NCT07712549

Brief Summary

Prolonged hospitalization can reduce opportunities for independent activity, choice, and control and may contribute to passivity, low mood, anxiety, and distress in some older adults. Zenctuary VR+ is a seated, nature-based virtual reality program that combines calming environments with simple, low-demand activities. The active program allows participants to make choices, move between predefined locations, and influence elements of the virtual environment. Trained staff supervise every session and provide support when needed. The trial evaluates whether the interactive version of Zenctuary VR+ reduces psychological distress more than passive exposure to the same virtual environments. A total of 100 hospitalized adults aged 60 years or older will be randomly assigned to the interactive VR condition or the passive VR condition. Eligible participants are expected to remain hospitalized for at least four weeks following enrolment. Both groups will receive six sessions over three weeks. Psychological distress and related psychological factors will be assessed before the first session, immediately after the three-week intervention period, and four weeks after the final session.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Nov 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 14, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Virtual realityRandomized controlled trialDigital health interventionNature exposureSelf-efficacyOlder adultsLearned helplessnessPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale Total Score

    The Hospital Anxiety and Depression Scale is a 14-item self-report measure comprising seven anxiety items and seven depression items. The total score ranges from 0 to 42, with higher scores indicating greater psychological distress.

    Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session

Secondary Outcomes (4)

  • Change From Baseline in Self-Esteem as Measured by the Rosenberg Self-Esteem Scale

    Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session

  • Change From Baseline in General Self-Efficacy as Measured by the General Self-Efficacy Scale

    Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session

  • Change From Baseline in Depressive Symptoms as Measured by the Geriatric Depression Scale

    Baseline and immediately after completion of the three-week intervention period

  • Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale

    Baseline and immediately after completion of the three-week intervention period

Other Outcomes (4)

  • Change From Baseline in Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale Anxiety Subscale

    Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session

  • Change From Baseline in Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale Depression Subscale

    Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session

  • Change From Baseline in Learned Helplessness as Measured by the Learned Helplessness Scale

    Baseline and immediately after completion of the three-week intervention period

  • +1 more other outcomes

Study Arms (2)

Active Zenctuary VR+ Intervention

EXPERIMENTAL

Participants receive six sessions of the interactive, nature-based Zenctuary VR+ program over three weeks (twice weekly), delivered via head-mounted display (Meta Quest 3). The intervention includes low cognitive load interactive tasks (simple choices, navigation between virtual locations, and environmental interaction) designed to support agency, perceived control, and successful action while participants remain seated and supported by trained personnel.

Device: Interactive nature-based virtual reality intervention

Passive VR Control

ACTIVE COMPARATOR

Participants are exposed to the same nature-based virtual environments and head-mounted display (Meta Quest 3) as the active arm, following the same six-session, three-week schedule, but without interactive elements. Participants passively observe the virtual scenery, controlling for VR exposure and nature content while isolating the added effect of interactivity and agency-supporting features.

Device: Passive nature-based virtual reality exposure

Interventions

An immersive, head-mounted-display-delivered virtual reality experience presenting the same nature-based virtual environments as the active intervention, without interactive elements. Participants passively observe the virtual scenery while seated, with no opportunity for choice, navigation, or environmental interaction. Delivered in six sessions over three weeks (twice weekly), matching the active intervention in schedule, apparatus, and visual content, differing only in the absence of interactivity.

Passive VR Control

An immersive, head-mounted-display-delivered virtual reality intervention presenting nature-based virtual environments with interactive, low cognitive load tasks. Participants make simple choices, navigate between virtual locations, and influence elements of the environment while seated, with the goal of supporting agency, perceived control, and successful action. Delivered in six sessions over three weeks (twice weekly), each guided by a trained operator using a standardized least-assistance approach.

Active Zenctuary VR+ Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 years or older
  • Diagnosed with at least one chronic medical condition
  • Currently receiving inpatient hospital care
  • Expected to remain hospitalized for at least four weeks following enrolment
  • Physically able to use a head-mounted virtual reality device, as determined by the treating clinical team
  • Able to provide written informed consent
  • Able to complete study assessments and participate in the intervention procedures

You may not qualify if:

  • Cognitive impairment, defined as a score below 18 on the Montreal Cognitive Assessment (MoCA)
  • Impaired consciousness or reduced alertness that would prevent meaningful participation
  • Current or previous diagnosis of a psychotic disorder
  • Current substance use disorder that would interfere with participation in the study procedures
  • Current treatment with antipsychotic medication
  • Untreated epilepsy
  • Severe vestibular dysfunction or recurrent vertigo
  • Any medical condition judged by the treating physician to make participation unsafe or inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Geriatric Care and Nursing Science (Semmelweis University)

Budapest, 1097, Hungary

Location

Rehabilitation Clinic (Semmelweis University)

Budapest, 1121, Hungary

Location

Department of Neurosurgery (University of Szeged)

Szeged, 6725, Hungary

Location

Related Links

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ágnes Bakk, PhD

    Moholy-Nagy University of Art and Design

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pál Tamás Szabó, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations