<?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>IRCT20221130056669N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-06</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Virtual Reality on Anxiety, Depression, Stress and Death anxiety in Elderly</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Virtual Reality On Anxiety, Depression, Stress and Death Anxiety in Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67138</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Randomization description: The sampling procedure involves the use of cluster sampling to select health centers. Once the clusters are identified, a random sample is selected from them, with the number of clusters chosen based on the desired sample size. Health centers within each selected cluster are then included in the sample. Eligible elderly participants from these health centers are then randomly allocated into blocks of four and assigned to either the control or intervention group. This is done after they have met the entry criteria for the study. Random allocation into blocks of four means that for every four eligible elderly participants, two are randomly assigned to the intervention group and two to the control group. The randomization process is done using a computer-generated random number sequence. The blocks of four ensure that there are an equal number of participants in each group, which can help to reduce the risk of chance imbalances between the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety. Condition 3: Stress. Condition 4: Death anxiety.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will be using Samsung VR devices to be placed in a virtual reality environment. The virtual reality environment will consist of different settings, including natural landscapes, pilgrimage sites, historical sites, tourist sites, and deep sea or flight scenarios. The participants in the intervention group will interact with the virtual environment, which will be under the control of the researcher, and the intervention will take place in a quiet room that respects the privacy of the participants. The intervention will consist of six 15-minute sessions, conducted twice a week for three weeks, and will be held in the health centers. Intervention 2: Control group: No intervention is done.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadamin Shahrbaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Farzmahdi Alley., Padegan Ave.,</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413843686</zip>
        <telephone>+98 28 3335 6985</telephone>
        <email>Mohammadaminshahrbaf@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadamin Shahrbaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Farzmahdi Alley., Padegan Ave.,</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413843686</zip>
        <telephone>+98 28 3335 6985</telephone>
        <email>Mohammadaminshahrbaf@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals aged 60 years and older
Reading and writing literacy in Persian language
Interest and informed consent to participate in the study
Absence of visual, auditory, or tactile impairments
Achieving a score of eight or above on the Abbreviated Mental Test (AMT)
Absence of psychological disorders as determined by both file records and self-reported measures
Absence of current use of psychiatric medications or narcotics as determined by both file records and self-reported measures.
Absence of medical history pertaining to conditions such as epilepsy, dizziness, and convulsions, as confirmed by both file records and self-reported measures.
Absence of self-reported prior participation in comparable programs
Achieving a score of 14 or greater on the depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21).
Achieving a score of 10 or greater on the Anxiety subscale of the Depression Anxiety Stress Scale-21(DASS-21)
Achieving a score 19 or greater on the Stress subscale of the Depression Anxiety Stress Scale-21(DASS-21)
Achieving a score 7 and above in the Tampler Death anxiety Scale (DAS)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensory impairments in vision, hearing, and tactile
Suffering from psychological disorders, according to the file and self-report
Taking psychiatric medicine and narcotics according to the file and self-report
Having a history of diseases such as epilepsy, dizziness and convulsions according to the file and self-report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.8</hc_code>
      <hc_code>F41</hc_code>
      <hc_code>F43.8</hc_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other depressive episodes</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Other reactions to severe stress</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will be using Samsung VR devices to be placed in a virtual reality environment. The virtual reality environment will consist of different settings, including natural landscapes, pilgrimage sites, historical sites, tourist sites, and deep sea or flight scenarios. The participants in the intervention group will interact with the virtual environment, which will be under the control of the researcher, and the intervention will take place in a quiet room that respects the privacy of the participants. The intervention will consist of six 15-minute sessions, conducted twice a week for three weeks, and will be held in the health centers.</i_keyword>
      <i_keyword>Control group: No intervention is done</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score from depression subscale, short form of depression, anxiety and stress scale. Timepoint: Before and after the intervention. Method of measurement: Short form of depression, anxiety and stress scale(DASS-21).</prim_outcome>
      <prim_outcome>Score from َanxiety subscale, short form of depression, anxiety and stress scale. Timepoint: Before and after intervention. Method of measurement: Short form of depression, anxiety and stress scale(DASS-21).</prim_outcome>
      <prim_outcome>Score from َstress subscale, short form of depression, anxiety and stress scale. Timepoint: Before and after intervention. Method of measurement: Short form of depression, anxiety and stress scale (DASS-21).</prim_outcome>
      <prim_outcome>Score from َTampler Death anxiety scale. Timepoint: Before and after intervention. Method of measurement: Tampler Death anxiety scale (DAS).</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-27</approval_date>
        <contact_name>Ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Nursing and Midwifery School., Imam Sajjad Hospital.,  Shahid Motahari St Ramsar Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
