RecruitingNot ApplicableNCT05440825

Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation

Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation for People with Burn-out, Mood, Anxiety or Psychotic Disorders: a Single-blind Randomized Controlled Trial


Sponsor

University Medical Center Groningen

Enrollment

171 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Stress is a well-established factor in the onset and continuation of burn-out anxiety, mood and psychotic disorders. Furthermore, sleep disturbances predispose and exacerbate mental health symptoms of the condition. In people with mental health problems, higher (social) stress-reactivity and impaired stress-recovery are present which is further aggravated by sleep disturbances and sleep deprivation. Relaxation reduces the stress, which in turn may reduce mental health symptoms, improve daily life functioning and quality of life. The burden of burn-out and psychiatric illness can be decreased by stress-reducing interventions which have been shown to improve quality of life and social and occupational functioning. Although current stress-reducing interventions appear to be efficacious, it must be taken into account that they require mental effort (i.e. attention and concentration of patients) which is often impaired in patients. To bridge this gap, a new e-Health application was developed called VRelax. VRelax is a virtual reality self-management stress-reduction tool (VRelax). This tool requires far less effort than traditional relaxation exercises due to its immersive properties, and has an immediate effect on perceived stress and emotional mental states. In this study, the short-, medium- and long term effect of VRelax + treatment as usual (TAU) compared to TAU and relaxation exercises on symptomatic recovery, level of social functioning, healthcare consumption and societal costs will be investigated.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether virtual reality (VR) relaxation exercises can help people who are already in mental health treatment manage stress and sleep problems better. **You may be eligible if...** - You are over 18 years old - You are currently receiving treatment for burnout, anxiety, bipolar disorder, PTSD, depression, or a psychotic disorder - You are experiencing stress and/or sleep disturbances **You may NOT be eligible if...** - You have a substance use disorder (drug or alcohol addiction) - You have photosensitive epilepsy with a seizure in the past year, or have organic brain damage - You do not have sufficient command of the Dutch language - You have an intellectual disability (estimated IQ below 70) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVRelax

Virtual Relaxation relaxation, VRelax, includes a collection of high quality 360° degrees videos of nature environments with 3D audio and interactive elements, created for relaxation, stress-reduction and improving sleep. When activated, the participant can choose specific 360° videos from a menu. The 360° videos include among other things a coral reef with an interactive game element of popping air bubbles, a scuba diving experience with dolphins, a mountain meadow with cows, and a session of Tibetan sound bowls.

OTHERRelaxation exercises

Relaxation exercises consisting of audio-guided breathing exercises, muscle relaxation exercises, and body scan exercises


Locations(5)

Mediant

Enschede, Netherlands

Forte GGZ

Groningen, Netherlands

Lentis

Groningen, Netherlands

UMCG

Groningen, Netherlands

Argo GGZ

Lochem, Netherlands

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NCT05440825


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