<?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>IRCT20170611034452N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-07</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>the effect of brief Mindfulness-based Cognitive Therapy (b-MBCT) on the  married women’s body image and quality of sexual life after hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of brief Mindfulness-based Cognitive Therapy (b-MBCT) on the  married women’s body image and quality of sexual life after hysterectomy in Kerman, 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: simple individual randomization through randomization table of random numbers. allocation concealment will be done, Blinding description: Intervention group samples do not meet with control group samples at any point in the study, so the probability of individuals in the intervention group being in control is very low and information exchange is not likely to occur. for data analyzer we send the data to him/her without mentioning intervention and control group and instead we will label them with A and B. for data and safety monitoring board we will not aware them about the group of intervention as it is possible only if they request for checking the accuracy of the intervention. for outcome assessor, they only asked the posttest questions by telephone without being aware that which woman is in which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hysterectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention as a Mind-Based Cognitive Counseling Short-Awareness on Body Image After Hysterectomy. intervention is brief-mindfulness based cognitive therapy for women between 2 months to 2 years after their hysterectomy (4 sessions 120 minutes).The sessions will hold in the hospital they undergone hysterectomy or any other places that they are eager to be hold.                                                                                          content of counseling sessions:                                                                                 first session: greeting and definition of sessions rules, definition of b-mbct, body image,  quality of sexual life and related factors among women undergone hysterectomy, stress and mindfulness. body scan technique, home work                                                                                           session two: review of previous session, influence of our interpretation of our emotions, self-awareness and body-awareness, focus on breathing, hearing and vision, homework                                                                             session 3: definition of cognitive errors, negative and positive thoughts, mindful walking, homework                                                                                     session 4: influence of love. though acceptance automatic pilot, mountain meditation, homework. Intervention 2: Control group: َAfter the intervention they can attend the sessions.</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:
Data on the main outcomes of the research after the completion of research work can be published.

When:
Data on the main outcomes of the research after the completion of research work can be published.

To whom:
Starting access to the data above is immediately after publishing the results.

Conditions:
Researchers in academia and scientific institute are able to access research data.

Where to obtain:
atefeahmadi59@gmail.com monashirzad1992@yahoo.com

How to obtain:
پس از ارسال درخواست کتبی از جانب متقاضی، داده ها در اسرع وقت در اختیار ایشان قرار خواهد گرفت

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Bahador</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First of the Haft Bagh Alavi-Pardis of Kerman University of Medical Sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 913 295 6143</telephone>
        <email>elahebahador6466@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman-first element of the Haft Bagh Allavi-Pardis of kerman  University</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76169-13555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>a.ahmadi@kmu.ac .ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sample subjects at least two months after their hysterectomy
Married
Ability to self-perceive self
Not attending in counseling sessions for her psychological problems during this study
No self-report drug, stimulant and alcohol dependence
Primary literacy
Not suffering from chronic illnesses
No medication Psychiatry
surgery are younger than 65.
must be at least 2 years since the hysterectomy
sexually active with her husband</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Do not attend two or more counseling sessions
Not willing to countinue participating in the study while doing research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z90.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acquired absence of genital organ(s)</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:Intervention as a Mind-Based Cognitive Counseling Short-Awareness on Body Image After Hysterectomy. intervention is brief-mindfulness based cognitive therapy for women between 2 months to 2 years after their hysterectomy (4 sessions 120 minutes).The sessions will hold in the hospital they undergone hysterectomy or any other places that they are eager to be hold.                                                                                          content of counseling sessions:                                                                                 first session: greeting and definition of sessions rules, definition of b-mbct, body image,  quality of sexual life and related factors among women undergone hysterectomy, stress and mindfulness. body scan technique, home work                                                                                           session two: review of previous session, influence of our interpretation of our emotions, self-awareness and body-awareness, focus on breathing, hearing and vision, homework                                                                             session 3: definition of cognitive errors, negative and positive thoughts, mindful walking, homework                                                                                     session 4: influence of love. though acceptance automatic pilot, mountain meditation, homework</i_keyword>
      <i_keyword>Control group: َAfter the intervention they can attend the sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body image in hysterectomy women. Timepoint: Befor intervation after the intervation. Method of measurement: Multidimensional Body-Self Relation Questionnaire.</prim_outcome>
      <prim_outcome>Quality of sex life in hysterectomy women. Timepoint: Before intervention. Method of measurement: Sexual Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Body image in hysterectomy women. Timepoint: after intervention. Method of measurement: Multidimensional Body-Self Relation Questionnaire.</prim_outcome>
      <prim_outcome>Quality of sex life in hysterectomy women. Timepoint: after intervention. Method of measurement: Sexual Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Quality of sex life in hysterectomy women. Timepoint: one month after intervention. Method of measurement: Sexual Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Body image in women undergone hysterectomy. Timepoint: one month after intervention. Method of measurement: Multidimensional Body-Self Relation 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>deputy of research Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-17</approval_date>
        <contact_name>Ethic committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>kerman-first of Haft Bagh Alavi-Pardis of Kerman University  of Medical Sciences Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
