<?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>IRCT20190625044009N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of floating feet in warm water and foot reflexology on fatigue and sleep quality in patients under radiotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of floating feet in warm water and foot reflexology on fatigue and sleep quality in patients under radiotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40647</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization type: Simple
This method uses computer randomization methods and divides people into two groups randomly by sequences generated by spss software. 
The method of concealing Allocation Concealment is done by the statistics consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Caner.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1 : In the group of floating legs in warm water, patients from the seventh day after starting radiotherapy every night for two weeks  an hour before normal sleep hours (between 9 to 10 pm) float their legs 10 cm above the wrist in water (41 to 42 ° C) for 20 minutes Inside the plastic container with a size of 40 × 27 × 45. Intervention 2: Intervention group2:Intervention is performed for two weeks from the seventh day after starting radiotherapy every night for 10 minutes with olive oil for each foot massage. Reflexology intervention includes preparation, warm-up and stimulation and massage techniques which is done at the point of the solar plexus at the end of the first metatarsal bone of the foot to reduce fatigue, and at the pituitary gland and pineal gland at the toe to improve sleep quality. Massage duration for each foot is 10 minutes.( 1 minute general foot massage and each area 3 minutes). The pressure is 4 to 5 kilogram, which the intervener calibrates by applying pressure on a digital scale to the amount of pressure on his hand. The patient should lie on the bed in a supine position so that the floor of both feet is at the end of the bed and is fully exposed and the intervener sits on a chair at the end of the bed so that the patient's foot is in front of her and in complete control.</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:
Presentation of research findings in seminars, conferences and publishing articles extracted from research, in magazines at home and abroad for use by cancer patients as well as researchers who intend to conduct research on the subject.

When:
Start of access period 6 months after printing results

To whom:
Share the results of the research with other researchers for further research.

Conditions:
The results obtained in this study can be used in the oncology wards of all hospitals and even in other wards, especially in chronic patients who require specific medications following the consequences of their long-term treatment and intensive care.

Where to obtain:
Mashhad School of Nursing and Midwifery

How to obtain:
After the email is sent to the scientifically responsible person, the accountability process begins.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahla Rajabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, plate 100, Imamate 47, Imamate Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188695612</zip>
        <telephone>+98 51 3601 6795</telephone>
        <email>rajabzadehm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahla Rajabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, plate 100, Imamate 47, Imamate Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188695612</zip>
        <telephone>+98 51 3601 6795</telephone>
        <email>rajabzadehm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To perform radiotherapy, refer to the center of Imam Reza Mashhad
Age is between 18 and 60 years old
Is alert
Stage cancer is zero, one, two or three, and non-metastatic.(Based on diagnostic tests, signs and clinical examinations and approval of an oncology specialist)
There is no peripheral vascular disease, such as peripheral vascular thrombosis, burger disease, diabetes, ulcers, infection or cancer and foot radiotherapy and peripheral sensory loss
Do not use hypnotic and sedative drugs
There is no history of hospitalization for psychiatric causes (Stress, anxiety, Depression)
The phone number has been provided to the researcher for follow up
At the same time, chemotherapy and other therapies, including hormone therapy,Target therapy, heat therapy, and cold therapy are not used
During the period of radiotherapy, Patient will stay at the Reza Health Center nursing home
In response to the Smith's Fatigue Questionnaire, patient earns a score of 30 and above
In response to the Pittsburgh Sleep Quality Questionnaire, patient earns a score of 5 and above</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm without specification of site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1 : In the group of floating legs in warm water, patients from the seventh day after starting radiotherapy every night for two weeks  an hour before normal sleep hours (between 9 to 10 pm) float their legs 10 cm above the wrist in water (41 to 42 ° C) for 20 minutes Inside the plastic container with a size of 40 × 27 × 45</i_keyword>
      <i_keyword>Intervention group2:Intervention is performed for two weeks from the seventh day after starting radiotherapy every night for 10 minutes with olive oil for each foot massage. Reflexology intervention includes preparation, warm-up and stimulation and massage techniques which is done at the point of the solar plexus at the end of the first metatarsal bone of the foot to reduce fatigue, and at the pituitary gland and pineal gland at the toe to improve sleep quality. Massage duration for each foot is 10 minutes.( 1 minute general foot massage and each area 3 minutes). The pressure is 4 to 5 kilogram, which the intervener calibrates by applying pressure on a digital scale to the amount of pressure on his hand. The patient should lie on the bed in a supine position so that the floor of both feet is at the end of the bed and is fully exposed and the intervener sits on a chair at the end of the bed so that the patient's foot is in front of her and in complete control.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention began. Method of measurement: Smith's Fatigue Questionnaire.</prim_outcome>
      <prim_outcome>Sleep Quality. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention began. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: At the beginning of the study (before the  intervention) and on the 28th day of the radiotherapy course. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: At the beginning of the study (before the  intervention) and on the 28th day of the radiotherapy course. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</sec_outcome>
      <sec_outcome>Stress. Timepoint: At the beginning of the study (before the  intervention) and on the 28th day of the radiotherapy course. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: At the beginning of the study (before the  intervention) and on the 28th day of the radiotherapy course. Method of measurement: Quality of Life Questionnaire of European Organization for Research and Treatment of Cancer.</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>2019-05-28</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Doktora four-way, Ebn Sina Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
