<?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>IRCT20161126031117N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-15</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of online narrative therapy on the genital self-image of infertile women. A randomized controlled clinical trial study</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of online narrative therapy and routine care on the genital self-image of infertile women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocking method will be used for random assignment of samples to two groups of 32. For this purpose, 16 blocks of four will be considered. The six possible blocks are TTCC TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in the range 0 to 6) and according to the production values of one of the blocks (for a production number between 0 to 1 CTTC block, for a production number between 1 to 2 blocks CTCT and so on) will be selected and samples will be assigned.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertile women with a negative genital self image.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 5 90-minute sessions (1 session per week) as a group, in 4 groups of 7 people and a group of 4 people, narrative therapy counseling package (compilation of therapy package based on the theory of narrative therapy and concepts and principles The theory has been narrative therapy) will be implemented online and using the WhatsApp platform, by a master student in midwifery counseling, which is supervised by a research team including: a reproductive health specialist and a PhD student in clinical psychology. It should be noted that participants prepare their narration in writing (file typed in word or handwritten photo) and send it to the researcher in privatebmessage on the WhatsApp platform. The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions. Intervention 2: Control group: The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.</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:
Research-related information is shared with the aim of keeping individuals' names and identities confidential and adhering to the 31 Code of Ethics.

When:
2022

To whom:
All researchers and research enthusiasts

Conditions:
For review and supplementary research and For use by therapists of infertile women

Where to obtain:
If the article is published according to the address of the magazine, you can refer to that magazine. Also, for additional information, you can access the responsible author by e-mail khanisog343@gmail.com and the e-mail of the midwifery student by e-mail fateme.shahriari.midwife@gmail.com.

How to obtain:
She /He must first send an email to the author of the article and submit her request, and if the author and the research team deem it appropriate, the documents and files will be provided in a short time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Soghara Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.</address>
        <city>SARI</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817857344</zip>
        <telephone>+98 11 3336 8915</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soghara Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Mazandarani St. - Vesal Alley - Nasibeh School of Nursing and Midwifery</address>
        <city>SARI</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817857344</zip>
        <telephone>+98 11 3336 8915</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being Iranian
Having literacy and literacy
Speaking Persian
Having an age between 18-49 years
Having Primary infertility for more than one year confirmed by a gynecologist and infertility specialist
Having a smart phone and internet
getting a registered marriage
Having a written consent to participate in the research
Being generally healthy based on the Goldberg General Health Questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Couples' addiction to drugs and alcohol
The occurrence of a stressful accident in the past six months
Use of drugs affecting sexual function
Having obvious physical disabilities and Mentally affecting sexual function
History of pelvic surgery or radiation to the genitals
Having an adopted child</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>MB27.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disturbance of body image</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: In the intervention group, 5 90-minute sessions (1 session per week) as a group, in 4 groups of 7 people and a group of 4 people, narrative therapy counseling package (compilation of therapy package based on the theory of narrative therapy and concepts and principles The theory has been narrative therapy) will be implemented online and using the WhatsApp platform, by a master student in midwifery counseling, which is supervised by a research team including: a reproductive health specialist and a PhD student in clinical psychology. It should be noted that participants prepare their narration in writing (file typed in word or handwritten photo) and send it to the researcher in privatebmessage on the WhatsApp platform. The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.</i_keyword>
      <i_keyword>Control group: The control group will also receive routine care, and after the intervention, a narrative therapy educational pamphlet will be provided to the control group, and a session will be held to answer any questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Genital self-image. Timepoint: Before, immediately and 45 days after the intervention. Method of measurement: Genital self-image Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction. Timepoint: Before, immediately and 45 days after the intervention. Method of measurement: Hudson Sexual Satisfaction Questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-02</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moallem Square, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences SARI Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
