<?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>IRCT20180608040007N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>the effect of mental imagery on COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mental imagery on anxiety and sleep quality in patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49938</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Patients are divided into two groups of intervention and control by census method with simple random assignment. Based on the time of filing in the admission unit, the patients who meet the inclusion criteria are selected from the infectious wards. Then, individual patients will be in the intervention group and paired patients will be in the control group, respectively. Sampling will continue until the total number of patients reaches 70 (35 patients in the intervention group and 35 patients in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 15 minutes are explained about mental imagery, and then in a 45-minute session, first muscle relaxation is performed and then mental imagery is performed under the guidance of the researcher. Perform the mental imagery steps and the content expressed by the patient's mobile phone and the participant is asked to listen to this recorded sound every day for three weeks and do mental imagery. In addition, perform tasks related to mental imagery identified by the researcher. Post-test in both groups will be completed by telephone by the researcher and research colleague by phone within 15 to 20 minutes four weeks after the intervention. Intervention 2: Control group: .Control group: Due to the critical conditions and the possibility of rapid disease transmission, all safety conditions are observed to prevent the transmission of infection among patients and the researcher. In the control group, after completing the consent form, the pre-test is completed in a quiet and private environment, which is intended for all patients (intervention and control). The pre-test is answered by the patient in 15 to 20 minutes. Routine Covid-19 treatments continue in both groups according to the hospital infectious disease specialist. In the control group, only routine procedures are performed according to the doctor's instructions. The post-test is completed three weeks later by the researcher and research partner over a period of 15 to 20 minutes by telephone.</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:
The main consequences will be shared upon formal request.

When:
6 months after the article is published, it will be shared upon official request.

To whom:
Researchers working in academic and scientific institutions will be shared upon formal request.

Conditions:
It will be shared upon formal request and use cases after review.

Where to obtain:
ba_zendegy@yahoo.com

How to obtain:
After the official request, the determination of the uses will be provided after at least one month after the review and approval of the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>ba_zendegy@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>ba_zendegy@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients admitted to infectious wards due to Covid 19
No hearing, vision or speech impairment
Do not use drugs and alcohol
Participants' self-declaration for: no depression, no use of antipsychotic drugs
Having a mobile phone</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of stressful events such as: death of loved ones, tragic events
Tendency to end treatment
Deterioration of the patient and the need for hospitalization in the ICU</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 15 minutes are explained about mental imagery, and then in a 45-minute session, first muscle relaxation is performed and then mental imagery is performed under the guidance of the researcher. Perform the mental imagery steps and the content expressed by the patient's mobile phone and the participant is asked to listen to this recorded sound every day for three weeks and do mental imagery. In addition, perform tasks related to mental imagery identified by the researcher. Post-test in both groups will be completed by telephone by the researcher and research colleague by phone within 15 to 20 minutes four weeks after the intervention.</i_keyword>
      <i_keyword>Control group: .Control group: Due to the critical conditions and the possibility of rapid disease transmission, all safety conditions are observed to prevent the transmission of infection among patients and the researcher. In the control group, after completing the consent form, the pre-test is completed in a quiet and private environment, which is intended for all patients (intervention and control). The pre-test is answered by the patient in 15 to 20 minutes. Routine Covid-19 treatments continue in both groups according to the hospital infectious disease specialist. In the control group, only routine procedures are performed according to the doctor's instructions. The post-test is completed three weeks later by the researcher and research partner over a period of 15 to 20 minutes by telephone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety reduction based on Beck questionnaire. Timepoint: Measurement of anxiety, before intervention and one month after intervention. Method of measurement: Beck Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Increase sleep quality. Timepoint: Measurement of sleep quality, before intervention and one month after 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-09</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Central Administration, Bahonar Sq., Shahid Sadoughi University of Medical Sciences, Yazd Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
