<?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>IRCT20230507058109N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-15</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of psycho-sexual counseling based on the Schover model on the Sexual self-concept and sexual distress of hysterectomy women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of psycho-sexual counseling based on the Schover model on the Sexual self-concept and sexual distress of hysterectomy women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70193</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the random allocation method (envelope), the final participants are divided into two test groups (50 people) and control (50 people). For random allocation, 100 envelopes are placed inside the box, 50 of these envelopes contain the number 1 and the other 50 contain the number 2. The participants choose one of the envelopes in the pack, if they choose the envelope containing the number 1. Enter the intervention group and if the envelope contains the number 2, enter the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hysterectomy women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: hysterectomized women, psycho-sexual counseling based on the Skover model during 4 weekly sessions of 90-120 minutes, the content of these sessions will include: evaluation of activity, performance and sexual relations, evaluation of concomitant diseases, mental , disabilities and examining the skills to deal with these challenges and treatments received.. Also, hysterectomy description and psychological and sexual consequences, examination of common sexual problems after hysterectomy (decrease in the frequency of sexual activity, decrease in vaginal moisture, decrease in sexual satisfaction, decrease Sexual desire and stimulation, inability to reach orgasm, pain during intercourse, change in sensation (numbness, pain or itching), change in reaching orgasm after hysterectomy, change in body function or mental image of the body following removal of the uterus, complications side related to disease or treatment), assessment of common psychological factors after hysterectomy (distorted body image, anxiety, depression, anger, impaired sense of femininity following loss of uterus and fertility, fear of injury and loss Other organs or exacerbation of the current situation, lack of coping skills, history of sexual, emotional or psychological abuse in the past, wrong cultural-social beliefs and superstitions of pre-existing sexual patterns), familiarity with sexual function and internal and external male organs and Woman, getting to know the pattern of sexual response, describing the physiological changes of men and women during sexual activity, definitions of sexual desire, arousal, slippage, climactic climax, answering possible questions of clients, evaluating communication factors after hysterectomy (change in personal or professional roles E. Difficulties in communication, decrease in the quality of communication with a life partner, difficulty in maintaining intimacy, lack of a life partner, social determinants in relation to self-care (recommendation from others), lack of suitable conditions for establishing a private environment based on life conditions. - Clarifying and clarifying expectations, correcting misconceptions and superstitions about sex, techniques for writing down needs and expectations from sex, solutions to deal with psychological-sexual changes after surgery - providing necessary information and training about sensory focus techniques, Advice on stretching exercises and pelvic floor exercises to improve sexual function, suitable positions to reduce pain during intercourse, ways to reduce vaginal irritation and irritation, available treatments to reduce vaginal dryness and urinary incontinence, nutritional recommendations, sleep hygiene education and performing stretching and sports exercises and recommending daily walks, sleep and bedroom hygiene, explaining the components of Sternberg's love triangle - explaining the role of commitment, love and intimacy in an effective relationship with a spouse, familiarizing and emphasizing the importance of flirting and behaviors after marriage Intercourse, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance of flirting and making love, examining the determining factors in the quality of relationships, teaching creation skills and maintaining intimacy (counseling to improve the way of talking, listening empathetically and sharing feelings in creating intimacy), finding the roots of situational/pervasive sexual desire reduction and providing a solution.. It should be noted that the content of counseling and providing information during group counseling will be advanced based on the needs and demands of the group members. Intervention 2: Control group: Hysterectomy women, these people are not given any counseling, but after the end of the intervention, an educational package is provided to them.</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:
Only part of the data is shared

When:
6 months after the results are published

To whom:
researchers

Conditions:
For research work

Where to obtain:
Email

How to obtain:
Email me

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Maloum</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zaker St</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6257757168</zip>
        <telephone>+98 939 800 7443</telephone>
        <email>zeinab.maloom75@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Maloum</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zaker</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6257757168</zip>
        <telephone>+98 61 3552 1720</telephone>
        <email>zeinab.maloom75@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Be of reproductive age (18-49 years old)
6-3 months have passed since hysterectomy
Subtotal and total hysterectomy without  oophorectomy
Have not gone through menopause before hysterectomy
Be married and living His partnership with his wife should continue (not about to divorce)
Not having chronic diseases such as mental disorders, physical disabilities, AIDS and hepatitis according to the patients themselves
Hysterectomy due to benign indications
Having at least one child
Do not have vaginitis
Do not have a history of vaginismus
No addiction to psychoactive drugs or narcotics in couples</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 months</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- Absence of consent
Participant does not want to continue the study
Absence of even one of the counseling sessions
Participant attends educational or sexual counseling sessions outside the study environment</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: hysterectomized women, psycho-sexual counseling based on the Skover model during 4 weekly sessions of 90-120 minutes, the content of these sessions will include: evaluation of activity, performance and sexual relations, evaluation of concomitant diseases, mental , disabilities and examining the skills to deal with these challenges and treatments received.. Also, hysterectomy description and psychological and sexual consequences, examination of common sexual problems after hysterectomy (decrease in the frequency of sexual activity, decrease in vaginal moisture, decrease in sexual satisfaction, decrease Sexual desire and stimulation, inability to reach orgasm, pain during intercourse, change in sensation (numbness, pain or itching), change in reaching orgasm after hysterectomy, change in body function or mental image of the body following removal of the uterus, complications side related to disease or treatment), assessment of common psychological factors after hysterectomy (distorted body image, anxiety, depression, anger, impaired sense of femininity following loss of uterus and fertility, fear of injury and loss Other organs or exacerbation of the current situation, lack of coping skills, history of sexual, emotional or psychological abuse in the past, wrong cultural-social beliefs and superstitions of pre-existing sexual patterns), familiarity with sexual function and internal and external male organs and Woman, getting to know the pattern of sexual response, describing the physiological changes of men and women during sexual activity, definitions of sexual desire, arousal, slippage, climactic climax, answering possible questions of clients, evaluating communication factors after hysterectomy (change in personal or professional roles E. Difficulties in communication, decrease in the quality of communication with a life partner, difficulty in maintaining intimacy, lack of a life partner, social determinants in relation to self-care (recommendation from others), lack of suitable conditions for establishing a private environment based on life conditions. - Clarifying and clarifying expectations, correcting misconceptions and superstitions about sex, techniques for writing down needs and expectations from sex, solutions to deal with psychological-sexual changes after surgery - providing necessary information and training about sensory focus techniques, Advice on stretching exercises and pelvic floor exercises to improve sexual function, suitable positions to reduce pain during intercourse, ways to reduce vaginal irritation and irritation, available treatments to reduce vaginal dryness and urinary incontinence, nutritional recommendations, sleep hygiene education and performing stretching and sports exercises and recommending daily walks, sleep and bedroom hygiene, explaining the components of Sternberg's love triangle - explaining the role of commitment, love and intimacy in an effective relationship with a spouse, familiarizing and emphasizing the importance of flirting and behaviors after marriage Intercourse, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance of flirting and making love, examining the determining factors in the quality of relationships, teaching creation skills and maintaining intimacy (counseling to improve the way of talking, listening empathetically and sharing feelings in creating intimacy), finding the roots of situational/pervasive sexual desire reduction and providing a solution.. It should be noted that the content of counseling and providing information during group counseling will be advanced based on the needs and demands of the group members.</i_keyword>
      <i_keyword>Control group: Hysterectomy women, these people are not given any counseling, but after the end of the intervention, an educational package is provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual self-concept. Timepoint: Before and one month after the intervention. Method of measurement: Sexual self-concept 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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-19</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Zakir St Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
