<?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>IRCT20220111053686N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-29</date_registration>
      <primary_sponsor>Shahid Rajaei Cardiovascular Research and Training Center</primary_sponsor>
      <public_title>The effect of acupressure on pain and sleep quality in cancer patients after surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on pain and sleep quality of cancer patients undergoing surgery admitted to the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61312</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block randomization method will be used to allocate samples (block size: 4). Thus, the letter A is considered for the intervention group and the letter B for the control group. Then all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, are written on the 6 cards in the following order:AABB،ABBA،ABAB،BAAB،BABA،BBAA.Then, from numbers 1 to 6, a card will be randomly selected by patient number one.For example, number 2 was chosen, which means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group, and this process continued until the sample size reached the quorum, Blinding description: This is a single blind study in which patients are unaware that they are receiving  acupressure or gentle surface pressure. The  intervention group will receive acupressure and the control group will receive a gentle surface pressure at the same points.</study_design>
      <phase>N/A</phase>
      <hc_freetext>other acute post procedural pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 40 patients with cancer admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Visual Analog Scale), on the second and third day after surgery will be exposed to  acupressure massage, on the LI4 points (between the base of thumb and index finger)  and the SP6 points (the shin bone on the inside of the ankle)  for periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening. Intervention 2: Control group: 40 cancer patients admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Vision Analog Scale), on the second and third days after surgery will be exposed to superficial touch on LI4 points and SP6 during periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening.</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:
Information on age, sex, type of cancer, marital status, occupation, education, place of residence, history of smoking, drug and alcohol use, and receiving painkillers on the second and third days after surgery can be shared.

When:
6 months after the publication of the results

To whom:
All academics and researchers and professionals in the field of treatment

Conditions:
.In order to conduct more and more comprehensive research and complete the research process for its clinical application..

Where to obtain:
mahya jafari
jafari.mh1990@gmail.com

How to obtain:
After sending an email to the researcher, the file and documents will be provided to the people in a short time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No. 12, Jahangiri Alley, Mahmoudi St, South Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1643673174</zip>
        <telephone>+98 21 7726 3242</telephone>
        <email>m-jafari@alumnus.tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No. 12, Jahangiri Alley, Mahmoudi St, South Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1643673174</zip>
        <telephone>+98 21 7726 3242</telephone>
        <email>m-jafari@alumnus.tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be at least 18 years old
Diagnosis of any type of cancer
Having chronic pain in connection with cancer surgery and its expression by the patient
Having full consciousness
Listening and speaking ability
Minimum ability to read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>cognitive and behavioral disorders
mental disorder to the extent of daily use of psychiatric drugs
history of limb amputation, surgery or wound in pressure points</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute post procedural pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 40 patients with cancer admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Visual Analog Scale), on the second and third day after surgery will be exposed to  acupressure massage, on the LI4 points (between the base of thumb and index finger)  and the SP6 points (the shin bone on the inside of the ankle)  for periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening.</i_keyword>
      <i_keyword>Control group: 40 cancer patients admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Vision Analog Scale), on the second and third days after surgery will be exposed to superficial touch on LI4 points and SP6 during periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with a pain score of 7 or more. Timepoint: Twice a day on the second and third days after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before the intervention and in the morning after the last intervention. Method of measurement: The Richards-Campbell Sleep 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>Shahid Rajaei Cardiovascular Research and Training Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-12</approval_date>
        <contact_name>Medical Ethics Committee of Shahid Rajaei Cardiovascular Center</contact_name>
        <contact_address>2nd floor, research building, Shahid Rajaei Research &amp; Training Hospital, Next to Mellat Park, Vali-Asr Ave, Tehran, IRAN tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
