To develop a second VRelax prototype for reducing impact of stress and test it in patients with depressive, bipolar, anxiety and psychotic disorders. User experiences and immediate effects on subjective stress and arousal will be investigated and…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes: momentary subjective stress, user experiences.
Secondary outcome
Secondary outcomes: perceived stress, psychiatric symptoms, use of
benzodiazepines and psychoactive substances.
Background summary
Patients with psychiatric disorders often have an increased level of stress,
which makes it more difficult to recover from their symptoms. Relaxation
exercises, involving imaginary visualization of pleasant environments, can have
a positive effect on the level of tension and arousal, but are often difficult
to perform for people with psychiatric symptoms. Virtual Reality (VR) may help
to relax. We previously conducted a feasibility pilot study with a first VR
relaxation prototype. This second pilot study examines whether VR 360o films
(VRelax) can help patients with current psychiatric symptoms to reduce level of
subjective stress.
Study objective
To develop a second VRelax prototype for reducing impact of stress and test it
in patients with depressive, bipolar, anxiety and psychotic disorders. User
experiences and immediate effects on subjective stress and arousal will be
investigated and compared to standard relaxation exercises.
Study design
This pilot study is a randomized cross-over trial with two relaxation tools: 1)
the VRelax relaxation app and 2) standard relaxation exercises. Participants
will use both tools consecutively for 10 days at home. Participants will be
randomly assigned to order of the interventions.
Intervention
- VRelax: the tool is used with a smartphone that is connected to a head
mounted display. When activated, the participant is on a beach, from which
he/she can choose where to go. The 360o videos of relaxing environments include
a variety of nature landscapes. Interactive elements and relaxation exercises
are embedded in the environments. Participants navigate through the
environments by looking at hotspots.
- Standard relaxation exercises: 2D nature videos and audio tracks with guided
meditation / progressive muscle relaxation.
Participants can use the interventions as much as they like, but minimally once
daily for at least 10 minutes. Before and after each session, momentary
subjective stress is measured with Visual Analogue Scales.
Study burden and risks
Pre and post-intervention assessments include questionnaires and a qualitative
interview about user experiences, with an average total duration of 3x120
minutes. Interventions take minimally 200 minutes at home. We expect patients
to benefit from the intervention by primary reduced level of stress and
secondary less psychiatric symptoms. Some patients may experience mild cyber
sickness during the VR video, i.e. transient nausea or dizziness. No major
adverse events are expected or have been documented.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Currently receiving ambulatory treatment for DSM-5 depressive disorder, bipolar disorder, anxiety disorder or psychotic disorder
• At least moderate level of perceived stress, based on self-report or clinician report
• Age >18
Exclusion criteria
• DSM-5 diagnosis of substance use disorder
• Benzodiazepine use > 10 mg / day diazepam equivalent
• Diagnosis of epilepsy or organic brain damage
• Insufficient command of Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL64380.042.17 |
OMON | NL-OMON21150 |