<?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>IRCT20190603043803N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-18</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Peer Support Program on the Sexual Quality of Life of Stoma Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Study of the Effect of Peer Support Program on the Sexual Quality of Life of Stoma Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40783</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, selected samples will randomly assign to the control and intervention groups based on the permutation blocks method. The blocks in volume of 4 are product using random numbers by a computer and for allocation in these blocks; two members of the peer and control groups will be placed for each block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Intestinal Ostomy (Ileostomy). Condition 2: Intestinal Ostomy(Colostomy).</hc_freetext>
      <i_freetext>Intervention 1: The intervention of this study is using peer support program, which is organized as 4 group sessions to share common experiences of individuals with each other in order to increase their sexual quality of life.These sessions are weekly and a 90-60 minute session is held every week. It should be noted that in the pretest stage, those who have higher scores from the quality of life questionnaire as well as are interested in leading the group are selected as leaders of the group of peers. Intervention 2: Control group: Individuals of this group, like other eligible study samples, is selected by simple random sampling. Then, they are randomly assigned to the control group using permutation blocks and no intervention is made on sexual quality of life for this group. Then, their score of sexual quality of life is compared with the intervention group(peer group) before, immediately and after 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:
Main data, after being unidentifiable and respecting the principle of privacy  can be shared in the dissertation file and the extant article.

When:
Start access to the thesis file is 6 months after the final defense of the thesis by the student
Start access to the full text of the article to be redistributed is immediately after printing

To whom:
All individuals who are researchers at university institutes and researchers working in other institutions, including the private sector, can take action to receive shared data.

Conditions:
In order to use the results of this study to plan for more comprehensive studies or use the results of this study to design appropriate supportive educational interventions for patients

Where to obtain:
Department of Adult Health Nursing, School of Nursing and Midwifery, Isfahan University of Medical Sciences,Isfahan, Iran. Ladan Naseh 
Tel: 0098 913 285 0361
Email: Naseh@nm.mui.ac.ir

How to obtain:
Within 7 business days after receipt of the written request by email and the full introduction of the applicant, along with the name of the organization or institution in which they are employed and the data is to be used there, the documents are to be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ladan Naseh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid hoseinian Alley., Keshavarzi Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174898631</zip>
        <telephone>+98 31 3777 6981</telephone>
        <email>naseh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ladan Naseh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Hoseinian Alley(No. 17)., Keshavarzi Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174898631</zip>
        <telephone>+98 31 3777 6981</telephone>
        <email>naseh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a permanent Intestinal Stoma (Ileostomy  and Colostomy)
Pass at least 3 months from the surgery
Being married
Having complete alertness and consciousness
Being fluent in persian</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction to participate in the study
Having a history of participation in any related training program or research
Having alcohol or drug addiction or taking medications that affect the sexual function
Having advanced diseases of vital organs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y83.3; Z43</hc_code>
      <hc_code>Y83.3; Z43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Surgical operation with formation of external stoma; Attention to ileostomy</hc_keyword>
      <hc_keyword>Surgical operation with formation of external stoma; Attention to colostomy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention of this study is using peer support program, which is organized as 4 group sessions to share common experiences of individuals with each other in order to increase their sexual quality of life.These sessions are weekly and a 90-60 minute session is held every week. It should be noted that in the pretest stage, those who have higher scores from the quality of life questionnaire as well as are interested in leading the group are selected as leaders of the group of peers.</i_keyword>
      <i_keyword>Control group: Individuals of this group, like other eligible study samples, is selected by simple random sampling. Then, they are randomly assigned to the control group using permutation blocks and no intervention is made on sexual quality of life for this group. Then, their score of sexual quality of life is compared with the intervention group(peer group) before, immediately and after the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>One primary outcome variable is  men's Sexual Quality of Life score in the  men's Sexual Quality of Life questionnaire. Timepoint: Before the intervention(pretest), immediately and one month after the intervention(post tests). Method of measurement: The Men's Sexual Quality of Life Questionnaire is used. This questionnaire has 11 questions and it is scored based on a six-point Likert scale ranging from 1 to 6(quite disagree to quite agree). The range of questionnaire's score  is from 11 to 66   and the higher score obtained from the questionnaire indicates the higher sexual quality of life.</prim_outcome>
      <prim_outcome>Another primary outcome variable is  women's  Sexual Quality of Life score in the women's Sexual Quality of Life questionnaire. Timepoint: Before the intervention(pretest), immediately and one month after the intervention(post tests). Method of measurement: The Women's Sexual Quality of Life questionnaire is used. This questionnaire has 18 questions and is scored based on a six-point Likert scale ranging from 1 to 6 (strongly disagree to strongly agree). The range of questionnaire's score  is  from 18 to 108 and the higher the score obtained from the questionnaire, the higher the quality of sex life.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-09</approval_date>
        <contact_name>Ethics in research Committee of Isfahan University of Medical Sciences.</contact_name>
        <contact_address>Hezar Jareeb Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
