<?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>IRCT20230610058439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-28</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of progressive muscle relaxation on sexual dysfunction in women with multiple sclerosis in Rafsanjan, 2023</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of progressive muscle relaxation on sexual dysfunction in women with multiple sclerosis in Rafsanjan, 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Sampling is first purposeful and selected based on the criteria for entering the study, then based on the score obtained from the FSFI questionnaire, they are divided into two intervention and control groups, and finally they will be allocated to the two groups by a simple random method. The intervention group will receive progressive muscle relaxation training and no intervention will be performed on the control group, Randomization description: First, the sampling will be purposeful and based on the study entry criteria, for this purpose, the eligible samples will be selected and divided into two groups based on the average score obtained from the FSFI questionnaire. Then, the allocation of samples in two intervention and control groups will be done by simple random drawing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual dysfunction in women with multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Jacobson method of progressive muscle relaxation will be practiced every day for 20 minutes up to 6 weeks at home, at night before going to sleep. The subjects will be asked to wear comfortable clothes. Take out the watch, jewelry, etc. and lie down in a quiet and alone environment without noise or disturbing factors or sit on a chair with complete comfort and then do the sixteen muscle groups, starting from the hands, forearms, and arms. , shoulders, forehead, eyes and nose bridge, cheeks and jaw, mouth, neck, chest, waist or back, stomach, hips, thighs, legs, soleus muscle and finally the whole body, along with the tail Contract for 5 seconds (so that the client notices the contraction and stiffness of the muscle) and then expand and relax the muscles during exhalation for 10 seconds. Intervention 2: Control group: no intervention will be done in the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Tayebeh Negahban Bonabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Blvd., Nurse St., School of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>azarang98@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tayebeh Negahban Bonabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Blvd., Nurse St., School of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>azarang98@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20-45
Obtaining a score less than 28 from the FSFI questionnaire
More than six months have passed since the diagnosis of the disease
Married and having intermittent sex with her husband' and not intending to divorce
Ability to perform daily personal tasks without assistance from others
Extended Disability Status Scale (EDSS) score less than equal to 4.5
Absence of pregnancy
No menopause
Not using sleeping pills, alcohol, drugs and drugs affecting sexual function
Not using common complementary treatments such as yoga, Pilates, meditation at the same time
Not using any kind of sexual drugs
Not having other chronic and acute physical and mental diseases according to the medical record
The husband's absence of known sexual disorders
Not being in the acute stage of the disease
Not having cognitive disorders</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to cooperation
Having lethargy and weakness or reduced level of consciousness
being admitted to the hospital</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Jacobson method of progressive muscle relaxation will be practiced every day for 20 minutes up to 6 weeks at home, at night before going to sleep. The subjects will be asked to wear comfortable clothes. Take out the watch, jewelry, etc. and lie down in a quiet and alone environment without noise or disturbing factors or sit on a chair with complete comfort and then do the sixteen muscle groups, starting from the hands, forearms, and arms. , shoulders, forehead, eyes and nose bridge, cheeks and jaw, mouth, neck, chest, waist or back, stomach, hips, thighs, legs, soleus muscle and finally the whole body, along with the tail Contract for 5 seconds (so that the client notices the contraction and stiffness of the muscle) and then expand and relax the muscles during exhalation for 10 seconds.</i_keyword>
      <i_keyword>Control group: no intervention will be done in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual performance score in the 19-question questionnaire of intimacy and sexual activity in multiple sclerosis (MSISQ19). Timepoint: The measurement of the sexual function score will be before the intervention and 6 weeks after the intervention of muscle relaxation. Method of measurement: The sexual performance score is measured using a 19-question questionnaire of multiple Sclerosis Intimacy and Sexuality.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-14</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Rafsanjan - Imam Ali Boulevard - Central Organization Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
