<?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>IRCT20230221057475N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-02</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of hand and foot reflexology on chest pain and anxiety in patients after primary coronary angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of hand reflexology with foot reflexology on chest pain and anxiety in patients after primary coronary angioplasty.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68731</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocating the samples to the study groups randomly, the random permutation block design with six blocks will be used; Then the website https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence. Sealed envelopes will be used for concealment. Thus, based on the sequence of randomly determined blocks, cards with the letters A (for the hand reflexology group), B (for the foot reflexology group) and C (for the control group) will be placed inside the envelope, which shows the allocation sequence. became. Then an envelope will be opened for each participant in the study, and based on the card inside the envelope, the participant will be assigned to the control or test group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute myocardial infraction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The patient lies on the bed in a quiet environment. We place a pillow under the patient's feet, after removing the ornaments and washing the hands, the masseur begins to perform the intervention. Foot reflexology is performed on the patient's left foot for 15 minutes. Massage oil, which has no therapeutic value, is used to perform reflexology. Pressure will be applied for 30 seconds with the tip of the thumb to the center of the sole of the foot at the point of the solar plexus at the junction of the ball of the foot and the arch of the foot. Reflexology will be done with a circular movement with both thumbs from the center of the foot to the outside of the foot. Finally, the heart area (the center of the ball of the foot) will be massaged with the thumb in one movement. Intervention 2: Intervention group: The patient lies on the bed in a quiet environment. After removing the jewelry and washing the hands, the masseuse starts to perform the intervention. Hand reflexology is performed on the patient's left hand for 15 minutes. To perform reflexology, massage oil is used, which has no therapeutic value. To perform hand reflexology, the researcher will start massaging the hand from the sides of the hand and move towards the palm, the back of the hand, and finally the fingers. This process will be repeated eight to ten times until the hand is completely relaxed and ready for reflexology. The reflex point for the cardiovascular system includes: the heart point located on the palm, under the soft area at the bottom of the ring and little fingers, the massager will press the reflexology point with his thumb. Reflexology points will be massaged 14 times in a row clockwise and with circular movements. Intervention 3: Control group: The patient lies on the bed in a quiet environment, we place a pillow under the patient's feet, after removing the ornaments and washing the hands, the masseuse begins to perform the intervention. Foot reflexology is performed on the patient's right foot for 15 minutes. Massage oil, which has no therapeutic value, is used to perform reflexology. Pressure will be applied for 30 seconds with the tip of the thumb to the center of the sole of the foot at the point of the solar plexus at the junction of the ball of the foot and the arch of the foot. Reflexology will be done with a circular movement with both thumbs from the center of the foot to the outside of the foot. Finally, the heart area (the center of the ball of the foot) will be massaged with the thumb in one movement.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Asali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifer Zanjan, Mahdavi Blvd., Karmandan Town,Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>sasali075@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Asali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Mahdavi Blvd, Karmandan Town</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>sasali075@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who have been subjected to angioplasty for the first time
Trans femoral angiography
Having a pulse on the leg and a normal posterior tibial pulse
Age between 30 and 70 years
Having healthy hands and feet
Full consciousness</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of diabetes
Having an addiction
Having mental problems
People who have received thrombolytic drugs (retplase) after MI and then underwent angiography.
5) Any physiological or hemodynamic instability during and after angiography, such as cardiac dysrhythmia.
Active bleeding at the catheter site
People who have already been subjected to angiography
DVT history
The presence of wounds, scars on the leg
Use of anti-anxiety drugs
Peripheral neuropathy
Tickling feeling in hands and feet
The presence of coagulation problems in the patient
hypertension</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</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:The patient lies on the bed in a quiet environment. We place a pillow under the patient's feet, after removing the ornaments and washing the hands, the masseur begins to perform the intervention. Foot reflexology is performed on the patient's left foot for 15 minutes. Massage oil, which has no therapeutic value, is used to perform reflexology. Pressure will be applied for 30 seconds with the tip of the thumb to the center of the sole of the foot at the point of the solar plexus at the junction of the ball of the foot and the arch of the foot. Reflexology will be done with a circular movement with both thumbs from the center of the foot to the outside of the foot. Finally, the heart area (the center of the ball of the foot) will be massaged with the thumb in one movement.</i_keyword>
      <i_keyword>Intervention group: The patient lies on the bed in a quiet environment. After removing the jewelry and washing the hands, the masseuse starts to perform the intervention. Hand reflexology is performed on the patient's left hand for 15 minutes. To perform reflexology, massage oil is used, which has no therapeutic value. To perform hand reflexology, the researcher will start massaging the hand from the sides of the hand and move towards the palm, the back of the hand, and finally the fingers. This process will be repeated eight to ten times until the hand is completely relaxed and ready for reflexology. The reflex point for the cardiovascular system includes: the heart point located on the palm, under the soft area at the bottom of the ring and little fingers, the massager will press the reflexology point with his thumb. Reflexology points will be massaged 14 times in a row clockwise and with circular movements.</i_keyword>
      <i_keyword>Control group: The patient lies on the bed in a quiet environment, we place a pillow under the patient's feet, after removing the ornaments and washing the hands, the masseuse begins to perform the intervention. Foot reflexology is performed on the patient's right foot for 15 minutes. Massage oil, which has no therapeutic value, is used to perform reflexology. Pressure will be applied for 30 seconds with the tip of the thumb to the center of the sole of the foot at the point of the solar plexus at the junction of the ball of the foot and the arch of the foot. Reflexology will be done with a circular movement with both thumbs from the center of the foot to the outside of the foot. Finally, the heart area (the center of the ball of the foot) will be massaged with the thumb in one movement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chest pain. Timepoint: Before the start of the intervention, 15 minutes, 3 hours and 6 hours after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the start of the intervention, 15 minutes, 3 hours and 6 hours after the end of the intervention. Method of measurement: Visual Analogue Scale.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-14</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>No.1154, West second Eshragh Ave., Shahryar Town Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
