<?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>IRCT20170607034378N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of massage training on the resilience of pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of telemedicine-based massage training in spouses on the resilience of pregnant women during the Coronavirus pandemic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48008</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Health Center No. 2 of Mashhad was selected from the five centers by cluster sampling method based on a lottery. Then, they were selected from the available health centers that were available and due to the possibility of information leakage, random assignment to two groups of intervention and control based on the names of the centers by lottery. Research units will also be randomly assigned so that mothers whose case number is even.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: . Condition 2: Resilience.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group:  After obtaining the informed consent and completing the research tools in the intervention group, a training session is held on cyberspace. Using a whiteboard, the researcher will teach the "Aflorage" massage technique to the spouses and answer their questions. The participants will be asked to do a back massage by the spouse after establishing a calm environment and the mother's correct position for 10 minutes and each limb for 5 minutes (30 minutes in total). It is also asked to do the massage technique at nights before going to bed, three times a week every other day for 4 weeks (12 times in total). Re-contact is established two weeks after the start of the research. Immediately after the intervention and four days after that, the research tool will be completed. Intervention 2: The control group: No training will be given, and contact will be re-established 2 weeks after the start of the research. Before the intervention, immediately after the intervention, and 4 days after, the research tool will be completed.</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:
Only those parts of the data, such as the information about the main outcome or such things, can be shared.

When:
"Access period starts 6 months after the results are published"

To whom:
Only for researchers working in the academic and scientific institutions

Conditions:
send mail
Identify the person

Where to obtain:
Send email to
jalalmarvif9@gmail.com

How to obtain:
send mail
Identify the person after one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Jalal Marvi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9196685833</zip>
        <telephone>+98 51 3620 4001</telephone>
        <email>jalalmarvif9@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Jalal Marvi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University,Imamamiye Aven,Ghasem Abad, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9196685833</zip>
        <telephone>+98 51 3620 4001</telephone>
        <email>jalalmarvif9@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The informed consent form has been signed.
Iranian and resident of Mashhad.
One fetus in the present pregnancy.
The mother's age is between 18 to 35.
The least literacy of the mother and her husband is about fifth-grade at the elementary school.
She has access to the Internet and WhatsApp.
She lives with her husband.
She has a landline or cell phone number.
The gestational age is between 28 and 34 weeks.
In response to the DASS21 questionnaire, she has obtained less than 10, 14, 17, after depression, anxiety, and stress, respectively.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>An important and horrible event happened to her during the last 6 months.
She has a medical history.
She has a history of infertility or the current pregnancy is a result of infertility treatment.
She or her husband has an addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial medications during the research.
She has had the night shifts at work during the research.
Skin problems such as scorch, skin wounds or bone problems such as fractures in the neck and back or legs.
She has a speech, hearing or accent problems.
She does not have the gynecological problems.
She does the exercise regularly.
She has a history of mental disorder.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group:  After obtaining the informed consent and completing the research tools in the intervention group, a training session is held on cyberspace. Using a whiteboard, the researcher will teach the "Aflorage" massage technique to the spouses and answer their questions. The participants will be asked to do a back massage by the spouse after establishing a calm environment and the mother's correct position for 10 minutes and each limb for 5 minutes (30 minutes in total). It is also asked to do the massage technique at nights before going to bed, three times a week every other day for 4 weeks (12 times in total). Re-contact is established two weeks after the start of the research. Immediately after the intervention and four days after that, the research tool will be completed.</i_keyword>
      <i_keyword>The control group: No training will be given, and contact will be re-established 2 weeks after the start of the research. Before the intervention, immediately after the intervention, and 4 days after, the research tool will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Before the intervention, immediately after the intervention and 4 ِِdays after the intervention. Method of measurement: Connor- Davidson Resilience Scale (CD-RISC).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress-Anxiety-Depression. Timepoint: Before the intervention, immediately after the intervention and 4 days after the intervention. Method of measurement: Stress-Anxiety-Depression scale.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-30</approval_date>
        <contact_name>Ethics committee of Islamic Azad university-mashhad Branch</contact_name>
        <contact_address>Tehran - Ghods Town (West) - Between South Flamek and Zarafshan, Iran TV St. - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
