_name>
        <contact_address>No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad Borujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
