<?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>IRCT20151004024342N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-07</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on low back pain and fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the severity of low back pain and fatigue after coronary atrial angioplasty by femoral</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A randomized controlled clinical trial is available. Thus, 25 people in the acupressure group, 25 people in the false intervention group and 25 people in the control group will be selected for research. 75 envelopes are provided and number one to 75 is written on each envelope. And is placed in the envelope of group A, group B and group C. Eligible patients will receive the envelopes in order, and if it was group A, it will be in the intervention group, if it was group B, it will be in the second intervention group, and if it was group C, it will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: In the acupressure intervention group in four areas: point 36 of the stomach (ST36), submandibular midline (GV26), point 3 of the small intestine (SI3), point 60 of the bladder (BL60) each for two minutes for a total of fourteen minutes at intervals of two, Four, six and eight hours after the angioplasty is performed, then the low back pain and fatigue questionnaire is completed between two, four, six and eight hours before and after the acupressure intervention by the patient. Intervention 2: In the control group, the false intervention was performed as a gentle massage in four points: ST36, GV26, SI3, BL60, for two minutes each for a total of fourteen minutes at intervals of two, four, six and eight hours after angioplasty. The interval of two, four, six and eight hours before and after the gentle massage is completed by the patient.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vida Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Sari, School of Nursing and Midwifery, Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815696869</zip>
        <telephone>+98 11 3379 5555</telephone>
        <email>fateme.r.nurse@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vida Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Sari, School of Nursing and Midwifery, Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815696869</zip>
        <telephone>+98 11 3379 5555</telephone>
        <email>vidashafipour@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining informed consent from the patient
Age over 18 years
Maximum time of femoral angioplasty in lip coat 1 hour
Stabilization of vital signs including blood pressure, temperature, pulse, respiration
No communication problems such as hearing or speech impairment
Taking oral sedatives according to the routine of the relevant unit before angioplasty
No scars, lesions, scratches or abnormalities on the skin of acupressure points</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. hemodynamic symptoms (blood pressure, pulse, respiration)
2. Arrhythmia and complications after angioplasty (bleeding, hematoma)
3. Critical condition of the patient and return of the patient to the lip coat
4. Use of narcotic drugs and other analgesics
5. Existence of motor and neuromuscular disorders such as Parkinson's, multiple sclerosis, congenital lumbar vertebral disorders
Lumbar-related diseases include lumbar disc herniation with evidence of referred pain in the legs, spinal canal stenosis, lumbar surgery, severe low back pain due to discopathy in the last 1 month, see a specialist at least once due to back pain or back pain Intense in the last 1 month</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the acupressure intervention group in four areas: point 36 of the stomach (ST36), submandibular midline (GV26), point 3 of the small intestine (SI3), point 60 of the bladder (BL60) each for two minutes for a total of fourteen minutes at intervals of two, Four, six and eight hours after the angioplasty is performed, then the low back pain and fatigue questionnaire is completed between two, four, six and eight hours before and after the acupressure intervention by the patient.</i_keyword>
      <i_keyword>In the control group, the false intervention was performed as a gentle massage in four points: ST36, GV26, SI3, BL60, for two minutes each for a total of fourteen minutes at intervals of two, four, six and eight hours after angioplasty. The interval of two, four, six and eight hours before and after the gentle massage is completed by the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue after angioplasty. Timepoint: At 2, 4, 6 and 8 hours after angioplasty. Method of measurement: Visual Analogue fatigue Scale(vafs).</prim_outcome>
      <prim_outcome>Low back pain after angioplasty. Timepoint: At 2, 4, 6 and 8 hours after angioplasty. Method of measurement: Visual Analogue Scale(vas).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-25</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Iran, Mazandaran, Sari, Moallem Square, University Building No. 2, Vice Chancellor for Research, Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
