<?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>IRCT20220304054178N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-20</date_registration>
      <primary_sponsor>The University of Kordestan</primary_sponsor>
      <public_title>The effects of yoga and music on beta-endorphin, serotonin, body composition, anxiety and depression in obese obese women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of short-term and long-term effects of yoga with music on beta-endorphin, serotonin, body composition, stress and depression of inactive obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63691</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Other design features: The first and second groups practice yoga in the hall air for 23 to 24 degrees Celsius for 6 weeks and three sessions (60 to 90 minutes) per week (18 sessions). After the pre-test, the Hatayoga training program will be performed. Before starting the exercises, the trainer will devote 15 minutes to general warm-up, then 15 to 30 minutes of asanas (physical exercises), pranayama (breathing exercises) and finally 15 minutes, meditation or shavasana (relaxation). will be, Randomization description: To perform the simple randomization method, we used the card shuffling method. In this method, a number of cards selected by the researcher from 1 to 28 were written on each card. For example, by removing the cards, we took out a card and registered its number as the first group and took the card out of the basket, this process until we reach a random sequence according to the sample size (n = 8) for the group. The first continued. The procedure was the same for all groups. In order to hide the random allocation, we used the central randomization method. In this method, the card numbers were given to two yoga instructors in two separate clubs and they were sampled in these two clubs at the same time based on the order of participants's study, and the researcher contacted the relevant clubs about random allocation. The participant asked a specific group, using the telephone.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: 48 hours before the start of training, pre-test evaluations, immediately after the first session of yoga practice with music, the second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of training intervention with We had the music of the third blood draw. Intervention 2: Second intervention group: 48 hours before the start of exercises, pre-test evaluations, immediately after the first session of yoga practice without music, second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of practice intervention without We had the music of the third blood draw. Intervention 3: Third intervention group: 48 hours before training, pre-test evaluations, 48 hours after, immediately after listening to music without training intervention, second blood sampling and finally, to evaluate the long-term effects of music after 6 weeks of blood We had the third one. Intervention 4: Control group: 48 Before the start of the course, we had pre-test evaluations. After 48 hours, we performed a second blood sample and evaluation, and finally, after 6 weeks, we performed a third blood sample or evaluation. This group has no sports activities and continued their daily life.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is In the form of informed consent, the first paragraph was about the confidentiality of patients' personal information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Stareh Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shadab Alley, Sheikh Mazhar St., University Town, Saqez County, Kurdistan Province</address>
        <city>Saqqez</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6681685563</zip>
        <telephone>0098 836248158</telephone>
        <email>starehartan@gmail.com</email>
        <affiliation>The University of Kordestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Shaykh al-Islami Watani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Kurdistan, Pasdaran Boulevard, Sanandaj, Kurdistan</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1517566177</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>d.vatani@uok.ac.ir</email>
        <affiliation>The University of Kordestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obese women with a body mass index equal to or higher than 30 kg per square meter.
Age group 25-45 years.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not having sufficient BMI of the subjects
Lack of interest in yoga and music
Lack of motivation of subjects in performing clinical trials
Not enough time by the subjects to do the test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: 48 hours before the start of training, pre-test evaluations, immediately after the first session of yoga practice with music, the second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of training intervention with We had the music of the third blood draw.</i_keyword>
      <i_keyword>Second intervention group: 48 hours before the start of exercises, pre-test evaluations, immediately after the first session of yoga practice without music, second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of practice intervention without We had the music of the third blood draw.</i_keyword>
      <i_keyword>Third intervention group: 48 hours before training, pre-test evaluations, 48 hours after, immediately after listening to music without training intervention, second blood sampling and finally, to evaluate the long-term effects of music after 6 weeks of blood We had the third one.</i_keyword>
      <i_keyword>Control group: 48 Before the start of the course, we had pre-test evaluations. After 48 hours, we performed a second blood sample and evaluation, and finally, after 6 weeks, we performed a third blood sample or evaluation. This group has no sports activities and continued their daily life.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Beta endorphin. Timepoint: Before the start of the course (48 hours before), 2 days and 42 days after the start of the course. Method of measurement: Human Beta-Endorphin, ELISA Kit.</prim_outcome>
      <prim_outcome>Serotonin. Timepoint: Before the start of the course (48 hours before), 2 days and 42 days after the start of the course. Method of measurement: Human Serotonin, ELISA Kit.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Start of study (before training), end of study (after last training session). Method of measurement: Bioelectric impedance analyzer.</prim_outcome>
      <prim_outcome>Changes in anxiety and depression. Timepoint: Start of study (before training), end of study (after last training session). Method of measurement: Physical, Mental and Social Health Questionnaire, General Health Questionnaire, Eising Self-Esteem Questionnaire, Beck Depression Inventory, Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Changes in depression. Timepoint: Start of study (before training), end of study (after last training session). Method of measurement: Physical, Mental and Social Health Questionnaire, General Health Questionnaire, Eising Self-Esteem Questionnaire, Beck Depression Inventory, Beck Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Obesity. Timepoint: The first measurement before the first blood draw and the last measurement before the third blood draw. Method of measurement: Use of bioelectric impedance analyzer.</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 University of Kordestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-08</approval_date>
        <contact_name>Ethics Committee of Kurdistan University</contact_name>
        <contact_address>No. 4, Shadab Alley, Sheikh Mazhar St., Shahrak Daneshgah St., Saqez, Kurdistan Saqez, Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
