<?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>IRCT20260508069291N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-15</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Counseling Based on the Acceptance and Commitment Model versus the Self-Compassion Model on Quality of Life and Sexual Satisfaction in Women with Human Papillomavirus (HPV)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Counseling Based on the Acceptance and Commitment Model versus the Self-Compassion Model on Quality of Life and Sexual Satisfaction in Women with Human Papillomavirus (HPV)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Research participants will be divided into two intervention groups using random allocation: group counseling based on the Acceptance and Commitment model (n = 30) and group counseling based on the Self-Compassion model (n = 30). The random allocation process consists of two steps:
1. Generating a random allocation to the two intervention groups using Random Allocation software.
2.Concealment: The sequence will be implemented in such a way that the interventions remain concealed until participants are officially assigned to the research groups.
Due to the nature of the topic, objectives, and hypotheses of the study, blinding of participants and intervention facilitators will not be possible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Human Papillomavirus (HPV).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 (Acceptance and Commitment Therapy model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Acceptance and Commitment Therapy model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire. Intervention 2: Intervention group: Group 2 (Self-Compassion model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Self-Compassion model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yazd University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Timsar Falahi Street, Bo Ali Alley</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915818411</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>dr.leilaasadi@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Timsar Falahi Street, Bo Ali Alley</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915818411</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>dr.leilaasadi@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.Positive HPV test 2.Less than 12 months have passed since the positive test result 3.Willingness to participate in the study and complete the informed consent form 4.No diagnosis of another type of sexually transmitted infection (STI) 5.Sexually active (self-reported)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1.Development of HPV-related cancer during the study 2.Absence from more than 30% of sessions (more than two sessions missed) 3.Having a neurological or psychiatric disorder (self-reported)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R87.811</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vaginal high risk human papillomavirus (HPV) DNA test positive</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1 (Acceptance and Commitment Therapy model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Acceptance and Commitment Therapy model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire.</i_keyword>
      <i_keyword>Intervention group: Group 2 (Self-Compassion model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Self-Compassion model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life and sexual satisfaction based on a questionnaire. Timepoint: Before the start of the intervention, immediately after the intervention, and 8 weeks after the completion of the intervention. Method of measurement: Quality of Life and Sexual Satisfaction 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-05</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Timsar Falahi Street, Boali Alley Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
