<?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>IRCT20250927067381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-15</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Hugo point massage on body pain and fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Hugo point massage on body pain and fatigue in patients with brucellosis admitted to the infectious disease ward of Sina Hospital, Hamadan.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>174</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86455</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will first be selected via convenience sampling and randomly assigned in a crossover design to one of three groups: Group A (pressure applied at the Hugo point), Group B (pressure applied at a sham point), and Group C (control). Randomization will be carried out using permuted blocks of three; specifically, the sequences BCA, ABC, BAC, CAB, CBA, BAC, and ACB will be written on slips of paper and placed into sealed envelopes. Upon obtaining informed consent, each patient will select one envelope and be allocated to the corresponding group according to the letter sequence, Blinding description: Randomization was carried out using permuted blocks of three. The block sequences BCA, ABC, BAC, CAB, CBA, BAC, and ACB were written on paper and placed in sealed envelopes. After obtaining informed consent, each participant selected one envelope; assignment to the corresponding group followed the order indicated by the letters. Participants remained unaware of their group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>brucellosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: In this group, in addition to routine post-treatment care, the Hegu point is first identified. A gentle pressure massage is then applied for 30 seconds, with the pressure gradually increased until the participant experiences tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. The thumb is maintained on the point for 1 minute; subsequently, the pressure is progressively released over 30 seconds to fully release the point. Each intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum of 20 minutes, comprising three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached). Intervention 2: Intervention Group 2: In this group, in addition to routine post-treatment care, pressure massage is applied to a point located outside the Hegu point as follows. First, gentle pressure is exerted on the non-Hegu point for 30 seconds, with the force gradually increased until the participant experiences pronounced tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. Next, the thumb remains in place for 1 minute; thereafter, the pressure is progressively released over 30 seconds to fully release the point. The entire intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum total of 20 minutes, consisting of three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached). Intervention 3: Control Group: In this group, no acupressure therapy will be administered, and participants will receive only routine post-treatment care.</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 The release schedule has not yet been determined.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Rabiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514894294</zip>
        <telephone>+98 81 3830 2243</telephone>
        <email>r.rabiei@edu.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezo Karamporian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 7250</telephone>
        <email>a.karampourian@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To be under a doctor's supervision for all patients
To be literate in reading and writing in order to complete the questionnaire
To be aged 18 and above</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>To have a history of mental disorders based on the patient's medical records
To participate in pain reduction programs of other studies
To take painkillers other than the ward's routine medication
To have a skin lesion at the site of acupressure application
To be unwilling to continue cooperation
To develop a serious physical problem
To receive less than four sessions of training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A23</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Brucellosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: In this group, in addition to routine post-treatment care, the Hegu point is first identified. A gentle pressure massage is then applied for 30 seconds, with the pressure gradually increased until the participant experiences tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. The thumb is maintained on the point for 1 minute; subsequently, the pressure is progressively released over 30 seconds to fully release the point. Each intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum of 20 minutes, comprising three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached).</i_keyword>
      <i_keyword>Intervention Group 2: In this group, in addition to routine post-treatment care, pressure massage is applied to a point located outside the Hegu point as follows. First, gentle pressure is exerted on the non-Hegu point for 30 seconds, with the force gradually increased until the participant experiences pronounced tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. Next, the thumb remains in place for 1 minute; thereafter, the pressure is progressively released over 30 seconds to fully release the point. The entire intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum total of 20 minutes, consisting of three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached).</i_keyword>
      <i_keyword>Control Group: In this group, no acupressure therapy will be administered, and participants will receive only routine post-treatment care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score on the NRS questionnaire (Numeric Rating Scale for pain assessment). Timepoint: To complete the Numeric Rating Scale (NRS) before and after the intervention. Method of measurement: Numeric Rating Scale (NRS).</prim_outcome>
      <prim_outcome>Score on the Multidimensional Fatigue Inventory (MFI) questionnaire. Timepoint: To complete the Multidimensional Fatigue Inventory (MFI) before and after the intervention. Method of measurement: Multidimensional Fatigue Inventory (MFI).</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-20</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Office of Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences (UMSHA), Building No. 4, Shariati Crossroad., Hamadan, Iran. Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
