<?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>IRCT20110912007529N24</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-02</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Investigating the effect of acupressure  on improving pain and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on pain and anxiety in elderly female candidates for extracorporeal shock wave lithotripsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62648</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples were selected using a convenience sample method and were randomly allocated to two groups as intervention and control using the block randomization method with a block size of 4 and with a 2:2 assignment ratio. Randomization tool: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: In patients' control, similar places are performed in the intervention group with the same duration (without any pressure). The post-intervention information is collected by unbiased collaborations of the uninformed patients. Data analysis will be done by people who do not have the code information.Therefore patients and sampler and the statistical analyzer will be blind to patients ‘allocation of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Calculus of kidney.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, acupressure by a trained person's thumb on 4 points on both sides of the body, including He7, Lu7, K1, LI4 (Hugo point, located on the back of the hand between bones 1 and 2 and on the radial side of the second metacarpal. The Lu7 point is located in the radial part of the forearm, above the styloid appendage of the ulnar bone, at a distance of 3.5 cm or 1.5 cun above the transverse crease of the wrist. The seventh heart point is located directly on the transverse crease of the wrist with the Carmen flexor tendon of the ulnar, and the K1 point is located at the junction of the anterior third, and posterior two-thirds of the sole (between the second and third toes) to reduce pain and Anxiety is used, where each point is pressed for 2 minutes and a total of 20 minutes and twice. Intervention 2: Control group: In this group, similar places are performed in the intervention group with the same duration (without any pressure).</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:
some of the statistical data is available after being unidentifiable

When:
The access period is up to after the publication of the results.

To whom:
Data is available to academic researchers

Conditions:
Use of information for academic research projects is allowed.

Where to obtain:
Nahid Rejeh 
reje@shahed.ac.ir

How to obtain:
Requests for specific information should be sent by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran Qom Express way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 3550</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran Qom Express way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 3550</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60 years of age or older,
ability to understand Persian,
having adequate hearing and vision,
no chronic neuropathic diseases,
no cognitive impairment,
The first experience of referring to a lithotripsy treatment program,
no amputation of the limbs,
no pain or sore in hands (at the place of acupressure),
no dependence or addiction to any drugs,
do not take sedatives and anti-anxiety drugs daily for more than a month,
do not take painkillers for 24 hours before the intervention,
do not take drugs that reduce or increase cortisol (for two weeks Before wave lithotripsy ).</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>unwillingness to continue to participate in the study,
patients who during acupressure in He7, Lu7, K1, LI4 does not feel hot, heavy, swollen or numb at this point</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney</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: In this group, acupressure by a trained person's thumb on 4 points on both sides of the body, including He7, Lu7, K1, LI4 (Hugo point, located on the back of the hand between bones 1 and 2 and on the radial side of the second metacarpal. The Lu7 point is located in the radial part of the forearm, above the styloid appendage of the ulnar bone, at a distance of 3.5 cm or 1.5 cun above the transverse crease of the wrist. The seventh heart point is located directly on the transverse crease of the wrist with the Carmen flexor tendon of the ulnar, and the K1 point is located at the junction of the anterior third, and posterior two-thirds of the sole (between the second and third toes) to reduce pain and Anxiety is used, where each point is pressed for 2 minutes and a total of 20 minutes and twice.</i_keyword>
      <i_keyword>Control group: In this group, similar places are performed in the intervention group with the same duration (without any pressure).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: The intensity of pain will be evaluated before and after extracorporeal shock wave lithotripsy. Method of measurement: Visual Pain Scale.</prim_outcome>
      <prim_outcome>Quality of pain. Timepoint: The intensity of pain will be evaluated before and after extracorporeal shock wave lithotripsy. Method of measurement: MacGill questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intensity of anxiety. Timepoint: The intensity of anxiety will be evaluated before intervention and after the intervention. Method of measurement: Visual Analogue Scale for Anxiety.</sec_outcome>
      <sec_outcome>Quality of anxiety. Timepoint: The intensity of anxiety will be evaluated before intervention and after the intervention. Method of measurement: Spielberger.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-01</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed university, Opposite Holy Shrine of Imam Khomeini, Tehran-Qom Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
