<?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>IRCT20210723051959N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-06</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>The effect of effleurage massage and foot reflexology training on quality of life in patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of effleurage massage and foot reflexology training on quality of life in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation of 45 patients in use according to inclusion and exclusion criteria, randomly into three intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Effleurage massage will be performed in the patient's home and place suitable in terms of humidity and heat by the caregiver. Effleurage massage with two Drops of Sweet almonds oil will be done for 10 minutes on each leg to prepare the person and create relaxation in the thigh and hip muscles and calf and sole muscles. Effleurage massage will include slow, rhythmic, and gentle movements, usually blood flow to the heart. And a superficial pressure will be applied by the palm to the skin of the patient's body during reciprocating movements, so the total duration of the session will be 20 minutes. Intervention 2: Intervention group 2: in the Reflexology group, using a silicone marker, reflective points on the head, neck, solar plexus, pelvis, shoulders, pituitary gland, hip, adrenal glands, On the sole, by the index finger and thumb, pressure with a depth of 2-3 mm and regular rhythm and round and approaching the two toes and pointing will be done at the point of reflection, the time allotted for the pressure of the reflective points for each The foot will be 10 minutes, so the total duration of the massage in each session will be 20 minutes. Then the FSS fatigue score will be measured by the caregiver immediately after each session and, the pain scores one hour and, the results will be sent to the researcher via SMS by the caregiver. Intervention 3: Control group:  to simulate the processes performed in the intervention groups, will lubricate each sole with emollient ointment for 10 minutes 3 times a week for eight weeks, so the length of Each session in this group will be 20 minutes.</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:
Information about the original and secondary consequence

When:
6 months after accepting of article

To whom:
Researchers working at the university and scientific institutions

Conditions:
Requires data to do similar research

Where to obtain:
Fatemeh Akbari: fafa_ak@yahoo.com
Mahsa Haji Hosseini: MAHSA.NMSPRG@GMAIL.COM

How to obtain:
Email / Check the reason for content request and file / approval by the executive and colleagues / send the file

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Haji Mohammad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 83, University Jihad Alley, Safashahr St, Qom.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93456-37169</zip>
        <telephone>+98 25 3285 2720</telephone>
        <email>MAHSA.NMSPRG@GMAIL.COM</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Haji Mohammad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 83, University Jihad Alley, Safashahr St, Qom.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93456-37169</zip>
        <telephone>+98 25 3285 2720</telephone>
        <email>MAHSA.NMSPRG@GMAIL.COM</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with MS, in the age group of 18 years and older, are members of the Qom MS Association and please to participate in this study.
Fatigue score equal to or Greater than four according to Fatigue Severity Scale
Pain score equal to or Greater than four, according to the Analogue Visual Scale (Vas)
Extensive disability score 2-6 according to the Expanded Disability Status Scale
Ability to walk comfortably at least 10 meters, with support if needed
Ability to stand for at least 60 seconds, with an attendant if needed
patients who have not used complementary therapies in the last six months
patients who are not prohibited from massage and do not have wounds and skin problems that interfere with the message
those who do not have fractures, thrombosis, and arthritis in the foot area
No drug addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and taking it during the study
Inability to massage by the companion
hypotension, unstable cardiovascular conditions
If the patient informs the researcher that they used Analgesics or antidepressants during the study, will be excluded them
History of hypothyroidism
Neuromuscular diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disseminated Multiple Sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Effleurage massage will be performed in the patient's home and place suitable in terms of humidity and heat by the caregiver. Effleurage massage with two Drops of Sweet almonds oil will be done for 10 minutes on each leg to prepare the person and create relaxation in the thigh and hip muscles and calf and sole muscles. Effleurage massage will include slow, rhythmic, and gentle movements, usually blood flow to the heart. And a superficial pressure will be applied by the palm to the skin of the patient's body during reciprocating movements, so the total duration of the session will be 20 minutes</i_keyword>
      <i_keyword>Intervention group 2: in the Reflexology group, using a silicone marker, reflective points on the head, neck, solar plexus, pelvis, shoulders, pituitary gland, hip, adrenal glands, On the sole, by the index finger and thumb, pressure with a depth of 2-3 mm and regular rhythm and round and approaching the two toes and pointing will be done at the point of reflection, the time allotted for the pressure of the reflective points for each The foot will be 10 minutes, so the total duration of the massage in each session will be 20 minutes. Then the FSS fatigue score will be measured by the caregiver immediately after each session and, the pain scores one hour and, the results will be sent to the researcher via SMS by the caregiver.</i_keyword>
      <i_keyword>Control group:  to simulate the processes performed in the intervention groups, will lubricate each sole with emollient ointment for 10 minutes 3 times a week for eight weeks, so the length of Each session in this group will be 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and at the end of the Study. Method of measurement: MSQOL-54(Multiple Sclerosis Quality of Life-54).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain score. Timepoint: Before the intervention, after each intervention session, at the end of the study. Method of measurement: Visual analogue scale.</sec_outcome>
      <sec_outcome>Fatigue score. Timepoint: Before the intervention, after each intervention session, at the end of the study. Method of measurement: Fatigue Severity Scale.</sec_outcome>
      <sec_outcome>Walking speed. Timepoint: Before the intervention and at the end of the study. Method of measurement: Timed 25-Foot Walk.</sec_outcome>
      <sec_outcome>Fatigue score. Timepoint: Before the intervention and at the end of the study. Method of measurement: Fatigue Impact 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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-13</approval_date>
        <contact_name>Research Ethics Committees of Qom University of Medical Sciences</contact_name>
        <contact_address>No. 83, 1/1 Alley, Safashahr St, Qom town Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
