Clinical trial NCT06973941: VR Relaxation in Older Adults With Mental Illness
Official title: Effectiveness and Feasibility of Virtual Reality Relaxation Compared to Guided Imagery Relaxation in Older Adults With Mental Illness: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: relaxation
aging
virtual reality
mental health
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This single-blinded pilot randomized controlled trial investigates the effectiveness and feasibility of virtual reality (VR)-based relaxation compared to guided imagery (GI)-based relaxation among older adults receiving inpatient psychiatric care. The study targets geriatric patients with various mental health diagnoses to evaluate whether immersive VR experiences offer comparable or superior benefits to a traditional guided imagery intervention.

The primary objectives are to determine whether:

Both interventions lead to an immediate reduction in state anxiety, negative affect, and perceived stress.

Both interventions result in an immediate increase in well-being, positive affect, and perceived relaxation.

Participants in the VR group show greater improvements in psychological outcomes than those in the GI group.

In the VR group, a higher sense of presence predicts lower post-intervention state anxiety (the primary outcome).

Feasibility is assessed based on participant retention, self-reported satisfaction, overall experience, and-specifically for the VR group-motion sickness and sense of presence. The study hypothesizes that both interventions are feasible for this patient population, with minimal side effects and no significant influence of medical or sociodemographic factors on feasibility outcomes.

Design and Randomization:

Participants are randomly assigned in a 1:1 ratio to either the VR or GI condition using block randomization with a block size of four. Randomization is conducted using R Studio (version 4.4.2), ensuring balanced group allocation throughout the study. This method helps mitigate the impact of clinical setting variables, such as unplanned discharges, on group sizes.

Participant Procedures:

Following informed consent, each participant receives detailed information about the study, including its purpose, duration, and the voluntary nature of participation. Baseline data (T0) are collected via structured interviews and digital self-report questionnaires administered through REDCap on a tablet. If necessary, the investigator reads the questions aloud and records responses.

VR Group:

Participants allocated to the VR group complete a brief training on using the Oculus Meta Quest 2 headset. The intervention consists of a 10-minute immersive experience using the "Nature Treks VR" application, which features a calming natural environment with a forest, river, distant mountains, flowers, animals, and ambient nature sounds. All participants in this group view the same virtual environment to maintain standardization. The investigator remains in the room to offer assistance if needed but does not interact during the session unless requested.

GI Group:

Participants in the GI group listen to a 10-minute guided dream journey, designed specifically for this study by a psychiatrist. The audio script mirrors the VR environment, describing a peaceful forest scene with similar natural elements (e.g., deer, rabbits, river, mountains), accompanied by matching music and sounds. The script avoids additional guidance such as breathing cues to ensure comparability with the VR experience.

Post-Intervention Procedures:

Immediately after the session, participants in the VR group rate their experience of motion sickness. All participants then complete the post-intervention questionnaires (T1), consistent with their assigned condition. The full procedure lasts approximately 45 minutes for the VR group and 35 minutes for the GI group.

Outcomes:

Effectiveness is assessed at T0 and T1 using the State-Trait Anxiety Inventory, the Positive and Negative Affect Schedule, and Visual Analog Scales. Dropout rates, satisfaction and experience are compared. Motion sickness and sense of presence are measured with the Fast Motion Sickness Scale and the Igroup Presence Questionnaire.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: State anxiety
timeFrame: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.
Secondary outcomes:
measure: Positive and negative affect
timeFrame: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Perceived stress
timeFrame: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Perceived relaxation
timeFrame: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Overall well-being
timeFrame: One pre- and post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Drop out rates
timeFrame: One measurement during a single session that takes 35-45 minutes.
measure: Patients' satisfaction
timeFrame: One post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Patients' experience
timeFrame: One post-intervention-measurement during a single session that takes 35-45 minutes.
measure: Motion Sickness
timeFrame: One post-intervention-measurement during a single VR session that takes 35-45 minutes.
measure: Sense of presence
timeFrame: One post-intervention-measurement during a single VR session that takes 35-45 minutes.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
References: