<?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>IRCT20231016059742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Foot Reflexology Massage On Fatigue And Sleep Quality  In Hemodialysis Patients: A Randomized Control Trial</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Foot Reflexology Massage On Fatigue And Sleep Quality  In Hemodialysis Patients: A Randomized Control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73354</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample number of 50 people (hemodialysis patients) will be selected by the available method and will be divided into two intervention and control groups (25 people in each group) using the minimization random allocation method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatigue and sleep quality in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the intervention group will receive foot reflexology massage three sessions a week (for 3 weeks) and each session lasts 16 minutes (each foot massage lasts 8 minutes). At this stage, the patient is placed in a semi-sitting position and his sole The reflexologist is placed parallel to the chest, the patient is asked to close his eyes and be in a relaxed position. Then the masseur, who is the same gender as the patient, performs reflex massage on the solar retina and the pineal gland area on the inner upper part of the soles and big toes. In this way, 1 minute of general massage in each leg, 3 minutes of reflex massage in each area in each leg and 1 minute of rest in between. Intervention 2: For patients in the control group, the sham group will be considered and only simple touch will be done without putting pressure on specific points.</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:
Demographic data including age and gender and disease related information

When:
Start high-speed access after printing

To whom:
public

Conditions:
Statistical analysis and use of questionnaires

Where to obtain:
Applicants for project documentation should send a message to the responsible author, Mrs. Rahela Rajabi, by email r.rajabi@kmu.ac.ir and provide her with a summary of her project along with the demographics and after reading the relevant information. will take

How to obtain:
Sending an email of the abstract of the project along with the sampling method and statistical population to the responsible author of the study and approval of the qualification by the responsible author. After the project is completed, it is necessary to provide its details to the responsible author. One month after receiving the email from the project author, the responsible author will provide the necessary information to them.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>raheleh rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>emam khomeini street</address>
        <city>zarand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3342 5400</telephone>
        <email>rahelehr48@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>raheleh rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>emam khomeini street</address>
        <city>zarand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3342 5400</telephone>
        <email>rahelehr48@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
Dialysis treatment for at least 3 months
Treatment with hemodialysis 3 times a week and each time for 4 hours
Not suffering from chronic and debilitating diseases (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus erythematosus)
No obvious physical disability or mental disorder that the person cannot take care of himself</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 18 years
Treatment with dialysis less than 3 months
Having a limb amputation or wound at the massage site
Suffering from chronic and debilitating diseases (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus erythematosus)
Physical disability or obvious mental disorder that makes the person unable to take care of themselves</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the intervention group will receive foot reflexology massage three sessions a week (for 3 weeks) and each session lasts 16 minutes (each foot massage lasts 8 minutes). At this stage, the patient is placed in a semi-sitting position and his sole The reflexologist is placed parallel to the chest, the patient is asked to close his eyes and be in a relaxed position. Then the masseur, who is the same gender as the patient, performs reflex massage on the solar retina and the pineal gland area on the inner upper part of the soles and big toes. In this way, 1 minute of general massage in each leg, 3 minutes of reflex massage in each area in each leg and 1 minute of rest in between.</i_keyword>
      <i_keyword>For patients in the control group, the sham group will be considered and only simple touch will be done without putting pressure on specific points.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental or physical feeling affecting people's functioning. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Providing Piper s fatigue scale questionnaire to the participants.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Enjoying a person's sleep with the highest functional level. Timepoint: Before the start and at the end of the intervention. Method of measurement: Providing  PSQI questionnaires to people.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-07</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini street zarand Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
