<?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>IRCT20191130045558N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of Hypnotherapy, Cognitive-Behavioral therapy (CBT) and Cognitive-Behavioral Hypnotherapy (CBH) treatment on Resilience, Sleep quality, Sexual satisfaction and Physical symptoms in women with Fibromyalgia syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Hypnotherapy, Cognitive-Behavioral therapy (CBT) and Cognitive-Behavioral Hypnotherapy (CBH) treatment on Resilience, Sleep quality, Sexual satisfaction and Physical symptoms in women with Fibromyalgia syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49793</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypnotherapy, Cognitive Behavioral Therapy ,Cognitive Behavioral Hypnotherapy, Resiliency, Sleep Quality, Sexual ‎Satisfaction,Physical Symptoms, Fibromyalgial syndrome.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually. Intervention 2: Second Intervention group: Cognitive_Behavioral Therapy is performed in 8 sessions per week, one session of 60 minutes  which will be hold individually. Intervention 3: Third Intervention group: Cognitive-Behavioral Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually. Intervention 4: Control group: Without intervention.</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:
the whole research

When:
3month after published

To whom:
psychologists
psychiatrists
physitions

Conditions:
for scientific researches

Where to obtain:
mkolbadi483@gmail.com

How to obtain:
researcher's corresponding e.mail:
Mkolbadi483@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Kolbadinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 16 street, golshar blvd</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916818933</zip>
        <telephone>+98 17 3252 3853</telephone>
        <email>Mkolbadi483@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Pourasghar Arabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 16 street, golshar blvd</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916818933</zip>
        <telephone>+98 17 3252 3853</telephone>
        <email>Me_Pourasghar@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not receiving coherent psychological therapies.
Married women
Age 20 to 60
Having a minimum level of diploma education
Patient consent to participate in the study and sign a written consent
No Psychotic disorder
No substance abuse
No serious medical illnesses; Includes severe liver and kidney failure
Not having serious thoughts of self harm and debtors
Not having Antisocial personality disorder</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Serious thoughts of harming yourself and others
Having severe liver and kidney failure
Having Antisocial Personality disorder
Substanse abuse
Having Psychotic Disorders
Single women
Less than 20 and above 60 years old
Under diploma degree</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fibromyalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually.</i_keyword>
      <i_keyword>Second Intervention group: Cognitive_Behavioral Therapy is performed in 8 sessions per week, one session of 60 minutes  which will be hold individually.</i_keyword>
      <i_keyword>Third Intervention group: Cognitive-Behavioral Hypnotherapy is performed in 8 sessions per week, one session of 60 minutes which will be hold individually.</i_keyword>
      <i_keyword>Control group: Without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical Symptoms. Timepoint: 20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy. Method of measurement: Paul and Enrit Physical Symptoms Questionnaire.</prim_outcome>
      <prim_outcome>Resiliency. Timepoint: 20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy. Method of measurement: Conner and Davidson Resiliency Questionnaire.</prim_outcome>
      <prim_outcome>Sleep Quality. Timepoint: 20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy. Method of measurement: Peterzburg Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Sexual Satisfaction. Timepoint: 20 days before therapy, after 2nd, 4th, 6th, 7th and 8th therapy sessions, follow up 1 and 3 months after the end of therapy. Method of measurement: Roshan Sexual  Satisfaction 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>Azad uiversity of Gorgan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-22</approval_date>
        <contact_name>Ethics Committe of Aliabad Katool Azad University</contact_name>
        <contact_address>Univesity Blvd, Azad University Ali Abad Katool Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
