<?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>IRCT20150424021917N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-03</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise and acupressure on hot flash</public_title>
      <acronym></acronym>
      <scientific_title>The effect of exercise and acupressure on flushing in women with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using RAS software, through blocks with six and nine blocks will randomly (There are groups, in each group in which 6 or 9 people come in each category)assigned to Three groups of exercise, acupressure and control . To hide the allocation, the type of intervention will be written on paper and placed inside the packets matched and numbered sequentially(Allocation Concealment).</study_design>
      <phase>N/A</phase>
      <hc_freetext>flushing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: acupressure.For the acupressure group, the pressure on the HE7 and HE GU points on the hands and Sp6 point will be applied to the feet. Pressure on these points will be performed three days a week for 15 minutes, with 3 minutes of pressure for each point and 2 minutes for the spot, under the supervision of an acupuncturist (collaborator) at their office for 8 weeks. Intervention 2: Intervention group: Sports activities.For a sports activity group, an aerobic exercise program is considered in an exercise room under the supervision of a sports coach, a weekly 3 days for 60 minutes in 8 weeks. During this period, the researcher will supervise the exercise program on a regular basis. Intervention 3: Control group: Receives routine training,In accordance with,tutorials provided in the program of the ministry of Saba(Iranian women's health).</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:
Only part of the information, such as information on the main outcome or the like, can be shared

When:
Start publishing period 6 months after printing results

To whom:
Only available to scholars working in academic institutions

Conditions:
All university students and scholars. By email

Where to obtain:
Sevil Hakimi
hakimis@tbzmed.ac.ir

How to obtain:
The applicant sends an application via e-mail. After receiving the email, the results will be sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sevil Hakimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Boulevard, Tabriz Town</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>hakimis@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sevil hakimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery Faculty, Shariati Avenue. Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3475 3907</telephone>
        <email>hakimis@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-45 years old
Women with hot flash at least twice a day for  6 weeks
Completion of radiotherapy and chemotherapy at least 8 weeks before, the next referral of chemotherapy at least 10 weeks later
Women with 5 or more score in pittsburgh sleep disturbances questionnaire
Women with ductal or lobular insitu breast cancer or 1,2,3 stage without metastastasis
Without experience hot flash before breast cancer
without any sensory motor disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with BMI higher than 30 kg/m2
Use of hot flash reducing and sedative drugs
Women with hyperthyroidism
Doing any kind of exercise regularly and professionally
Apply acupuncture within 2 weeks before starting the study
Cardiovascular disease
Restrictions on physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R23.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Flushing</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: acupressure.For the acupressure group, the pressure on the HE7 and HE GU points on the hands and Sp6 point will be applied to the feet. Pressure on these points will be performed three days a week for 15 minutes, with 3 minutes of pressure for each point and 2 minutes for the spot, under the supervision of an acupuncturist (collaborator) at their office for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Sports activities.For a sports activity group, an aerobic exercise program is considered in an exercise room under the supervision of a sports coach, a weekly 3 days for 60 minutes in 8 weeks. During this period, the researcher will supervise the exercise program on a regular basis.</i_keyword>
      <i_keyword>Control group: Receives routine training,In accordance with,tutorials provided in the program of the ministry of Saba(Iranian women's health)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hot flash. Timepoint: Before Intervention,Week 4 Intervention and Week 8 Intervention. Method of measurement: Hot flash scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep disorders. Timepoint: Before intervention, week 4 intervention and week 8 intervention. Method of measurement: Pittsburgh Sleep Quality Index.</sec_outcome>
      <sec_outcome>Satisfaction with the treatment. Timepoint: after intervention. Method of measurement: Survey.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-16</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
