<?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>IRCT20230901059315N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of energy therapy on pain and vital signs of patients after open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Reiki practice on sternotomy incision pain and hemodynamic criteria after CABG</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: randomization method and its explanation: simple randomization; Study participants are randomly divided into control and intervention groups.
Randomization Unit: Parallel
Randomization layers: None
Allocation concealment method: simple randomization
How to make a random sequence: simple random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sternotomy incision pain and hemodynamic criteria after CABG.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention method: researcher for the intervention group; The researcher first intends to perform Reiki by putting his hands on the heart for the intention and the sentences he says to himself during the intention have the meaning that we want divine energies to flow, so (for example) the researcher during the intention these sentences with He himself says: [I ask the divine energies to flow in me in the most powerful, most blessed and beautiful way and make me a channel of energy, I thank God for helping me in this process and I guides, I am grateful to the Reiki masters and guides, I am grateful to myself, and because we do Reiki for another person, we also thank that person]; Also, to make sure that Reiki flows in our palm; We press the intersection of the index finger and the thumb, then for 15-30 minutes standard Reiki exercises on 27 points with respect to Reiki level 1 (doing exercises for yourself and others at a close distance) by placing the hands at a distance (angle placement) The hands are not important and can be in any shape) on the selected areas in order: The middle of the forehead (it is called the third eye chakra, which is the place where a person communicates with himself), temples, ears, crown chakra, throat chakra, thymus, lungs, heart chakra from the front and back, hands, solar plexus chakra (points around the navel), then the points of the thighs, separately or together, knees, legs, ankles and the last part of the soles of the feet, the area of ​​the kidneys in any position that is more comfortable for the patient and on each point for 1-2 minutes He repeats affirmative sentences with himself, the content of which is gratitude to the cells (I thank you cells for serving my body for years, You are fresh, energetic and healthy and any other positive words) and finally on mid-sternal incision according to the Reiki protocol for 2 minutes in addition to the selected points every 12 hours, at least 4 hours after receiving Apotel, days 4 to 6 after the operation in the open heart surgery department of the hospital Imam Reza will be performed for 3 days along with pain measurement and previous hemodynamic criteria, at least 10 to 15 minutes and finally one hour after Reiki. Intervention 2: Control group: Control group: The control group does not receive any intervention and the usual pain control methods in the hospital (Apotel 150 mg) are performed for them. The intervention will be evaluated.</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:
The pain level of the patient before and after the intervention, respectively: the first 12 hours, the second 12 hours, the third 12 hours
The amount of changes in the hemodynamic parameters of the patients before and after the intervention, respectively: the first 12 hours, the second 12 hours, the third 12 hours.
Individual information (individual data) of patients is not displayed.

When:
Maximum 2 months

To whom:
Researchers working in academic and practical institutions

Conditions:
Under the conditions specified by the researcher and with his permission, they can use the documents

Where to obtain:
They can interfere with the performer: Sara Ahmadi
Contact number: 09368300995

How to obtain:
After coordination with the researcher and if the researcher gives permission to use the study documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazila Zarghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3189 2105</telephone>
        <email>ZarghiN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazila Zarghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3189 2105</telephone>
        <email>ZarghiN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A patient who is a candidate for heart surgery who needs coronary artery bypass surgery. Age 18 to 70 years, Persian speaking ability and ability to read and write, awareness of time and place, not having concomitant diseases that affect the perception of pain (such as diabetes).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to cooperate in all stages of the study or in case of unexpected complications.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Intervention method: researcher for the intervention group; The researcher first intends to perform Reiki by putting his hands on the heart for the intention and the sentences he says to himself during the intention have the meaning that we want divine energies to flow, so (for example) the researcher during the intention these sentences with He himself says: [I ask the divine energies to flow in me in the most powerful, most blessed and beautiful way and make me a channel of energy, I thank God for helping me in this process and I guides, I am grateful to the Reiki masters and guides, I am grateful to myself, and because we do Reiki for another person, we also thank that person]; Also, to make sure that Reiki flows in our palm; We press the intersection of the index finger and the thumb, then for 15-30 minutes standard Reiki exercises on 27 points with respect to Reiki level 1 (doing exercises for yourself and others at a close distance) by placing the hands at a distance (angle placement) The hands are not important and can be in any shape) on the selected areas in order: The middle of the forehead (it is called the third eye chakra, which is the place where a person communicates with himself), temples, ears, crown chakra, throat chakra, thymus, lungs, heart chakra from the front and back, hands, solar plexus chakra (points around the navel), then the points of the thighs, separately or together, knees, legs, ankles and the last part of the soles of the feet, the area of ​​the kidneys in any position that is more comfortable for the patient and on each point for 1-2 minutes He repeats affirmative sentences with himself, the content of which is gratitude to the cells (I thank you cells for serving my body for years, You are fresh, energetic and healthy and any other positive words) and finally on mid-sternal incision according to the Reiki protocol for 2 minutes in addition to the selected points every 12 hours, at least 4 hours after receiving Apotel, days 4 to 6 after the operation in the open heart surgery department of the hospital Imam Reza will be performed for 3 days along with pain measurement and previous hemodynamic criteria, at least 10 to 15 minutes and finally one hour after Reiki.</i_keyword>
      <i_keyword>Control group: Control group: The control group does not receive any intervention and the usual pain control methods in the hospital (Apotel 150 mg) are performed for them. The intervention will be evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain and hemodynamic parameters. Timepoint: Pain measurement and hemodynamic criteria are done at the beginning of the study (before the intervention) and every 12 hours for 3 days after the intervention. Method of measurement: Visual Analogue Scale and  Monitoring.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-25</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>No. 30, Aboreihan Bironi  Ave., Shahid Aldaghi Blvd., Sabzevar Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
