<?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>IRCT20230307057652N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-24</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of self-management program on Quality of life and Self efficacy in women with Polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Self-management program on Quality of life and Self efficacy in women with Polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69094</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women are selected by available sampling method and using random number sequence and through online software (www.Random.org/sequences), patients are divided into two intervention groups (providing self-management program 5A) and control group. (presentation of educational booklets) (32 people each) are allocated. Again, the research units in the intervention group are divided into two subgroups by a simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group receives the self-management program based on the 5A model in the virtual network. In the Assess stage, after effective communication, height, weight and body mass index are measured. In the Advise stage, Information is given about the abnormal cases obtained from the first stage and the disadvantages of low self-efficacy, low quality of life, disadvantages of increasing body mass index, stress management, adherence to treatment, adoption of a healthy lifestyle, appropriate physical activity and proper diet  will be explained. In the Agree stage, suitable and agreed behavioral goals will be adjusted. In the Assist stage, 5 training sessions of 45 to 60 minutes (1 session per week) are offered. In training sessions, about polycystic ovary syndrome, importance of healthy fertility, definition of stress, stress coping techniques, importance of self-care, importance of healthy lifestyle, how to calculate daily calories, how to calculate body mass index and its interpretation, how to measure circumference The waist and its interpretation, the role of nutrition in the treatment and control of disease, the pyramid of food groups, how to read food labels, correct diet recommendations, recommendations for weight loss and appropriate physical activity are given. Also, the checklist related to physical activity or the form to complete the meal plan or the daily checklist of practicing the relaxation technique is recorded by the patient on a daily basis. In the Arrange stage, In the first two weeks, by sending a daily SMS, after two weeks, the practical plan will be reminded twice a week, and then once a week for a month, follow-up will be done to remind the implementation of the practical plan. Intervention 2: Control group: Self-management routine training is done in the control group. Also, after completing the study, an educational booklet related to polycystic ovary syndrome will be 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:
All personal data of study participants can be shared after un identifying

When:
After results publication

To whom:
The data will be available to researchers working in academic and scientific institutions, and people working in industry can also apply to receive it.

Conditions:
Scientific usage

Where to obtain:
sh_mojahed@yahoo.com

How to obtain:
One week after receiving the requested email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahnaz Mojahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>sh_mojahed@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Mojahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>sh_mojahed@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of polycystic ovary syndrome based on the confirmation of a specialist doctor or recorded in the medical record
At least one year has passed since the diagnosis of the disease
Being literate in reading and writing
Having an Android or iOS smart phone
Ability to participate in training sessions
Women who live with their husbands and are the only wives of their husbands
Being Iranian
Age (15-49)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in consulting studies
Existence of various types of severe mental disorders (psychosis, schizophrenia, etc.) under medical treatment based on medical record information or statements
Smoking, drugs and alcohol
Existence of stressful events during the last 6 months such as immigration, death of relatives, divorce
Treated with assisted reproductive methods
Restrictions on physical activity
Having diseases that require following a special diet (such as phenylketonuria)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group receives the self-management program based on the 5A model in the virtual network. In the Assess stage, after effective communication, height, weight and body mass index are measured. In the Advise stage, Information is given about the abnormal cases obtained from the first stage and the disadvantages of low self-efficacy, low quality of life, disadvantages of increasing body mass index, stress management, adherence to treatment, adoption of a healthy lifestyle, appropriate physical activity and proper diet  will be explained. In the Agree stage, suitable and agreed behavioral goals will be adjusted. In the Assist stage, 5 training sessions of 45 to 60 minutes (1 session per week) are offered. In training sessions, about polycystic ovary syndrome, importance of healthy fertility, definition of stress, stress coping techniques, importance of self-care, importance of healthy lifestyle, how to calculate daily calories, how to calculate body mass index and its interpretation, how to measure circumference The waist and its interpretation, the role of nutrition in the treatment and control of disease, the pyramid of food groups, how to read food labels, correct diet recommendations, recommendations for weight loss and appropriate physical activity are given. Also, the checklist related to physical activity or the form to complete the meal plan or the daily checklist of practicing the relaxation technique is recorded by the patient on a daily basis. In the Arrange stage, In the first two weeks, by sending a daily SMS, after two weeks, the practical plan will be reminded twice a week, and then once a week for a month, follow-up will be done to remind the implementation of the practical plan.</i_keyword>
      <i_keyword>Control group: Self-management routine training is done in the control group. Also, after completing the study, an educational booklet related to polycystic ovary syndrome will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the average quality of life scores in women with polycystic ovary syndrome. Timepoint: At the baseline and completion of the intervention at week 12. Method of measurement: Quality of life questionnaire for women with polycystic ovary syndrome(Cornin and et al.).</prim_outcome>
      <prim_outcome>Measuring mean self-efficacy scores in women with polycystic ovary syndrome. Timepoint: At the baseline and completion of the intervention at week 12. Method of measurement: General Self-Efficacy Scale(Scherer).</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-01</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
