<?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>IRCT20100524004015N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-23</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of yoga and pelvic floor muscle exercises on sexual performance index and sexual self-esteem</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Yoga and pelvic floor muscle exercises on the sexual function index and sexual self-esteem of reproductive age women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to randomly assign the samples to two intervention and control groups, tables of 6 blocks (table of random numbers) will be used. In this way, a number is included for the names of the registered people, then using 6 block tables and random allocation software, these numbers are randomly placed in one of the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sexual self-esteem. Condition 2: sexual performance index.</hc_freetext>
      <i_freetext>Intervention 1: In addition to performing pelvic floor muscle exercises at home, the intervention group will participate in a 12-session exercise program designed by a yoga instructor and researcher in one of the clubs affiliated to Shahrekord University of Medical Sciences. The yoga exercise program is carried out as 2 sessions per week for 6 weeks, with each session lasting from 45 minutes in the first 4 weeks to 75 minutes in the final weeks, with varying degrees of intensity. The training program in each session includes three parts: warm-up movements (Pawan Moket), Salam Barkhorshid cycle, main cycle movements (Asana) and cooling and relaxation (Shavasana). Exercises start from a low level and progress gradually. If necessary, the selected exercises are adjusted for the subjects who are not able to maintain their posture while doing it, and in this way, the principle of paying attention to the individual differences of the subjects is respected. In order to overload principle, the repetition of movements in each session increases compared to the previous session. At the beginning of each session, for 15-20 minutes, we will have warm-up exercises for joints and muscles (Pawan Moket). These warm-up exercises include 3 general categories of movements: joint warm-up, core muscle warm-up and movements related to unblocking energy pathways. Then 10 minutes of the exercise are dedicated to the sun salutation cycle. The movements related to this cycle include stretching, strength, balance, contraction and inversion movements. After performing the sun salutation cycle, the movements of the main cycle (asana) designed by the yoga instructor are performed in a period of 20 minutes. Finally, 10 to 15 minutes are considered at the end of the workout for cooling down and relaxation movements (Shavasana). Intervention 2: Control group: Control group only do pelvic floor muscle exercises at home. It is worth noting that the subjects of both the intervention and control groups are fully trained on how to perform this pelvic floor muscle exercise at home during a joint briefing before random assignment.</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 study data including demographic information, sexual self-esteem status and sexual performance index before and after the intervention can be published.

When:
Only after publishing the article extracted from this data can be published.

To whom:
Researchers related to the research field

Conditions:
In order to generalize the results of the research, after the publication of the article, if the researcher has a convincing reason to use the data and undertakes to refer to the information of this research.

Where to obtain:
Send your request to the responsible person's email.

How to obtain:
Email request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zeinab Tavakol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatiye</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3334 1412</telephone>
        <email>zeinab.tavakol@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zinab Tavakol</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahmatiye</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3334 1214</telephone>
        <email>zeinab.tavakol@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20-54
First marriage
Literacy for reading and writing
Absence of alcohol and drug addiction
Living with a spouse
Living in Shahrekord city
Absence of any known underlying physical and mental illness
No history of pregnancy and breastfeeding
No self-reported sexual abuse
Not taking drugs that affect sexual function (diuretics, sympatholytics, alpha blockers, beta blockers, antipsychotics, antidepressants, histamine receptor blockers, gonadotropin-releasing hormone agonists, OCPs)
Absence of known sexual function disorders in couples
No history of surgery in genital and pelvic areas in couples</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>54 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In addition to performing pelvic floor muscle exercises at home, the intervention group will participate in a 12-session exercise program designed by a yoga instructor and researcher in one of the clubs affiliated to Shahrekord University of Medical Sciences. The yoga exercise program is carried out as 2 sessions per week for 6 weeks, with each session lasting from 45 minutes in the first 4 weeks to 75 minutes in the final weeks, with varying degrees of intensity. The training program in each session includes three parts: warm-up movements (Pawan Moket), Salam Barkhorshid cycle, main cycle movements (Asana) and cooling and relaxation (Shavasana). Exercises start from a low level and progress gradually. If necessary, the selected exercises are adjusted for the subjects who are not able to maintain their posture while doing it, and in this way, the principle of paying attention to the individual differences of the subjects is respected. In order to overload principle, the repetition of movements in each session increases compared to the previous session. At the beginning of each session, for 15-20 minutes, we will have warm-up exercises for joints and muscles (Pawan Moket). These warm-up exercises include 3 general categories of movements: joint warm-up, core muscle warm-up and movements related to unblocking energy pathways. Then 10 minutes of the exercise are dedicated to the sun salutation cycle. The movements related to this cycle include stretching, strength, balance, contraction and inversion movements. After performing the sun salutation cycle, the movements of the main cycle (asana) designed by the yoga instructor are performed in a period of 20 minutes. Finally, 10 to 15 minutes are considered at the end of the workout for cooling down and relaxation movements (Shavasana).</i_keyword>
      <i_keyword>Control group: Control group only do pelvic floor muscle exercises at home. It is worth noting that the subjects of both the intervention and control groups are fully trained on how to perform this pelvic floor muscle exercise at home during a joint briefing before random assignment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual performance index: in classified sexual activity, if the score obtained from the questionnaire is equal to 36, sexual performance is good, 29 to 32 is average, and less than 23 is poor. Timepoint: Before the intervention, immediately after the end of the intervention, one month after the end of the intervention. Method of measurement: Sexual function index questionnaire (FSFI).</prim_outcome>
      <prim_outcome>Sexual self-esteem: by adding the scores of 5 areas of sexual self-esteem, the total score of the scale is obtained, and a higher score indicates a higher sexual self-esteem. Cronbach's alpha coefficient was reported as 0.92 for the whole scale, 0.84 for skill and experience, 0.88 for attractiveness, 0.80 for control, 0.80 for moral judgment, and 0.80 for conformity. Timepoint: Before the intervention, immediately after the end of the intervention, one month after the end of the intervention. Method of measurement: Sexual satisfaction questionnaire (SSEI-W-SF).</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-15</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Rahmatiye Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
