<?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>IRCT20240602061989N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-21</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Reflexology and Acupressure on Fatigue and its Consequences in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Reflexology and Acupressure on Fatigue and its Consequences in Hemodialysis Patients in the Healthcare Centers of Hormozgan University of Medical Sciences, Bandar Abbas, 1402 – 1403</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77272</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, simple randomization will be done using random sequence generation software. The randomization unit is individual, and sequentially numbered, sealed, opaque envelopes will be used for concealment, Blinding description: One person as an outcome evaluator, without knowing the allocation of patients in groups, will perform all the evaluations in the waiting room before and after hemodialysis and immediately leave the hemodialysis department after doing it. He will not face patients during hemodialysis during intervention or non-intervention. In the continuation of blinding, he codes the data of the evaluation sheet and uploads it to the statistical software. The data analyst will also analyze the data without knowing the allocation of patients in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatigue, anxiety and depression in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Reflexology group: in this group, in addition to the usual care in the hemodialysis department, foot reflexology massage is performed. After one hour of the start of hemodialysis, the researcher holds the heel of the patient's left foot with his left hand at the room temperature and bends and straightens it from the wrist by pressing on the sole of the foot, then with the thumb of the right hand (thumb pulp) on The solar plexus point (right below the sole of the foot at the junction of the anterior 1 / 3 and the posterior 2 / 3 of the sole in the midline) will apply direct pressure for 4 minutes, in a circular manner at the rate of 3 - 4 kg. Released pressure for 2 minutes, applied again for 4 minutes. In the same way, the massage is repeated for the right foot. Three massage sessions will be performed per week, for four weeks (12 sessions). Intervention 2: Intervention group: Acupressure group: in this group, in addition to the usual care in the hemodialysis department, acupressure is performed. After one hourof the start of hemodialysis, the researcher determines three acupressure points (K1, ST36 and SP6) in each leg at the room temperature. When the sole of the foot is bent, the K1 point is located in the depression of the sole between the second and third toes and approximately 1 / 3 of the distance between the base of the second toe and the heel. The SP6 point is located four toes above the inner ankle, just behind the tibia. The ST36 point is located four fingers below the kneecap and on the outside of the tibia. The researcher applied pressure at each point with the thumb of the hand at a speed of two rotations per second for 3 minutes so that the patient felt vague pain, tingling and warmth in the point. At this moment, the acupuncture point is stimulated to induce "Chi". In the same way, acupressure is repeated for the right leg (9 minutes for each leg, 18 minutes in total).Three acupressure sessions will be performed per week, for four weeks (12 sessions). Intervention 3: Control group: Only the routine care of the hemodialysis department is performed.</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>Zahra Bakhshizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Blvd., Bandar Abbas.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 3280</telephone>
        <email>zahra.bakhshizade94@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Bakhshizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Blvd., Bandar Abbas.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 3333 3280</telephone>
        <email>zahra.bakhshizade94@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
At least 3 months history of hemodialysis
Perform hemodialysis three times per week
Having full consciousness and the ability to listen and speak</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Severe mental disorder and the use of sedatives
Occurrence of stressful events such as death of first-degree relatives, divorce and conflict in legal issues in the last six months
Suffering from chronic and debilitating diseases (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, systemic lupus erythematosus)
Having amputations, wounds, swelling, burns, and fractures at the intervention site</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Reflexology group: in this group, in addition to the usual care in the hemodialysis department, foot reflexology massage is performed. After one hour of the start of hemodialysis, the researcher holds the heel of the patient's left foot with his left hand at the room temperature and bends and straightens it from the wrist by pressing on the sole of the foot, then with the thumb of the right hand (thumb pulp) on The solar plexus point (right below the sole of the foot at the junction of the anterior 1 / 3 and the posterior 2 / 3 of the sole in the midline) will apply direct pressure for 4 minutes, in a circular manner at the rate of 3 - 4 kg. Released pressure for 2 minutes, applied again for 4 minutes. In the same way, the massage is repeated for the right foot. Three massage sessions will be performed per week, for four weeks (12 sessions).</i_keyword>
      <i_keyword>Intervention group: Acupressure group: in this group, in addition to the usual care in the hemodialysis department, acupressure is performed. After one hourof the start of hemodialysis, the researcher determines three acupressure points (K1, ST36 and SP6) in each leg at the room temperature. When the sole of the foot is bent, the K1 point is located in the depression of the sole between the second and third toes and approximately 1 / 3 of the distance between the base of the second toe and the heel. The SP6 point is located four toes above the inner ankle, just behind the tibia. The ST36 point is located four fingers below the kneecap and on the outside of the tibia. The researcher applied pressure at each point with the thumb of the hand at a speed of two rotations per second for 3 minutes so that the patient felt vague pain, tingling and warmth in the point. At this moment, the acupuncture point is stimulated to induce "Chi". In the same way, acupressure is repeated for the right leg (9 minutes for each leg, 18 minutes in total).Three acupressure sessions will be performed per week, for four weeks (12 sessions).</i_keyword>
      <i_keyword>Control group: Only the routine care of the hemodialysis department is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score of hemodialysis patients. Timepoint: At the beginning of the study (before the start of the intervention), one hour after the start of each hemodialysis session, at the end of each hemodialysis session. Method of measurement: Visual Fatiue Scale.</prim_outcome>
      <prim_outcome>Fatigue score of hemodialysis patients. Timepoint: At the beginning of the study (before the start of the intervention), at the end of sessions 3, 6, 9 and 12 of the intervention. Method of measurement: Piper Fatigue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The anxiety score of hemodialysis patients. Timepoint: At the beginning of the study (before the start of the intervention), at the end of sessions 3, 6, 9 and 12 of the intervention. Method of measurement: Hospital Anxiety and Depression Scale.</sec_outcome>
      <sec_outcome>The depression score of hemodialysis patients. Timepoint: At the beginning of the study (before the start of the intervention), at the end of sessions 3, 6, 9 and 12 of the intervention. Method of measurement: Hospital Anxiety and Depression Scale.</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>Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-27</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Hormozgan University of Medical Sciences, Faculty of Nursing and MidwiferyShahid Chamran Blvd., Bandar Abbas. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
