<?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>IRCT20260205068766N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-23</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acceptance and Commitment Therapy on Sexual Function and Sexual Satisfaction in Pregnant Women</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Acceptance and Commitment Therapy (ACT) on Sexual Function and Sexual Satisfaction in Pregnant Women: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining written informed consent, participants will be randomly allocated to the intervention and control groups using simple randomization based on a random numbers table. The randomization process will be performed by an independent person, Blinding description: Due to the psychological nature of the intervention, blinding of participants and therapists is not feasible. However, data analysis will be performed by a blinded statistician who is unaware of group allocation (single-blind).</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Sexual function and satisfaction problems in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will receive Acceptance and Commitment Therapy (ACT) in an online group format via Skyroom in 4 weekly sessions of 90 minutes. Session content will include acceptance of unpleasant thoughts and emotions, mindfulness, cognitive defusion, self-as-context, values clarification in marital relationships, and committed actions to improve sexual function and sexual satisfaction. Homework will be assigned for each session. Intervention 2: Control group: Participants in this group will receive no psychological or online intervention and will only receive routine prenatal care and standard education at health centers.</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 Due to the sensitive nature of the study topic and the need to protect participants’ confidentiality, individual participant data (IPD) will not be shared.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mohadese Adeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydarieh University of Medical Sciences, Gharani 1 St., Torbat Heydarieh, Khorasan Razavi, Iran.</address>
        <city>Torbat-e Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۵۱۷۶۱۳۵۵۱</zip>
        <telephone>+98 51 5222 6011</telephone>
        <email>dr.mohadese.adelim@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohadese Adeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydarieh University of Medical Sciences, Gharani 1 St., Torbat Heydarieh, Khorasan Razavi, Iran.</address>
        <city>Torbat-e Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۵۱۷۶۱۳۵۵۱</zip>
        <telephone>+98 51 5222 6011</telephone>
        <email>m_a_31661@yahoo.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Singleton pregnancy without serious medical complications
Gestational age between 12 and 24 weeks at enrollment.
Access to the internet and a smart device to participate in online sessions
Willingness and ability to attend all intervention sessions.
Absence of severe or persistent psychiatric disorders.
Provision of written informed consent.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Occurrence of any serious pregnancy complications during the study.
Withdrawal from the study.
Absence from more than one intervention session.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for supervision of normal pregnancy</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>Intervention group: Participants in this group will receive Acceptance and Commitment Therapy (ACT) in an online group format via Skyroom in 4 weekly sessions of 90 minutes. Session content will include acceptance of unpleasant thoughts and emotions, mindfulness, cognitive defusion, self-as-context, values clarification in marital relationships, and committed actions to improve sexual function and sexual satisfaction. Homework will be assigned for each session.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive no psychological or online intervention and will only receive routine prenatal care and standard education at health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function of pregnant women will be measured using the total score of the Female Sexual Function Index (FSFI). Timepoint: Baseline: one day before the intervention Post-intervention: immediately after completion of the intervention Follow-up: two months after the intervention. Method of measurement: The FSFI questionnaire will be completed online, and the total sexual function score will be calculated.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction of pregnant women will be measured using the Larson Sexual Satisfaction Questionnaire. Timepoint: Baseline: one day before the intervention Post-intervention: immediately after completion of the intervention Follow-up: two months after the intervention. Method of measurement: The Larson Sexual Satisfaction Questionnaire will be completed online.</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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-18</approval_date>
        <contact_name>ToTorbat Heydariyeh University of Medical Sciences</contact_name>
        <contact_address>Torbat Heydarieh University of Medical Sciences, Gharani 1 St., Torbat Heydarieh, Khorasan Razavi, Iran. Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
