VR Relaxation in Older Adults With Mental Illness

NCT06973941 | Completed

• 1 other identifier: 410522
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is exploring whether virtual reality (VR) can be a helpful and practical tool for reducing stress and anxiety in older adults receiving mental health care. The study compares two common relaxation methods: one using traditional guided imagery (a technique that uses calming mental pictures) and one using immersive VR technology. Participants are older adults with mental health conditions who take part in a single relaxation session using either VR or guided imagery. Before and after the session, researchers measure how relaxed, calm, and emotionally well the participants feel. The study aims to answer several questions: Do both methods reduce anxiety and negative emotions right after the session? Do they increase relaxation, well-being, and positive feelings? Is VR more effective than guided imagery for this group? Does feeling more immersed in the VR environment lead to lower anxiety? Researchers are also evaluating whether these techniques are comfortable and practical for older adults by looking at factors like satisfaction, drop-out rates, and ease of use. Because relaxation exercises are already used in older adult mental health care, this research could help improve how such techniques are delivered - especially if VR turns out to be a powerful, accessible option for this population.

Conditions

Mental Disorder

Keywords

relaxation; aging; virtual reality; mental health

Outcome Measures

Primary Outcomes (1)

• State anxiety

  Assessed using the German version of the state subscale of the State-Trait Anxiety Inventory (STAI-X1; Laux et al., 1981; Spielberger et al., 1970), which has good psychometric properties, such as a high internal consistency (α = .90) (Laux et al., 1981). The STAI-X1 is a self-report questionnaire comprising 20 items in total, some of which need to be reversed. Short statements, such as 'I am nervous.' (indicating presence of anxiety) or 'I feel calm' (indicating absence of anxiety), had to be evaluated on a 4-point scale ranging from 1 = 'not at all' to 4 = 'very much'. Patients are asked to indicate to what extent each statement applied to them at that moment. A sum score between 20 and 80 iscalculated, with higher values indicating a higher level of state anxiety.

  One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

Secondary Outcomes (9)

• Positive and negative affect

  One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

• Perceived stress

  One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

• Perceived relaxation

  One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

• Overall well-being

  One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.

• Drop out rates

  One measurement during a single session that takes 35-45 minutes.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Prior to the relaxation exercise, the patients receive a short training session on how to wear the VR headset, for which Oculus Meta Quest 2 (Reality Labs, Meta Platforms Inc) is used, and on how to navigate in the virtual world. Patients are informed that the investigator would stay in the room during the relaxation exercise but would not actively interact with them until the 10-minute intervention was over (except if they needed assistance or wished to stop). After the investigator starts the VR relaxation application, which is part of the app "Nature Treks VR" by Greenergames (released on May 21, 2019), the patients put on the headset and proceed with the relaxation exercise. The virtual world is a natural environment providing a view of a forest with a nearby river, mountains in the distance, flowers and animals, accompanied by relaxing music and the sound of birds chirping. All patients experience the same relaxing environment.

Other: Virtual reality relaxation

Guided Imagery

ACTIVE COMPARATOR

Patients receive an audio guided dream journey, conducted by one of the investigators. The dream journey is exclusively developed for the purpose of this study by an experienced psychiatrist to ensure comparability and to control for familiarity, since this type of relaxation exercise is implemented in regular geriatric psychiatric care. Duration (10 minutes in total) and content (forest, natural environment) of the GI-based dream journey are tailored as precisely as possible to the relaxing VR application. Thus, the dream journey describes a similar natural scene taking place in a forest with a river, flowers and animals in the surrounding area and mountains in the distance, accompanied by relaxing music and nature sounds. We ensure to only include specific elements, e.g. deers and rabbits, that are also visible in the VR environment and avoid any additional instructions not provided in the VR application.

Other: Guided imagery relaxation

Interventions

Virtual reality relaxation OTHER

10-minute VR relaxation application, part of the app "Nature Treks VR" by Greenergames (released on May 21, 2019), used with a Metaquest head-mounted display

Virtual Reality

Guided imagery relaxation OTHER

10-minute guided imagery relaxation where an investigator reads a dream journey

Guided Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• in psychiatric treatment at the St. Hedwig Hospital Berlin, Germany
• a psychiatric diagnosis (according to ICD-10)
• aged 55 years and older
• ability to understand the content of the study and provide written informed consent

You may not qualify if:

• insufficient proficiency in German language
• acute aggression
• acute suicidality

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 15, 2025
• Study Start: November 13, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)