<?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>IRCT20190528043741N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-18</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect Of Massage With Lavender Oil And Simple Massage On Cramping Pain Severity And Fatigue in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Massage With Lavender Oil And Simple Massage On Cramping Pain Severity And Fatigue in Hemodialysis Patients In Lordegan And Borujen Cities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: With the help of random allocation software, 60 patients were selected.After justifying the patients to participate in the study and obtain informed consent, the samples were randomly divided into two groups of 30, Blinding description: In this study, the participants in the study (patients), nurses working in the hemodialysis departments and the statistical advisor (data analyst) were kept blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Muscle cramps during hemodialysis. Condition 2: Fatigue during hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Massage with lavender oil. Lavender oil massage was used with 10 drops of 1/5% lavender oil. Massage duration was 5 minutes and three times: one hour after dialysis, two hours after dialysis, and half an hour to the end of dialysis-Most cramps occur at this time-(15 minutes total). The massage was done in such a way that the nurse's fingers were placed around the C and the massage was performed.The back muscles were selected for massage. Intervention 2: Control group: Massage with olive oil.For massage, olive oil was used.Massage duration was 5 minutes and three times: one hour after dialysis, two hours after dialysis, and half an hour to the end of dialysis-Most cramps occur at this time-(15 minutes total). The massage was done in such a way that the nurse's fingers were placed around the C and the massage was performed.The back muscles were selected for massage.</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:
Data on major outcomes can be shared.

When:
from 2020 to 2025

To whom:
Researchers working in academic and scientific institutions

Conditions:
For the manufacture of drugs effective on fatigue and muscle cramps during hemodialysis

Where to obtain:
Shahrekord University of Medical Sciences- Shohada Lordordan Hospital- Mr. Mohammad Alidadi. Email: Bakhtiary95@gmail.com  mobile: 09132805386

How to obtain:
Sent emails will be answered within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Alidadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street. Lordegan Shohada Hospital</address>
        <city>Lordegan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8891635133</zip>
        <telephone>+98 38 3444 4444</telephone>
        <email>Bakhtiary95@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Alidadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse  Street. Lordegan Shohada Hospital</address>
        <city>Lordegan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8891635133</zip>
        <telephone>+98 38 3444 4444</telephone>
        <email>Bakhtiary95@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having chronic renal failure with at least one year of hemodialysis history
Age range from 30 to 60 years
Having physical and mental ability
Loss of skin lesions, ulcers and redness of the limbs</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disease with catabolic processes like cancer
Diabetic Neuropathy
Taking medications, sleep deprivation, drugs and nerves
Skin disorders of the lower limb, musculoskeletal disorders and known arthritis
Lavender oil allergy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.0</hc_code>
      <hc_code>Z49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preparatory care for renal dialysis</hc_keyword>
      <hc_keyword>Preparatory care for renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Massage with lavender oil. Lavender oil massage was used with 10 drops of 1/5% lavender oil. Massage duration was 5 minutes and three times: one hour after dialysis, two hours after dialysis, and half an hour to the end of dialysis-Most cramps occur at this time-(15 minutes total). The massage was done in such a way that the nurse's fingers were placed around the C and the massage was performed.The back muscles were selected for massage.</i_keyword>
      <i_keyword>Control group: Massage with olive oil.For massage, olive oil was used.Massage duration was 5 minutes and three times: one hour after dialysis, two hours after dialysis, and half an hour to the end of dialysis-Most cramps occur at this time-(15 minutes total). The massage was done in such a way that the nurse's fingers were placed around the C and the massage was performed.The back muscles were selected for massage.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscular cramps during hemodialysis: A score obtained from patients about the severity of pain after hemodialysis, which is measured by the visual scale of pain. Timepoint: At the beginning of the study, 7-14-21 and 28 days after the study. Method of measurement: Visual analogue Scale Questionnaire.</prim_outcome>
      <prim_outcome>Fatigue: A patient's fatigue score measured by Piper's Fatigue Questionnaire. Timepoint: At the beginning of the study, 7-14-21 and 28 days after the study. Method of measurement: Piper Fatigue Questionnaire.</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>Yazd university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-15</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Central Building of Yazd University of Medical Sciences. Yazd, Bahonar Square, Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
