<?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>IRCT20210625051699N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-21</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of relaxation Consultation on Depression and Self-esteem during pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Benson´s relaxation technique and phone Consultation on Depression and Self-esteem among pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61858</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is done in a simple way using a table of random numbers.  In this way, the members of the research will be numbered from 1 to 90 and we will randomly put the number of people from 1 to 90 in the table without any special order.  Then a row and column from the table are randomly selected, the intersection point of the row and column is the starting point of sampling.  From this point, and chosen by the researcher, we determine a direction (for example, up, down, right, or left) to read the table numbers, then we assume specific numbers for each of the study groups.  For example, the numbers 1-30 enter the first intervention group (Benson) and if it is 31-60 the second intervention group (telephone counseling), the numbers 61-90 enter the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: After holding a Benson relaxation training session, mothers are taught using simple and understandable sentences, and in this way, the mother is in the best position in which she feels calm. She sits or lies down, closes her eyes, in which case she chooses a word that always reminds her of peace (such as the word of the god of rain, flowers, etc.) and begins to take deep, regular breaths. It inhales through the nose and exhales through the mouth, repeating the word in the mind with each exhalation. In this position, release the muscles from the toes and continue this work to the upper muscles of the body until all the muscles are fully expanded and maintain this position for 10 to 20 minutes. We then advise the mother to refrain from changing posture immediately after the technique. For more effect, we recommend relaxing music while performing the technique. The intervention group performs exercises for 4 weeks, twice a day, and each time for 15-20 minutes at home. Intervention 2: Intervention group 2:A group receives counseling through counseling with mobile software and remotely (in such a way that during 4 weekly sessions, a 45-60 minute session Related content is held via Skype or What's App), and the content of the counseling is based on the Gamble study counseling model and the strategy of this counseling includes: (Therapeutic communication between midwife and mother, in the first week, mother support and Expressing emotions in the second week, providing information in the third week, reinforcing positive thoughts and discovering appropriate solutions to reduce stress in the fourth week), which is taught to mothers virtually and remotely. Intervention 3: Control group: The control group receives routine pregnancy care.</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 No further information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Hasanpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.31, Azar Ave.,Motahari Blvd., Karaj Town</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3143663471</zip>
        <telephone>+98 21 6551 2606</telephone>
        <email>saharhasanpoor77@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Tork Zahrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>zahranishahnaz@yahoo.co</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mother age 18-35
At least fifth grade literacy
First pregnancy
Gestational age in the third trimester ( 28-34 ) weeks
Single pregnancy
Low risk pregnancy
Having access to the Internet</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of obvious fetal abnormalities
Absence of stressful events (accident, etc.) during the last six months
Absence of mental illness
Not using or addiction to drugs
Not using psychedelics and alcohol
Not having history of infertility and speech and hearing disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, mild</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: After holding a Benson relaxation training session, mothers are taught using simple and understandable sentences, and in this way, the mother is in the best position in which she feels calm. She sits or lies down, closes her eyes, in which case she chooses a word that always reminds her of peace (such as the word of the god of rain, flowers, etc.) and begins to take deep, regular breaths. It inhales through the nose and exhales through the mouth, repeating the word in the mind with each exhalation. In this position, release the muscles from the toes and continue this work to the upper muscles of the body until all the muscles are fully expanded and maintain this position for 10 to 20 minutes. We then advise the mother to refrain from changing posture immediately after the technique. For more effect, we recommend relaxing music while performing the technique. The intervention group performs exercises for 4 weeks, twice a day, and each time for 15-20 minutes at home.</i_keyword>
      <i_keyword>Intervention group 2:A group receives counseling through counseling with mobile software and remotely (in such a way that during 4 weekly sessions, a 45-60 minute session Related content is held via Skype or What's App), and the content of the counseling is based on the Gamble study counseling model and the strategy of this counseling includes: (Therapeutic communication between midwife and mother, in the first week, mother support and Expressing emotions in the second week, providing information in the third week, reinforcing positive thoughts and discovering appropriate solutions to reduce stress in the fourth week), which is taught to mothers virtually and remotely</i_keyword>
      <i_keyword>Control group: The control group receives routine pregnancy care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Measurement of pregnancy's depression score is done before the intervention and immediately after the intervention. Method of measurement: Edinburgh questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-esteem. Timepoint: Measurement of pregnancy's self-esteem score is done before the intervention and immediately after the intervention. Method of measurement: Rosenberg 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-20</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shaid Arabi Ave., Yaman Blvd., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
