<?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>IRCT20240618062169N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-22</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Efflorescence massage with and without black seed oil on hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the comparative effect of effleurage massage with and without black seed oil on the sleep quality of restless leg syndrome patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77461</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use simple random sampling. The sampling method will be as follows: 56 sheets (A = test) and (B = control) will be provided in equal form and placed in envelopes of the same shape and sealed. Then the eligible patients are asked to take an envelope from the bag containing the envelopes and they are placed in one of the two control or test groups based on the luck of the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Restless leg syndrome in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participating patients in the intervention group, along with their companions, will be taught how to perform effleurage massage in two face-to-face training sessions. Also, the patients of the test group will be asked to perform effleurage massage using 10 cc of black seed oil with a concentration of 5% from Tubi company. The patients of the test group will be asked to massage both legs for 4 weeks, 3 times a week, and a total of 12 sessions, each time for 20 minutes, one hour before going to bed. In addition, a group will be formed on Rubik's and WhatsApp , and for patients in the intervention group, links to educational materials related to effleurage  massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher. Intervention 2: Control group: Participating patients in the control group, along with their companions, will see face-to-face training on how to perform effleurage massage in two training sessions. The patients of the control group will be asked to massage 3 times a week for 4 weeks and a total of 12 sessions, each time for 20 minutes on both legs, one hour before going to bed. In addition, a group will be formed on Rubik's messengers, and for patients in the intervention group, links to educational materials related to effleurage massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher.</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 "No more information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayyaba Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Daneshgah Ave, Dadafrid St, in front of Qamar Bani Hashem High School</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817846868</zip>
        <telephone>+98 86 3324 8179</telephone>
        <email>tybhqsmy654@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Jadidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>646</zip>
        <telephone>009886331360558</telephone>
        <email>JADIDI.ALI83@YAHOO.COM</email>
        <affiliation>Arak 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 the age of 18 to 65 years
Hemodialysis should be performed for patients at least 3 times a week and for 4 hours each time
Not having physical and mental sensitivity to massage
Not having cardiovascular and skin disease
Not having psychological disorders such as depression and bipolar disorders
Not having heart failure, lupus erythematosus
Not having debilitating and chronic diseases such as various cancers and rheumatoid arthritis.
No diabetic foot ulcers and orthopedic problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use Sedative drug</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participating patients in the intervention group, along with their companions, will be taught how to perform effleurage massage in two face-to-face training sessions. Also, the patients of the test group will be asked to perform effleurage massage using 10 cc of black seed oil with a concentration of 5% from Tubi company. The patients of the test group will be asked to massage both legs for 4 weeks, 3 times a week, and a total of 12 sessions, each time for 20 minutes, one hour before going to bed. In addition, a group will be formed on Rubik's and WhatsApp , and for patients in the intervention group, links to educational materials related to effleurage  massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher.</i_keyword>
      <i_keyword>Control group: Participating patients in the control group, along with their companions, will see face-to-face training on how to perform effleurage massage in two training sessions. The patients of the control group will be asked to massage 3 times a week for 4 weeks and a total of 12 sessions, each time for 20 minutes on both legs, one hour before going to bed. In addition, a group will be formed on Rubik's messengers, and for patients in the intervention group, links to educational materials related to effleurage massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score in the Pittsburgh Questionnaire. Timepoint: The beginning of the intervention (before the start of the intervention), 4 weeks after the start of the intervention. Method of measurement: Pittsburgh Sleep Quality 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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-02</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
