<?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>IRCT20190515043601N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-06</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acupressure on anxiety, depression and stress of primary Family Caregivers of Stroke Survivors</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Acupressure on anxiety, depression and stress of primary Family Caregivers of Stroke Survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization, Blinding description: This study is a single-blind clinical trial. Those who evaluate the outcome and analyze the data will be blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: Anxiety. Condition 3: Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants in this study will be the primary caregiver of patients with stroke in birjand city. 46 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. The DASS 42 questionnaire will be completed one day after the end of the intervention. Intervention 2: Sham group: 46 patients will be included in the sham group. Participants will press the CV24 and  TB5 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. The DASS 42 questionnaire will be completed one day after the end of the intervention.</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:
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.

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

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>9717853577</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>Age of primary caregiver 60-18 year
Ability to read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of physical ability
Lack of desire to continue participating in research
Change the main caregiver
Eliminate the role of the main caregiver</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.9</hc_code>
      <hc_code>F06.4</hc_code>
      <hc_code>F06.31</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>
    </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: The participants in this study will be the primary caregiver of patients with stroke in birjand city. 46 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. The DASS 42 questionnaire will be completed one day after the end of the intervention.</i_keyword>
      <i_keyword>Sham group: 46 patients will be included in the sham group. Participants will press the CV24 and  TB5 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. The DASS 42 questionnaire will be completed one day after the end of the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of stress in primary caregivers of patients with stroke. 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 primary caregivers of patients with stroke. Timepoint: Before and one day after the end of intervention. Method of measurement: Anxiety score from the depression, anxiety and stress scale-42.</prim_outcome>
      <prim_outcome>The level of depression in primary caregivers of patients with stroke. Timepoint: Before and one day after the end of intervention. Method of measurement: Depression score from the depression, anxiety and stress scale-42.</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>2019-11-27</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Science</contact_name>
        <contact_address>Ayatollah Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
