<?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>IRCT20260623069931N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Virtual Reality Sports Tourism</public_title>
      <acronym>VRST</acronym>
      <scientific_title>Solo versus Group-Based Virtual Reality Sports Tourism for Reducing Loneliness in Widowed Older Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>115</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study will be conducted as a three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Participants will be allocated to one of three groups: usual care/control, solo virtual reality sports tourism, or group-based virtual reality sports tourism. Assessments will be conducted at three time points: baseline, immediately after the four-week intervention, and 30 days after the final session. Outcome assessors will be blinded to group allocation, but participants and facilitators will not be blinded because of the nature of the virtual reality intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Loneliness among widowed older women living in nursing homes.</hc_freetext>
      <i_freetext>Control group: Participants will receive usual nursing home care and no virtual reality intervention.Intervention group 1: Participants will receive solo virtual reality sports tourism using Meta Quest 3 head-mounted displays. The program will include 12 sessions over 4 weeks, three sessions per week. Each session will last 30–40 minutes, including 20–25 minutes of virtual reality exposure.Intervention group 2: Participants will receive group-based virtual reality sports tourism in groups of 3–5 residents using Meta Quest 3 head-mounted displays. The program will include 12 sessions over 4 weeks, three sessions per week, followed by a 5–10-minute group discussion after each session..</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 To protect confidentiality, privacy, and participants’ rights, names, personal identifiers, contact information, and any identifiable participant data will not be disclosed. All data will be coded and analyzed anonymously, and only aggregated study results will be reported.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Fraidniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Town. Raspina Tower. Block B</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۰۴۱۷۲۱۰۶۸۱۵</zip>
        <telephone>+98 936 387 5989</telephone>
        <email>hossein.faridniya@ut.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Faridniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Town. Raspina Tower. Block B</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۰۴۱۷۲۱۰۶۸۱۵</zip>
        <telephone>+98 936 387 5989</telephone>
        <email>hossein.faridniya@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants will be women aged 60 years or older who will be widowed; will have been living in a nursing home for at least three months; will be able to understand the study instructions and provide informed consent; will have adequate vision and hearing to use VR and complete the questionnaires; will be able to participate safely in seated VR sessions; and will be able to tolerate the VR familiarization session without marked discomfort.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>severe cognitive impairment; severe uncorrected visual or hearing impairment; a history of epilepsy or seizure disorder; severe vestibular problems or severe motion sickness; an unstable cardiovascular condition; severe psychiatric symptoms requiring immediate clinical care; concurrent participation in another structured psychosocial, behavioral, or medication-based intervention; or inability to tolerate the VR headset during the familiarization session because of marked dizziness, nausea, anxiety, or visual discomfort.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>0</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants will receive usual nursing home care and no virtual reality intervention.Intervention group 1: Participants will receive solo virtual reality sports tourism using Meta Quest 3 head-mounted displays. The program will include 12 sessions over 4 weeks, three sessions per week. Each session will last 30–40 minutes, including 20–25 minutes of virtual reality exposure.Intervention group 2: Participants will receive group-based virtual reality sports tourism in groups of 3–5 residents using Meta Quest 3 head-mounted displays. The program will include 12 sessions over 4 weeks, three sessions per week, followed by a 5–10-minute group discussion after each session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total loneliness score measured by the UCLA Loneliness Scale Version 3. Timepoint: At baseline, immediately after the 4-week intervention, and 30 days after the final intervention session. Method of measurement: Persian version of the UCLA Loneliness Scale Version 3, a 20-item questionnaire scored on a 4-point Likert 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name></contact_name>
        <contact_address>   </contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-03</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>Tehran – Ostad Motahari St. – Mir Emad St. – Fifth Alley – No. 3 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
