<?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>IRCT20250730066695N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-14</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of pressure point massage on physiological indicators of patients after coronary angiography</public_title>
      <acronym>PPMCA</acronym>
      <scientific_title>Comparison of the effectiveness of PC6 and ST36 acupressure on cardiac physiological indices in patients after coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to balance the number of samples in each group and prevent bias in allocation, a randomization method with permutation blocks with a block size of 10 will be used. In this method, all possible combinations of five groups including: Intervention group 1 with PC6 pressure point stimulation, Intervention group 2 with ST36 pressure point stimulation, Sham group 1 related to PC6, Sham group 2 related to ST36, and Control group (no intervention) are defined within blocks of 10. Then, the list of combinations is randomly sorted using statistical software, and the final patient allocation table is prepared by an independent statistician, Blinding description: The study is designed as a double-blind study; the interventionist is aware of the group allocation, but the participants, statistical analyst, and care nurses are unaware of the type of intervention received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1 (PC6 point massage): In addition to standard postoperative care, patients in the intervention group will undergo acupressure at the PC6 point. Massage site: The inner surface of the forearm, two fingers above the wrist crease, between the palmaris longus and flexor carpi radialis tendons. Intervention 2: Intervention Group 2 (ST36 point massage): In addition to standard care, patients in this group will receive acupressure at the ST-36 point. The massage site is four finger widths below the lower edge of the kneecap and approximately 2.5 cm outward along the tibia. Intervention 3: Sham group 1 (related to PC6 pressure point): In addition to receiving standard care, patients in this group are subjected to mechanical pressure similar in duration, intensity, and method of application to the PC6 intervention group; the difference is that pressure is applied to a non-therapeutic point with no energy meridian path, approximately 1 to 1.5 centimeters away from the actual PC6 point. Intervention 4: Pseudo Group 2 (related to the ST36 pressure point): In this group, in addition to the usual ward care, patients receive pressure similar in duration (5 minutes), intensity (uniform pressure with the thumb), and method of applying pressure, but at a non-therapeutic point with no therapeutic properties, located 1 to 1.5 centimeters from the actual location of ST36. Intervention 5: Control group: Patients in this group will only receive standard intensive care unit 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 En Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>keyhan jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences (UMSHA), Building No. 4, Shariati Crossroad., Hamadan, Iran.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 7250</telephone>
        <email>Keyhanjafari2974@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Arezou Karampourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences (UMSHA), Building No. 4, Shariati Crossroad., Hamadan, Iran.</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>Diagnostic angiography via femoral or radial artery and admission to CCU
Age 18 to 85 years
No skin lesions, ulcers, or active inflammation in the areas of the targeted pressure points (PC6 and ST36)
Stable hemodynamic status based on initial assessment by the attending physician
No use of medications that affect the autonomic nervous system or cardiovascular responses (such as beta-blockers, sedatives, or centrally acting antidepressants)
No history of using acupressure or other similar complementary methods in the past 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of hemodynamic instability or need for emergency measures during the study (including need for vasopressors or cardiopulmonary resuscitation or shock)
The occurrence of any acute complications after angiography (such as severe bleeding, significant arrhythmia, extensive hematoma, or embolism)
Lack of effective cooperation or patient withdrawal from continuing to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B97.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus as the cause of diseases classified elsewhere</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>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1 (PC6 point massage): In addition to standard postoperative care, patients in the intervention group will undergo acupressure at the PC6 point. Massage site: The inner surface of the forearm, two fingers above the wrist crease, between the palmaris longus and flexor carpi radialis tendons.</i_keyword>
      <i_keyword>Intervention Group 2 (ST36 point massage): In addition to standard care, patients in this group will receive acupressure at the ST-36 point. The massage site is four finger widths below the lower edge of the kneecap and approximately 2.5 cm outward along the tibia.</i_keyword>
      <i_keyword>Sham group 1 (related to PC6 pressure point): In addition to receiving standard care, patients in this group are subjected to mechanical pressure similar in duration, intensity, and method of application to the PC6 intervention group; the difference is that pressure is applied to a non-therapeutic point with no energy meridian path, approximately 1 to 1.5 centimeters away from the actual PC6 point.</i_keyword>
      <i_keyword>Pseudo Group 2 (related to the ST36 pressure point): In this group, in addition to the usual ward care, patients receive pressure similar in duration (5 minutes), intensity (uniform pressure with the thumb), and method of applying pressure, but at a non-therapeutic point with no therapeutic properties, located 1 to 1.5 centimeters from the actual location of ST36.</i_keyword>
      <i_keyword>Control group: Patients in this group will only receive standard intensive care unit care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean arterial pressure (MAP). Timepoint: Before intervention (Baseline), immediately after intervention, 10 minutes after intervention, 20 minutes after intervention, 30 minutes after intervention. Method of measurement: Using a digital blood pressure monitor.</prim_outcome>
      <prim_outcome>Heart rate (HR). Timepoint: Before intervention (Baseline), immediately after intervention, 10 minutes after intervention, 20 minutes after intervention, 30 minutes after intervention. Method of measurement: Using a cardiac monitoring device.</prim_outcome>
      <prim_outcome>Peripheral perfusion index (PI). Timepoint: Before intervention (Baseline), immediately after intervention, 10 minutes after intervention, 20 minutes after intervention, 30 minutes after intervention. Method of measurement: Using a digital pulse oximeter.</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>2025-09-06</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>
