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Solo versus Group-Based Virtual Reality Sports Tourism for Reducing Loneliness in Widowed Older Women

Protocol summary

Study aim
To examine the effects of solo and group-based virtual reality sports tourism on loneliness among widowed older women living in nursing homes, and to compare whether the group-based format produces greater reductions in loneliness than the solo format and usual care.
Design
Three-arm parallel randomized controlled trial with a 1:1:1 allocation ratio and assessments at baseline, post-intervention, and 30-day follow-up.
Settings and conduct
The study will be conducted in nursing homes in Tehran, Iran. Eligible participants will be screened, familiarized with virtual reality, randomized into three groups, and assessed at baseline, post-intervention, and 30-day follow-up.
Participants/Inclusion and exclusion criteria
Widowed women aged 60 years or older who will have been living in nursing homes for at least three months will be eligible if they will be able to provide informed consent, use virtual reality safely, complete the questionnaires, and tolerate the virtual reality familiarization session. Exclusion criteria will include severe cognitive, sensory, vestibular, neurological, cardiovascular, or psychiatric conditions, a history of epilepsy or seizure disorder, severe motion sickness, concurrent participation in structured interventions, or marked intolerance to virtual reality.
Intervention groups
Control group: Usual nursing home care, with no VR-based intervention. Solo VR group: Individual VR sports tourism using Meta Quest 3, delivered in 12 sessions over 4 weeks, three sessions per week. Group-based VR group: VR sports tourism in small groups of 3–5 residents using Meta Quest 3, delivered in 12 sessions over 4 weeks, with a brief post-session group discussion.
Main outcome variables
Loneliness will be measured using the UCLA Loneliness Scale Version 3.

General information

Reason for update
Acronym
VRST
IRCT registration information
IRCT registration number: IRCT20260623069931N1
Registration date: 2026-07-19, 1405/04/28
Registration timing: prospective

Last update: 2026-07-19, 1405/04/28
Update count: 0
Registration date
2026-07-19, 1405/04/28
Registrant information
Name
Hossein Faridniya
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 936 387 5989
Email address
hossein.faridniya@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-24, 1405/05/02
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Solo versus Group-Based Virtual Reality Sports Tourism for Reducing Loneliness in Widowed Older Women
Public title
Virtual Reality Sports Tourism
Purpose
Supportive
Inclusion/Exclusion 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.
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.
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 115
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Approval date
empty
Ethics committee reference number

2

Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
Tehran – Ostad Motahari St. – Mir Emad St. – Fifth Alley – No. 3
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-05-03, 1404/02/13
Ethics committee reference number
IR.SSRC.REC.1404.029

Health conditions studied

1

Description of health condition studied
Loneliness among widowed older women living in nursing homes
ICD-10 code
0
ICD-10 code description
0

Primary outcomes

1

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranmehr Elderly Care Home
Full name of responsible person
Sajjad mohamadyari
Street address
No. 6, Farvardin Alley, 10th Street, South Piroozan Street, Hormozan, Shahrak-e Gharb, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein faridniya
Street address
Tehran – Ostad Motahari St. – Mir Emad St. – Fifth Alley – No. 3
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 901 729 7853
Email
hossein.faridniya@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Fraidniya
Position
Researcher- phd candidate
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Beheshti Town. Raspina Tower. Block B
City
Tehran
Province
Tehran
Postal code
۵۰۴۱۷۲۱۰۶۸۱۵
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Hossein Faridniya
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Beheshti Town. Raspina Tower. Block B
City
Tehran
Province
Tehran
Postal code
۵۰۴۱۷۲۱۰۶۸۱۵
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hossein faridniya
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Beheshti Town. Raspina Tower. Block B
City
Tehran
Province
Tehran
Postal code
۵۰۴۲۷۲۱۰۶۸۱۵
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified individual participant data, including group allocation, demographic variables, loneliness scores measured by the UCLA Loneliness Scale Version 3 at baseline, post-intervention, and 30-day follow-up, and adherence/safety information. No names, contact details, or personally identifiable information will be shared.
When the data will become available and for how long
De-identified participant data will be available from 6 months after publication of the main study results and will remain available for 5 years. Access will be provided only for scientific purposes upon reasonable request to the corresponding author and subject to ethical and confidentiality requirements.
To whom data/document is available
Qualified researchers affiliated with academic, scientific, or healthcare institutions may request access for legitimate scientific purposes, subject to ethical approval, confidentiality requirements, and approval by the corresponding author.
Under which criteria data/document could be used
Data may be used only for non-commercial scientific purposes, including verification of published results, secondary analysis, systematic reviews, or meta-analyses. Requests must include a clear research proposal, ethics approval or exemption when applicable, and a commitment to confidentiality. Data must not be used to identify participants, shared with unauthorized parties, or used for purposes outside the approved request.
From where data/document is obtainable
Requests for access to data or documents should be sent to the corresponding author: Hossein Faridniya. Email: Hossein.faridniya@ut.ac.ir
What processes are involved for a request to access data/document
Requests will be reviewed by the corresponding author within 4 weeks. Applicants must submit a written request including the study purpose, planned analyses, institutional affiliation, and ethics approval or exemption when applicable. Approved applicants will be required to sign a confidentiality and data-use agreement before receiving the de-identified data or documents.
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