<?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>IRCT20220712055447N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-23</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of online emotion regulation therapy with online guided imagery therapy on marital stress in women undergoing amniocentesis</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness comparison of online emotion regulation therapy program versus online guided imagery therapy on marital stress in women undergoing amniocentesis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After obtaining the ethics committee code and registration in the IRICT system, the researcher will go to the Yazd Perinatal Clinic and after introducing himself and explaining the process and objectives of the research with the help of the third moderator, he will call and invite the women candidates for amniocentesis to study. takes In this way, among the women undergoing amniocentesis, the number of 64 people who met the entry criteria was selected and a code from 1 to 64 was assigned to each of them, and by using the online software (using www.random.org /sequences/) Patients are assigned to two groups, ERT and GIT (32 people each) according to the output of the software. Again, each group is randomly divided into 2 subgroups of 16 people each.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The content of the meetings includes; Session 1: Getting to know and communicating with each other, Session 2: Choosing a situation, Session 3: Choosing a situation, Session 4: Modifying a situation, Session 5: Expanding attention, Session 6: Cognitive evaluation, Session 7: Adjusting the response, Session 8: Evaluation and It is application. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed and the tasks related to the previous session are reviewed by the counselor in order to evaluate the improvement of marital stress in each session. Women are asked to participate in online counseling discussions and ask questions. At the end of each session, a summary of the important topics discussed is presented and the questions of the participants are answered and the participants are asked to do their homework until the next session. After the completion of the training sessions, a post-test will be conducted for both groups in the last session, and a follow-up test will be conducted in both groups one month after the completion of the treatment sessions.The intervention is done online in the Sky Room and WhatsApp as a group in the form of 8 60-minute sessions, once a week, by a senior student of counseling in midwifery under the supervision of a supervisor and a couple therapy consultant. Intervention 2: Intervention group 2:  The contents of the sessions include: session 1: preparation of the therapist, treatment situation and clients, session 2: background exercises for mental imagery in order to stimulate mental images, session 3: relaxation background exercise before mental imagery to prepare for creating mental images Session 4: Evoking mental images and describing them, Session 5: Facilitating new adaptive skills through mental imagery by expanding the mental images of working on these images and trying to make changes in these images, Session 6: Ending the stage of working on mental imagery. In the therapy session, session 7: follow up work with mental images, including reflections, thoughts, interpretations and creating meanings, session 8: presentation of homework and review of materials and re-completion of questionnaires. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed and the tasks related to the previous session are reviewed by the counselor in order to evaluate the improvement of marital stress in each session. Women are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for the participation of more people in the meeting. At the end of each session, a summary of the important topics discussed is presented and the questions of the participants are answered and the participants are asked to do their homework until the next session. After the completion of the training sessions, in the last session, the post-test will be performed and again, a month after the completion of the treatment sessions, the follow-up test will be performed.The intervention is carried out online in Sky Room and WhatsApp as a group in the form of 8 sessions of 60 minutes, once a week, by a senior student of counseling in midwifery under the supervision of a supervisor and a couple therapy consultant.</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:
All personal data of study participants can be shared after de-identification

When:
After results publication

To whom:
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.

Conditions:
Scientific usage

Where to obtain:
farajkhoda@yahoo.com

How to obtain:
One week after receiving the applicant's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boualiave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave</address>
        <city>Yaza</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married healthy pregnant women willing to undergo amniocentesis
Gestational age 20 weeks based on the pregnancy record
Cases in which the screening was positive or abnormality was seen in the ultrasound
The ability to have sex one week after amniocentesis with the permission of the attending physician
The ability to use online counseling using a smartphone and having an Android or iOS smartphone
Willingness to participate in the study
Having marital stress based on marital stress questionnaire
Having sex with your spouse</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having mental disorders and being treated for mental disorders
Participating in another concurrent study
Receiving psychological treatment at the time of entering the study
Having pregnancy-related disorders
Suffering from systemic diseases based on pregnancy records</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific (isolated) phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The content of the meetings includes; Session 1: Getting to know and communicating with each other, Session 2: Choosing a situation, Session 3: Choosing a situation, Session 4: Modifying a situation, Session 5: Expanding attention, Session 6: Cognitive evaluation, Session 7: Adjusting the response, Session 8: Evaluation and It is application. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed and the tasks related to the previous session are reviewed by the counselor in order to evaluate the improvement of marital stress in each session. Women are asked to participate in online counseling discussions and ask questions. At the end of each session, a summary of the important topics discussed is presented and the questions of the participants are answered and the participants are asked to do their homework until the next session. After the completion of the training sessions, a post-test will be conducted for both groups in the last session, and a follow-up test will be conducted in both groups one month after the completion of the treatment sessions.The intervention is done online in the Sky Room and WhatsApp as a group in the form of 8 60-minute sessions, once a week, by a senior student of counseling in midwifery under the supervision of a supervisor and a couple therapy consultant.</i_keyword>
      <i_keyword>Intervention group 2:  The contents of the sessions include: session 1: preparation of the therapist, treatment situation and clients, session 2: background exercises for mental imagery in order to stimulate mental images, session 3: relaxation background exercise before mental imagery to prepare for creating mental images Session 4: Evoking mental images and describing them, Session 5: Facilitating new adaptive skills through mental imagery by expanding the mental images of working on these images and trying to make changes in these images, Session 6: Ending the stage of working on mental imagery. In the therapy session, session 7: follow up work with mental images, including reflections, thoughts, interpretations and creating meanings, session 8: presentation of homework and review of materials and re-completion of questionnaires. At the beginning of each session, a summary of the materials related to the previous sessions is reviewed and the tasks related to the previous session are reviewed by the counselor in order to evaluate the improvement of marital stress in each session. Women are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting for the participation of more people in the meeting. At the end of each session, a summary of the important topics discussed is presented and the questions of the participants are answered and the participants are asked to do their homework until the next session. After the completion of the training sessions, in the last session, the post-test will be performed and again, a month after the completion of the treatment sessions, the follow-up test will be performed.The intervention is carried out online in Sky Room and WhatsApp as a group in the form of 8 sessions of 60 minutes, once a week, by a senior student of counseling in midwifery under the supervision of a supervisor and a couple therapy consultant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of mean marital stress scores in women undergoing amniocentesis. Timepoint: Baseline, end of intervention at week 8, follow-up at end of study at week 12 in both groups. Method of measurement: Marital stress questionnaire (Omoluabi 1994).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spouse's satisfaction with marital relationship from woman's point of view. Timepoint: Baseline, end of intervention at week 8, follow-up at end of study at week 12. Method of measurement: On the visual scale, the ten-point scale is measured between 1 and 10 with a question from the woman.</sec_outcome>
      <sec_outcome>The occurrence of premature birth. Timepoint: 12 week follow-up. Method of measurement: With a question about the frequency of premature birth, in the questionnaire, it is measured in the 12th week follow-up in two groups.</sec_outcome>
      <sec_outcome>Premature rupture of the water sac. Timepoint: 12 week follow-up. Method of measurement: With a question about the frequency of rupture of the water sac in the questionnaire, it is measured in the 12th week follow-up in two groups.</sec_outcome>
      <sec_outcome>Abnormality in the baby in case of premature delivery. Timepoint: 12 week follow-up. Method of measurement: With a question about the frequency of Abnormality in the baby in case of premature delivery in the questionnaire, it is measured in the 12th week follow-up in two groups.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-08</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Bahonar Square، Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
