<?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>IRCT20210907052403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of yoga on anxiety and performance of women in the postpartum period</public_title>
      <acronym></acronym>
      <scientific_title>THE EFFECT OF YOGA ON ANXIETY AND FUNCTIONAL STATUS OF NULLIPAROUS WOMEN IN THE POSTPARTUM PERIOD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61787</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocking will be used to balance the number of samples assigned to each of the study groups. The samples are divided into two groups of intervention and control by blocking randomization method and from each center, an equal number of people will be randomly divided into individual units in two groups A and B. The size of all blocks is equal and 36 people in the intervention group and 36 people in the control group will be randomly assigned to the random number table. In the randomization table, the samples are coded and the researcher randomly starts from a table point in the direction of the row or column to select the sample people from the table. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Selects the same number of digits in the row or column direction and then controls the path numbers. The researcher will inevitably encounter two types of numbers, one of which is smaller than the number of the study population and the other is larger than the population. Which only considers and selects smaller numbers. The selected number is in fact the individual code of the community that is selected as a sample. This goes on until a small number can be selected based on the number of sample people. After completing the sample size, the sampling work is completed. Also, blinding is not used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and functional status by doing postpartum yoga movements.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 36 people are in the Intervention group. In this study, yoga exercises to strengthen the minds and bodies of participants virtually in the postpartum period for 10 sessions, each session for 30 minutes for 5 weeks and 2 sessions per week by the researcher.In connection with the intervention group of yoga exercises in the form of online training by the researcher who has passed the postpartum yoga training course, will be uploaded on the site at the appointed time and the site link will be provided to the members of the intervention group. These tutorials can be applied online and offline for users. Skype software will be used to check the correct movement and the researcher will perform the movements visually for the mothers. After making sure that the movements are performed by the mother, the next movement will be uploaded at a specific time and the mother will be asked to Perform the movements calmly and accurately at the appointed time, then the researcher will call the mother to make sure that she performs those movements. Yoga exercises will be performed according to the protocol of Jayashari et al.The process of execution and the type of movements in each session are as follows: 1. Move the bridge2. Move the knee towards the chest3. Exercise one leg forward for the transverse abdominal muscles4- Exercise in hugging (working on the muscles of the upper back)5. Lateral extension exercise (longitudinal stretching of the spine muscles)6- Lying down (to strengthen the muscles of the back and shoulders)7. Strength recovery exercises in the legs and lower abdomen8- Exercise the abdominal and pelvic muscles while sitting on a chair9-Exercise the muscles of the upper back while lying down10-Exercise the abdominal and pelvic muscles while sitting on a chair11-Exercise lateral extension of longitudinal stretch of spinal muscles12-Simple screw drill13. Rotation and twisting in the hand14-Sitting deep screw15. Bend forward on the chairThe movements that will be done in each class are such that the beginning of each class is with a breathing meditation and relaxation, then the above exercises are performed, one repetition from each exercise in the first session and 2 repetitions in the second session, 3 repetitions in the third session. The fourth will be 4 repetitions and in sessions 5 to 10 of each movement will be 5 repetitions. At the end of the exercises, relaxation exercises will be performed. The order of these movements is the same in all sessions and the time spent in that movement (the amount of pause in each movement increases the difficulty of movement) gradually increases during the sessions. Intervention 2: Control group: 36 people are in the control group. In the control group, except for routine actions, no intervention will be performed. Also, if you wish, postpartum yoga exercises will be provided to the control group after the intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre Khakbazan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tohid Square, Dr. Mirkhani St., (Eastern Nosrat), Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4124</telephone>
        <email>khakbaza@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Romina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No8, saba6, 16th alley, sadoghi Ave.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3441653363</zip>
        <telephone>+98 28 3289 7461</telephone>
        <email>s.romina314@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous womenAge 18 to 40 years
Women with uncomplicated natural
childbirthNo known mental illness and use of psychiatric drugs
Has a live baby and no abnormalities
Having physical health according to the mother
On the 10th to the 30th day of the mother's postpartum period
Not participating in other sports classes at the same time
Having and being able to use mobile phones and virtual networks to participate in virtual classes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Up to two sessions of non-participation in yogaReluctance to continue cooperation in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93.42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Activity, yoga</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 36 people are in the Intervention group. In this study, yoga exercises to strengthen the minds and bodies of participants virtually in the postpartum period for 10 sessions, each session for 30 minutes for 5 weeks and 2 sessions per week by the researcher.In connection with the intervention group of yoga exercises in the form of online training by the researcher who has passed the postpartum yoga training course, will be uploaded on the site at the appointed time and the site link will be provided to the members of the intervention group. These tutorials can be applied online and offline for users. Skype software will be used to check the correct movement and the researcher will perform the movements visually for the mothers. After making sure that the movements are performed by the mother, the next movement will be uploaded at a specific time and the mother will be asked to Perform the movements calmly and accurately at the appointed time, then the researcher will call the mother to make sure that she performs those movements. Yoga exercises will be performed according to the protocol of Jayashari et al.The process of execution and the type of movements in each session are as follows: 1. Move the bridge2. Move the knee towards the chest3. Exercise one leg forward for the transverse abdominal muscles4- Exercise in hugging (working on the muscles of the upper back)5. Lateral extension exercise (longitudinal stretching of the spine muscles)6- Lying down (to strengthen the muscles of the back and shoulders)7. Strength recovery exercises in the legs and lower abdomen8- Exercise the abdominal and pelvic muscles while sitting on a chair9-Exercise the muscles of the upper back while lying down10-Exercise the abdominal and pelvic muscles while sitting on a chair11-Exercise lateral extension of longitudinal stretch of spinal muscles12-Simple screw drill13. Rotation and twisting in the hand14-Sitting deep screw15. Bend forward on the chairThe movements that will be done in each class are such that the beginning of each class is with a breathing meditation and relaxation, then the above exercises are performed, one repetition from each exercise in the first session and 2 repetitions in the second session, 3 repetitions in the third session. The fourth will be 4 repetitions and in sessions 5 to 10 of each movement will be 5 repetitions. At the end of the exercises, relaxation exercises will be performed. The order of these movements is the same in all sessions and the time spent in that movement (the amount of pause in each movement increases the difficulty of movement) gradually increases during the sessions.</i_keyword>
      <i_keyword>Control group: 36 people are in the control group. In the control group, except for routine actions, no intervention will be performed. Also, if you wish, postpartum yoga exercises will be provided to the control group after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional status after delivery. Timepoint: Before and 14 days after the intervention. Method of measurement: Functional Status Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and 14 days after the intervention. Method of measurement: Beck Anxiety questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Social Support. Timepoint: Before and 14 days after the intervention. Method of measurement: Perceived Social Support Questionnaire.</sec_outcome>
      <sec_outcome>Breastfeeding. Timepoint: Before and 14 days after the intervention. Method of measurement: Breastfeeding self-efficacy questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-01</approval_date>
        <contact_name>Management of Research and Technology of the University of Tehran</contact_name>
        <contact_address>No. 1, Tehran University of Medical Sciences Headquarters Building, 6th Floor, Room 605, University Research and Technology Management, Keshavarz Blvd Intersection and Ghods St.,Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
