<?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>IRCT20240514061791N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-14</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of group meaning therapy intervention on the psychological well-being of infertile women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of group meaning therapy intervention on the psychological well-being of infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78405</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Purposive sampling will be done in infertility clinic of "Velayat hospital" and  "Jahad daneshgahi" infertility center in Qazvin city. People who have study entry criteria will be registered. Infertile women who have scored less than 54 from the Reef psychological well-being questionnaire and are willing to participate in the study will be randomly allocated to intervention and control groups in the next step. For random allocation, given that there is an intervention method (group meaning therapy) and two control and intervention groups and given that the randomization unit will be individual, random allocation sequence generation application will be used to determine the allocation sequence with binary and quadruple blocks methods. After determining the allocation sequence by binary and quadruple blocks in order to hide the allocation sequence, the sequence of blocks will be written on the papers specifying the group of people (control (C) and intervention (T)) and will be put respectively inside the closed and unspecified envelopes and entered into groups in the same order. If there is a significant difference in the two groups in terms of demographic information, the analysis of covariance test will be used to minimize the difference in the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After replacing the people in the intervention and control groups, people in the intervention group members will be divided into 4 groups of 7 people and one group of 6 people. The meaning therapy intervention will be done in 8 sessions of 90 minutes and one session per week, the first session will be held in person and individually in order to familiarize the members with the researcher, the process and goals of the research. The other sessions will be virtual and group and in application that is available for the participants ("Google meet" or "Qarar" application). In addition to the online meetings, a group will be formed in social media that is available for participants, after each meeting, their questions will be answered in this group. Researcher's personal number will be available for answering personal questions. Generally, intervention group will receive presentation of the content of meaning therapy in virtual form, the educational booklet and other materials as audios and educational videos that will be shared in the group in social media. The content of the sessions is as follows: The first session: Greeting with members, Familiarizing the members with infertility problems and psychological well-being concept, Introducing  intervention "group meaning therapy", Familiarizing the members with the rules of the group. The second session: Creating self-awareness in people, Raising the concept of freedom and authority in life. The third session: Explaining choices responsibility. The fourth session: Recognition of existential anxiety, teaching strategies to deal with anxiety and controlling pessimistic thoughts. The fifth session: Finding meaning from life, Communication with others and Self-development. The sixth session: Examining the meaning of suffering as one of the meaningful aspects of life. The seventh session: Finding meaning through values. Eighth session: Finding meaning through explaining goals and self-improvement, Appreciation and thanks, post-test implementation. The content of the sessions will be presented based on Frankel's meaning therapy approach and Hatzel's plan. Intervention 2: Control group: In this study, the control group receives only the care and routine training of the ward. In order to comply with the ethical standards at the end of the research, the presented content will be available to the control group.</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:
Anonymized coded data, research protocol, outcome information

When:
5 months after the publication of the results until one year

To whom:
Researchers, universities, institutions

Conditions:
Receiving research data and information in order to design new research is unimpeded. Send an email to the responsible person.  Response will be received within two weeks.

Where to obtain:
Send an email to the responsible person.  Response will be received within two weeks.

How to obtain:
Send an email to the responsible person. Response will be received within two weeks.

Comments:
...</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Shokoohifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59811-34197</zip>
        <telephone>+98 21 6625 8677</telephone>
        <email>mahyashokohifard@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Shokoohifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59811-34197</zip>
        <telephone>+98 21 6625 8677</telephone>
        <email>mahyashokohifard@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being Iranian
Suffering from primary infertility due to female causes
Tending to participate in research
Having at least the minimum of  literacy
Gaining a score less than 54 on Reef psychological well-being questionnaire
Having ability to speak and understand Persian (Farsi) language
Having a smartphone and access to the Google meet platform or Qarar application</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>presence of severe marital conflicts (according to the participant)
participating in other psychological intervention sessions during the last six months
Suffering from a known and diagnosed mental illness based on self-report and health records
occurrence of stressful events In the last quarter</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>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After replacing the people in the intervention and control groups, people in the intervention group members will be divided into 4 groups of 7 people and one group of 6 people. The meaning therapy intervention will be done in 8 sessions of 90 minutes and one session per week, the first session will be held in person and individually in order to familiarize the members with the researcher, the process and goals of the research. The other sessions will be virtual and group and in application that is available for the participants ("Google meet" or "Qarar" application). In addition to the online meetings, a group will be formed in social media that is available for participants, after each meeting, their questions will be answered in this group. Researcher's personal number will be available for answering personal questions. Generally, intervention group will receive presentation of the content of meaning therapy in virtual form, the educational booklet and other materials as audios and educational videos that will be shared in the group in social media. The content of the sessions is as follows: The first session: Greeting with members, Familiarizing the members with infertility problems and psychological well-being concept, Introducing  intervention "group meaning therapy", Familiarizing the members with the rules of the group. The second session: Creating self-awareness in people, Raising the concept of freedom and authority in life. The third session: Explaining choices responsibility. The fourth session: Recognition of existential anxiety, teaching strategies to deal with anxiety and controlling pessimistic thoughts. The fifth session: Finding meaning from life, Communication with others and Self-development. The sixth session: Examining the meaning of suffering as one of the meaningful aspects of life. The seventh session: Finding meaning through values. Eighth session: Finding meaning through explaining goals and self-improvement, Appreciation and thanks, post-test implementation. The content of the sessions will be presented based on Frankel's meaning therapy approach and Hatzel's plan.</i_keyword>
      <i_keyword>Control group: In this study, the control group receives only the care and routine training of the ward. In order to comply with the ethical standards at the end of the research, the presented content will be available to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of psychological well-being of infertile women according to Reef psychological well-being questionnaire (PWBS). Timepoint: once before beginning of  study, once immediately after  completion of the intervention, once two months after completion of  intervention. Method of measurement: Reef psychological well-being questionnaire.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-05</approval_date>
        <contact_name>Ethics committee of the Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Qazvin City, Qazvin Province, Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
