<?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>IRCT20220820055755N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of implementing emotional release technique on stress and resilience of infertile women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of implementing emotional release technique on stress and resilience of infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65393</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: First, after completing the informed consent form, the participants will complete questionnaires of personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then, the mind release technique training based on the protocol for the participants in 4 sessions and at an interval of 1 week and to Group form will be provided. The first meeting will be held on the day of registration. The first session: introduction of the researcher and clients, introduction of the plan and the way of carrying out the project, explanation about stress, familiarity with infertility, benefits of increasing resilience, familiarity with the process of the impact of stress in the process of infertility treatment, familiarity with the technique of freeing the mind and familiarity with the sensitive points of liberation The mind in the body. The second session: Familiarization with the techniques of freeing the mind, using motivational and positive sentences and giving exercises to women. The third session: Rehearsing the taught techniques and the implementation of the technique by the participant will be implemented in this session. The fourth session: Follow-up of training exercises, checking the status of progress. All the trainings will be done face-to-face at the selected two-clinic in Bandar Abbas city and in a private room. Two weeks after the last session, the questionnaires will be completed again. Intervention 2: Control group: Control group: First, after completing the informed consent form, the participants will complete questionnaires on personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then they will only receive routine care. 6 weeks later, the questionnaires 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Torabi Hefeshjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8th floor, unit 84, eastern block, Setara Ya Didas complex, South Elahia town, Bandar Abbas</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915365168</zip>
        <telephone>+98 76 3437 0206</telephone>
        <email>marziyehtorabi99@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Khairkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr St., above Vanak Square, Rashid Yasmi St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>shivakheirkhah1345@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertility confirmed by a gynecologist
At least one year has passed since the diagnosis of infertility
Not having adopted children
No remarriage
Not suffering from medical diseases unrelated to infertility
No use of drugs in couples
No tension-causing incidents in the past 6 months</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: First, after completing the informed consent form, the participants will complete questionnaires of personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then, the mind release technique training based on the protocol for the participants in 4 sessions and at an interval of 1 week and to Group form will be provided. The first meeting will be held on the day of registration. The first session: introduction of the researcher and clients, introduction of the plan and the way of carrying out the project, explanation about stress, familiarity with infertility, benefits of increasing resilience, familiarity with the process of the impact of stress in the process of infertility treatment, familiarity with the technique of freeing the mind and familiarity with the sensitive points of liberation The mind in the body. The second session: Familiarization with the techniques of freeing the mind, using motivational and positive sentences and giving exercises to women. The third session: Rehearsing the taught techniques and the implementation of the technique by the participant will be implemented in this session. The fourth session: Follow-up of training exercises, checking the status of progress. All the trainings will be done face-to-face at the selected two-clinic in Bandar Abbas city and in a private room. Two weeks after the last session, the questionnaires will be completed again.</i_keyword>
      <i_keyword>Control group: Control group: First, after completing the informed consent form, the participants will complete questionnaires on personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then they will only receive routine care. 6 weeks later, the questionnaires will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infertility stress. Timepoint: Infertility stress measurement is done in the control group at the beginning of the study and 6 weeks later, and in the test group it is done at the beginning of the study and 2 weeks after the last session of emotional release technique training. Method of measurement: In both groups, it will be measured by the researcher using Newton's infertility stress questionnaire.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: Resilience measurement is done in the control group at the beginning of the study and 6 weeks later, and in the test group it is done at the beginning of the study and 2 weeks after the last session of emotional release technique training. Method of measurement: In both groups, it will be measured by the researcher using the Connor and Davidson resilience scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-25</approval_date>
        <contact_name>Working Group/Committee of Ethics in Research of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran Nursing and Midwifery School ,Rashid Yasemi Ave ,Vali-e-Asr Ave ,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
