<?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>IRCT20210808052114N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-14</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of jacobson relaxation onfamily Caregivers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of jacobson relaxation on fatigue and happiness among family Caregivers of hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58048</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research units will be selected by available sampling method and then randomly divided into two groups: experimental (even days) and control (odd days) by coin toss.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gentrification by Jacobson Method.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: In this method, the muscles contract for approximately 5 seconds and then slowly release (expand) for 20 to 30 seconds. First, he sits in a relaxing chair and thinks of a relaxing subject, preferablThe first step takes a slow and deep breath and then slowly exits up to 5 numbers to repeat 5 times.The second and third stages, first the right wrist contracts and then expands, then the forearm and arms contract into figurative position and then expand. All the steps in the left hand are repeated as well.The fourth step, first we raise the eyebrows and then let go, then press the eyes tightly, then slowly release, with the mouth closed, create a smile line and then go to y a view he likes and has never been to before. We release slowly, at the end we bring the chin forward and then let go.Step five, we put the abdomen forward with the waist and then we release the abdomen and then let go of the abdomen and then let go. We will.And then we put the abdomen in and then we release it, the sixth and seventh stages, first we hang the right leg, pull the fingers forward and then let go, we give up the para wrist, then we release the para, from the fingertip to the shin, and then we hold it to 90 degrees with the body, and then we release it.  Para from fingertip to shin to 90 degrees with the body and then release and at the end of the foot to the abdomen and then release all the steps in the left leg is repeated.1 The following points should be observed:1. Breathing during contraction and expansion of muscles is done normally and the breath is not kept at all.2. During contraction and expansion of muscles, it is tried to feel the difference between these two good operations. Of course, if this feeling doesn't touch the person at first, after a while, it will feel the difference.3. During muscle expansion, focus your senses on the muscles and the muscles are gradually released.4 . Practice is performed once for 45 minutes.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vice Chancellor for Research and Technology, AJA University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>steerit kaj</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>16151139</zip>
        <telephone>+98 21 7750 0929</telephone>
        <email>Afsaneh.ravash@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Ravash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.kaj sterit.,daneshkadeh parastari artesh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>16151139</zip>
        <telephone>+98 21 3324 9537</telephone>
        <email>Afsaneh.ravash@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Age range of 18 to 60 years- taking on the role of primary caregiver - being a family member - performing at least six months of patient care - receiving three dialysis times a week by the patient under care - having read and write literacy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No history of psychological disorders (self-reported) no drug abuse and sedatives, no history of education and implementation of Jacobson method, no history of crisis during the last 4 weeks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In this method, the muscles contract for approximately 5 seconds and then slowly release (expand) for 20 to 30 seconds. First, he sits in a relaxing chair and thinks of a relaxing subject, preferablThe first step takes a slow and deep breath and then slowly exits up to 5 numbers to repeat 5 times.The second and third stages, first the right wrist contracts and then expands, then the forearm and arms contract into figurative position and then expand. All the steps in the left hand are repeated as well.The fourth step, first we raise the eyebrows and then let go, then press the eyes tightly, then slowly release, with the mouth closed, create a smile line and then go to y a view he likes and has never been to before. We release slowly, at the end we bring the chin forward and then let go.Step five, we put the abdomen forward with the waist and then we release the abdomen and then let go of the abdomen and then let go. We will.And then we put the abdomen in and then we release it, the sixth and seventh stages, first we hang the right leg, pull the fingers forward and then let go, we give up the para wrist, then we release the para, from the fingertip to the shin, and then we hold it to 90 degrees with the body, and then we release it.  Para from fingertip to shin to 90 degrees with the body and then release and at the end of the foot to the abdomen and then release all the steps in the left leg is repeated.1 The following points should be observed:1. Breathing during contraction and expansion of muscles is done normally and the breath is not kept at all.2. During contraction and expansion of muscles, it is tried to feel the difference between these two good operations. Of course, if this feeling doesn't touch the person at first, after a while, it will feel the difference.3. During muscle expansion, focus your senses on the muscles and the muscles are gradually released.4 . Practice is performed once for 45 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue and happiness. Timepoint: Before the intervention and 2 and 4 weeks after jacobson relaxation. Method of measurement: Fatigue and Happiness 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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-15</approval_date>
        <contact_name>Ethics Committee of Army Medical Sciences University</contact_name>
        <contact_address>Pine Street tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
