<?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>IRCT20190515043601N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-04</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46571</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 106 patients who met inclusion criteria will be randomly assigned to intervention and control groups using the coin toss. All the eligible patients will be included in the study from November 2019 to April 2020 (The Poisson simple random sampling). The first five patients will be allocated to the intervention (head) or control (tail) group, and the second five patients will be allocated to the other group (tails) using tossing a coin. c), Blinding description: The data analyst will be unaware of the type of intervention for each group.Pre-intervention questionnaires will be coded in the intervention group with the letter M and the control group with N. Questionnaires will be coded after intervention in intervention group with letter G and control group with H.The coding will be done by the researcher.No one other than the researcher will know about coding.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: anxiety. Condition 3: depression. Condition 4: fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants in this study will be MS patients in Mashhad. Intervention group:53 patients will be included in the intervention group. Participants will press the HT7 and GV29 acupressure points.The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. One day after the intervention, patients will complete the  DASS42  and FSS questionnaires. Intervention 2: Control group: i participantswill press 2.5 cm above shenmen and 3 cm above Yin Tang  acupoints .</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:
All potential data can be shared after unidentifiable participants

When:
Start of access period 12 months after printing results

To whom:
It will only be available to researchers working in academic and scientific institutions

Conditions:
In order to access the data, researchers can request access to the information 12 months after the results are published. Within two weeks, the information will be sent to them.It should be noted that applicants must be faculty members of the Ministry of Health.

Where to obtain:
Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.

How to obtain:
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717852577</zip>
        <telephone>+98 56 3238 1427</telephone>
        <email>Hosseinrahimi92@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3238 1427</telephone>
        <email>Hosseinrahimi92@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Relapsing Remitting MS
At least 6 months have passed since the diagnosis of MS
Maximum age 45 years
EDSS scores 1 to 4.5</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of psychosis
Addiction to narcotics, stimulants ,sedatives drugs and tobacco
Acne, ulcer or skin lesions in acupressure points</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.9</hc_code>
      <hc_code>F06.4</hc_code>
      <hc_code>F06.31</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Reaction to severe stress, unspecified</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword>Mood disorder due to known physiological condition with depressive features</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants in this study will be MS patients in Mashhad. Intervention group:53 patients will be included in the intervention group. Participants will press the HT7 and GV29 acupressure points.The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. One day after the intervention, patients will complete the  DASS42  and FSS questionnaires.</i_keyword>
      <i_keyword>Control group: i participantswill press 2.5 cm above shenmen and 3 cm above Yin Tang  acupoints .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of stress in MS patients. Timepoint: Before and one day after the end of intervention. Method of measurement: Stress score from the depression, anxiety and stress scale-42.</prim_outcome>
      <prim_outcome>The level of anxiety in MS patients. Timepoint: Before and one day after the end of intervention. Method of measurement: Anxiety score from the depression, anxiety, stress scale-42.</prim_outcome>
      <prim_outcome>The level of depression in MS patients. Timepoint: Before and one day after the end of intervention. Method of measurement: Depression score from the depression, anxiety, stress scale-42.</prim_outcome>
      <prim_outcome>The level of fatigue in MS patients. Timepoint: Before and one day after the end of intervention. Method of measurement: Fatigue score from the Fatigue severity scale.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-14</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Central Building of Birjand University of Medical Sciences, Ghorfari Street, Birjand, South Khorasan Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
