<?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>IRCT20230524058276N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of the intervention based on the quantitative model of psychological correlates of sexual desire/arousal disorder and activation-behavioral therapy on sexual self-concept, menopausal attitude, sexual dysfunctional beliefs, relationship satisfaction and relational intimacy of postmenopausal women.</public_title>
      <acronym></acronym>
      <scientific_title>Develop a quantitative psychological correlates of sexual arousal / arousal disorders correlations and compare the effectiveness of intervention based on it with behavioral activation therapy on sexual self-concept, menopausal attitude, sexual dysfunction, relationship satisfaction and communication intimacy of postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74027</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The purpose of random allocation is that the clinician cannot predict the treatment of the disease. Random allocation of the type of treatment or random allocation is the heart of the clinical trial study. The samples will be determined by random block method and using random number table, Random Allocation Software. Blocking and allocation sequence will be done for concealment by a person not involved in the research (Allocation Concealment). Blocking: This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization. At certain points, the number of participants in each group is equal. For this method, the size of each block must be determined first (for example, a block of four), then write the list of blocks and assign numbers to them (AABB(1)-ABAB(2)-ABBA(3)-BBAA(4)-BABA) (5) - BAAB (6)), then choosing random numbers between 1 and 6 (for example 1, 4, 5 and ...) and finally specifying the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-) They will be placed in three groups including two intervention groups and one control group, Blinding description: The participants, or in other words, the people who are invited to participate in the study and are classified into intervention groups after obtaining informed consent, may not know the main purpose of the study, these people only know that in a study They participate, which will lead to the improvement of their psychological problems, and they are only unaware of the assignment of groups. Statistical analysts do not know the content of therapy sessions, but they know the assumptions, goals and questions of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual desire/arousal disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Behavioral activation therapy is also treated during 8 sessions of 90 minutes based on the training package of Dimidjin et al. (2008). It is taught simply. The second session of behavioral activation is taught by focusing on the interaction between the person and the environment based on the principles of silence, shaping, elimination and mental review, distance distraction, procedural skills and observational thinking. Providing homework, review and feedback. The third session of healing processes is taught with four topics of advice in the general context of the disease, choosing the appropriate treatment method for the individual's condition, motivational topics and the interaction of the individual with other people and the use of their experience, providing homework, review and feedback. The fourth session is review of the form. The use of verbal positive reinforcement is taught through the expression of positive and hopeful sentences, the presentation of homework, review and feedback. The fifth session of using metaphor is taught in the course of verbal positive reinforcement, the presentation of homework, review and feedback. The sixth session of cognitive reconstruction, Psychosocial aspects of the problem, coping skills, assertiveness skills and treatment in case of recurrence, referral to a psychologist is taught, assignments are given, feedback is taught. In the seventh session, problem solving skills are taught, which includes defining the problem, identifying the factors preventing problem solving, and the problem solving process. , commiting to implement the solution, planning to implement the best solution and implementing the best solution, providing homework, feedback. The eighth session of summarizing, summarizing, and teaching preventive solutions. Intervention 2: Intervention group: ntervention group: treatment package based on the quantitative model of psychological correlates of sexual desire/arousal disorder (Heidari, Sajjadian and Manshai, 1402). Eight 90-minute intervention sessions​. Intervention 3: Control group: a group that does not undergo any intervention. They only complete the questionnaires before and after the study. If they wish, they can undergo intervention after the end of the study.</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 file of the participants only in general and without mentioning the name and address of the participants (number-gender-age-education). The study protocol can also be published as a table. The statistical analysis map can be published in the form of tables and statistical results obtained. Informed consent can be published in its entirety. Applied research results can be published. Statistical methods and statistical analysis can be published. The obtained data can be published in the form of tables. All the above items can be provided in accordance with the guidelines of the magazines and if there is no harm to the participants.

When:
The access period starts with the opinion and agreement of the relevant journals

To whom:
It will be accessible to all people who have access to reliable sources of publishing articles such as reliable magazines and the results of this research can be used for them.

Conditions:
All cases of using the documents will be possible with the permission of the university of the place of study and professors related to the research and in compliance with the existing rules and regulations.

Where to obtain:
Reputable journals in which articles related to research are published. The e-mails of the advisors and advisors and the student implementing the project and their university website will be made available to the applicants to use the results in compliance with the rules and regulations and maintaining the confidentiality of the participants.

How to obtain:
If the laws related to the research documents are followed, the possible requests will be answered as soon as possible.

Comments:
All of the above can be done within the framework of the rules and regulations of research and publication in the relevant journals and universities. If an item is not within the scope of these rules, it will not be published. The special case to be mentioned is maintaining the confidentiality of the participants' information and not harming them.
​</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Heidary Shadehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.</address>
        <city>Shahinshar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8347113574</zip>
        <telephone>+98 31 4529 4738</telephone>
        <email>sm85.heidary@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Heidary Shadehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd.</address>
        <city>Shahinshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8347113574</zip>
        <telephone>+98 31 4529 4738</telephone>
        <email>sm85.heidary@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Menopausal women whose menopause has been 6 months old
Being over 50 years old
Having a sexual desire/arousal disorder
Not taking drugs and drug interventions
Not receiving treatment interventions at the same time</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having at least 2 absent sessions in the intervention process
Having other sexual dysfunctions other than sexual desire/arousal
Having early menopause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypoactive sexual desire disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Behavioral activation therapy is also treated during 8 sessions of 90 minutes based on the training package of Dimidjin et al. (2008). It is taught simply. The second session of behavioral activation is taught by focusing on the interaction between the person and the environment based on the principles of silence, shaping, elimination and mental review, distance distraction, procedural skills and observational thinking. Providing homework, review and feedback. The third session of healing processes is taught with four topics of advice in the general context of the disease, choosing the appropriate treatment method for the individual's condition, motivational topics and the interaction of the individual with other people and the use of their experience, providing homework, review and feedback. The fourth session is review of the form. The use of verbal positive reinforcement is taught through the expression of positive and hopeful sentences, the presentation of homework, review and feedback. The fifth session of using metaphor is taught in the course of verbal positive reinforcement, the presentation of homework, review and feedback. The sixth session of cognitive reconstruction, Psychosocial aspects of the problem, coping skills, assertiveness skills and treatment in case of recurrence, referral to a psychologist is taught, assignments are given, feedback is taught. In the seventh session, problem solving skills are taught, which includes defining the problem, identifying the factors preventing problem solving, and the problem solving process. , commiting to implement the solution, planning to implement the best solution and implementing the best solution, providing homework, feedback. The eighth session of summarizing, summarizing, and teaching preventive solutions</i_keyword>
      <i_keyword>Intervention group: ntervention group: treatment package based on the quantitative model of psychological correlates of sexual desire/arousal disorder (Heidari, Sajjadian and Manshai, 1402). Eight 90-minute intervention sessions​</i_keyword>
      <i_keyword>Control group: a group that does not undergo any intervention. They only complete the questionnaires before and after the study. If they wish, they can undergo intervention after the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual self-concept is a part of individuality and self-sexuality; In other words, a person's understanding of his sexual desires and tendencies is the same as his sexual self-concept. Timepoint: At the beginning of the study, after the intervention and 45 days after the intervention. Method of measurement: Sexual self-concept in this research is the score that the subjects get from Ansel's (2013) sexual self-concept questionnaire. This questionnaire contains 78 questions and 18 subscales. The range of scores in each subscale is 5 to 25. Scores higher than the average in each subscale indicate that the individual has more of that characteristic (tendency). If the scores of the questionnaire are between 1 and 20, the variable rate in this society is weak. If the scores of the questionnaire are between 21 and 60, the variable amount is at an average level. If the scores are above 60, the level of the variable is high.</prim_outcome>
      <prim_outcome>Attitude is a set of beliefs, emotions and behavioral intentions towards an object, person or event. In other words, it is a relatively stable desire for a person, something or an event that manifests itself in feelings and behavior. Timepoint: At the beginning of the study, after the intervention and 45 days after the intervention. Method of measurement: Menopause attitude in this research is the score that the subjects got from Neugarten's attitude towards menopause questionnaire (1963). This questionnaire contains 35 items, in this questionnaire, each item is given a score with a 5-point range from 0 to 4, and the total score is added after counting all the items, and higher scores are given to positive attitudes and grades. lower was attributed to negative attitude. The cut-off point is considered to be 40, and a score of 40 and above is considered a positive attitude, and a score below that is considered a negative attitude.</prim_outcome>
      <prim_outcome>Sexual dysfunctional belief is a set of attitudes and stereotypes about sexual performance that endangers the sexual relationship of couples.​. Timepoint: At the beginning of the study, after the intervention and 45 days after the intervention. Method of measurement: In this research, the meaning of sexual dysfunctional belief is the scores that will be obtained in response to the questionnaire of Neuber, Pinto and Govia (2003). In this questionnaire, scoring is done in a direct way and a higher score indicates a greater impact of sexual dysfunctional beliefs on sexual performance. It is women and men.</prim_outcome>
      <prim_outcome>Relationship satisfaction is defined as the level of satisfaction that a person has in his closest adult relationship with another person in different dimensions. This level includes communication and honesty, intimacy and closeness, resolving conflicts and arguments, satisfaction with his role in the relationship and Satisfaction with another's role in the relationship and overall satisfaction with the relationship. Timepoint: At the beginning of the study, after the intervention and 45 days after the intervention. Method of measurement: The meaning of relationship satisfaction is the score that each subject obtained in the 7-item relationship satisfaction scale of Burns and Cyrus (1988). The scores of the groups of this questionnaire range from 0-10 indicating a very dissatisfied person, 20-11 indicating a dissatisfied person, 21-25 indicating a relatively dissatisfied person, and 30-26 indicating a somewhat dissatisfied person, 31-35 indicating a somewhat satisfied person. 36-40 indicates relatively satisfied and 41-42 indicates a very satisfied person.​.</prim_outcome>
      <prim_outcome>Ommunication intimacy is the need to communicate and share all emotions, including positive emotions (joy, ecstasy, and excitement) and negative emotions (sadness, failure, fear, guilt, loneliness, and depression) with the spouse. Timepoint: At the beginning of the study, after the intervention and 45 days after the intervention. Method of measurement: Communication intimacy means the score that each subject obtained in Shafer and Olson's (1981) 36-question communication intimacy scale. The overall score of this questionnaire is between 1 and 120. The amount of difference between two scores of received intimacy and expected intimacy indicates the level of satisfaction of the person with intimacy.</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>(دانشگاه ازاد اسلامی واحد اصفهان (خوراسگان</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-13</approval_date>
        <contact_name>Isfahan Islamic Azad University (Khorasgan).</contact_name>
        <contact_address>Unit 18- Ramin Complex- 1st sub-section- 8 East sub-section- Taleghani Blvd. Shahinshahr Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
