<?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>IRCT20241026063502N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-14</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>the effect of guided imagery on the quality of life of women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The impact of guided imagery-based counseling on the quality of life of women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80851</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals in the research community who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to two groups: intervention (33 individuals) and control (33 individuals) using a random number table. The allocation of intervention to individuals will be done randomly using a randomized block design with block sizes of 4, 6, and 8 (utilizing a table of random permutations). The randomization list will be prepared by a statistician. The intervention used in this study will be allocated according to the randomized list by an individual outside the study, who is unaware of the research goals, based on the corresponding codes in sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The test group will undergo eight sessions of group counseling based on guided visualization, led by a researcher who has previously completed a guided visualization counseling course under the supervision of a thesis advisor. After the sessions, they will be provided with a checklist to record the date and time of their exercises daily, marking their progress in the corresponding table. This table will be reviewed weekly by the researcher. The counseling sessions will be held in person for 45 minutes in groups of 5 to 6 participants. The content of the counseling sessions will be derived from relevant sources, supported by research, and developed in consultation with a psychology advisor. The most common duration for psychological interventions is 20 minutes, and the guided visualization sessions will consist of two main parts: 1) relaxation and 2) receiving guided visualization. Initially, relaxation will take place for 10 minutes, followed by the exercise for 20 minutes. After this, participants will share their experiences with their peers for 10 minutes, followed by a 5-minute Q&amp;A session. Participants are asked to practice the techniques presented in each session for 20 minutes a day, six days a week. Intervention 2: Control group: During the research period, no intervention will be done for the control group and they will continue with their daily activities, and in order to appreciate them and in terms of observing the ethical principles, at the end of the research, we will provide them with guided visualization educational pamphlets and a two-hour counseling session based on guided visualization for free.</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:
Part of the data includes information about the main outcome of the sharing.

When:
Access starts 6 months after results are published

To whom:
Researchers working in the university institute

Conditions:
via email

Where to obtain:
Email address: maria.ahmadirad123@gmail.com

How to obtain:
Apply by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maria Ahmadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1، 15 Narges Alley، Farhangian Phase 4</address>
        <city>Ramhormoz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6381766927</zip>
        <telephone>+98 61 4352 7511</telephone>
        <email>maria.ahmadirad123@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maria Ahmadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1، 15 Narges Alley، Farhangian Phase 4</address>
        <city>Ramhormoz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6381766927</zip>
        <telephone>+98 61 4352 7510</telephone>
        <email>maria.ahmadirad123@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 35 years
Known cases of polycystic ovary syndrome based on Rotterdam criteria
At least two years since menarche
A score of more than 26 on the  quality of life questionnaire for women with polycystic ovary syndrome( PCOSQ)
The ability to attend  8 training sessions
Having literacy skills ( reading and writing)
Proficiency in the Persian language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosed physical health  problems and diseases
Use of psychiatric medications
addiction to drugs and alcohol
Simultaneous use of other relaxation methods
Pregnancy and breastfeeding
The occurrence of stress-related events in the past three months (Death of a relative, divorce...)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The test group will undergo eight sessions of group counseling based on guided visualization, led by a researcher who has previously completed a guided visualization counseling course under the supervision of a thesis advisor. After the sessions, they will be provided with a checklist to record the date and time of their exercises daily, marking their progress in the corresponding table. This table will be reviewed weekly by the researcher. The counseling sessions will be held in person for 45 minutes in groups of 5 to 6 participants. The content of the counseling sessions will be derived from relevant sources, supported by research, and developed in consultation with a psychology advisor. The most common duration for psychological interventions is 20 minutes, and the guided visualization sessions will consist of two main parts: 1) relaxation and 2) receiving guided visualization. Initially, relaxation will take place for 10 minutes, followed by the exercise for 20 minutes. After this, participants will share their experiences with their peers for 10 minutes, followed by a 5-minute Q&amp;A session. Participants are asked to practice the techniques presented in each session for 20 minutes a day, six days a week.</i_keyword>
      <i_keyword>Control group: During the research period, no intervention will be done for the control group and they will continue with their daily activities, and in order to appreciate them and in terms of observing the ethical principles, at the end of the research, we will provide them with guided visualization educational pamphlets and a two-hour counseling session based on guided visualization for free.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: "Before starting the study, immediately after, and two weeks after the end of the counseling sessions.". Method of measurement: :Data collection tools include: A: Demographic information questionnaire, which includes personal, medical, and obstetric information such as age, marital status, body mass index, education level of the individual and spouse, employment status of the individual and spouse, number of children, and history of infertility of the individual. B: Quality of life questionnaire for women with polycystic ovary syndrome (PCOSQ).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-21</approval_date>
        <contact_name>Jundishapur University of Medical Sciences, Ahvaz</contact_name>
        <contact_address>Golestan highway-Jandishapur University of Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
