AzTrials
AzTrials

Virtual RealityRelax XLNCT05440825

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

A study testing VRelax and Relaxation exercises in people with Virtual Reality, run by University Medical Center Groningen at 5 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Virtual Reality
What is being tested?
VRelax and Relaxation exercises
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
5 sitesNetherlands
Study dates
23 Jun 2022to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently receiving treatment for burn-out, anxiety disorder, bipolar disorder, post-traumatic stress disorder, depressive disorder and/or psychotic disorder.
  • Complaints of stress and/or sleep disturbances as reported by patient or therapist
  • Age > 18

Who cannot join

  • Individuals with a DSM-5 classification of substance use disorder
  • Individuals with photosensitive epilepsy with seizure in the past year or organic brain damage
  • Individuals with insufficient command of Dutch language
  • Individuals with intellectual disability (estimated IQ < 70)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lisanne Robbemond, MSc contact

+315036114367

l.m.robbemond@umcg.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting
  • Mediant

    Enschede

    Recruiting
  • Forte GGZ

    Groningen

    Recruiting
  • Lentis

    Groningen

    Recruiting
  • UMCG

    Groningen

    Recruiting
  • Argo GGZ

    Lochem

    Recruiting

Other trials in Netherlands

About this study

Official title: 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

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.

Read the detailed description

Once participants consent, they will complete the first assessment (T0). T0 starts with a physical assessment that consist of measuring weight, height, and waist circumference, a blood pressure test and a blood test. Furthermore, they will complete an assessment of physiological parameters during the use of VRelax. Then participants will complete a couple demographic questions, the Symptom Checklist-90-revised (SCL-90-R), the WHO Disability Assessment Schedule (WHO-DAS), the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), the Hamilton Rating Scale for Depression (HRSD), and the Psychotic Symptom Rating Scales (Psyrats). Participants will then be informed to wear to different wearables for two weeks (Empatica E4 and MotionWatch 8). The instruction is to wear the Empatica E4 during the day to measure their Heart Rate (HR), Heart Rate Variability (HRV), and Skin Conductance (SC). The MotionWatch 8 will be worn during the night to measure their sleep. Participants also receive the instruction to complete the following online questionnaires at home: Burn-out Assessment Tool (BAT), Beck Anxiety Inventory (BAI), Inventory of Depressive Symptomatology Self Reported (IDS-SR), Mood Disorder Questionnaire (MDQ), Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), Manchester Short Assessment of Quality of Life (MANSA), Recovery Assessment Scale - domains and stages (RAS-DS), Treatment Inventory of Costs in Patients (TiC-P), 36-item Short Form Survey (SF-36), and EQ-5D-5L.

Participants receive from their healthcare professional either VRelax or relaxation exercises with the instruction to use this for at least 20 minutes a day, at least five days a week, for six weeks. During those six weeks, participants will wear the wearables (Empatica E4 and MotionWatch 8) the first and the last week.

After six weeks after the first assessment, participants will complete the second assessment (T1). T1 is identical to T0 plus the System Usability Scale (SUS) for the participants who used VRelax. After 26 weeks after the first assessment, participants will complete the third assessment (T2). T2 consists of SCL-90-R, WHO-DAS, ASSIST, HRSD, Psyrats, BAT, BAI, IDS-SR, MDQ, PSS, PSQI, MANSA, TiC-P, SF-36, and EQ-5D-5L. The fourth and final assessment (T3) is 52 weeks after the first assessment. T3 is identical to T2.

Conditions
Virtual Reality
Being tested
VRelax, Relaxation exercises
Keywords
virtual reality, relaxation, stress, sleep

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRelaxDevice

    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.

  • Relaxation exercisesOther

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

Study groups in NCT05440825
Study groupRoleWhat they receive
VRelaxExperimentalParticipants will be using Virtual Reality relaxation (VRelax) in addition to treatment as usual
Receives: Device: VRelax
Relaxation exercisesActive comparatorParticipants will be using relaxation exercises in addition to treatment as usual
Receives: Other: Relaxation exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Symptom Checklist Scale - 90 - R

    The SCL-90-R is used to evaluate a broad range of psychological problems and symptoms of psychopathology during the last week.The SCL-90-R consists of 90 items scored on a five-point Likert scale.

    Measured: Between T0 and T1 (six weeks)

Secondary outcomes (25)
  1. Changes in burn-out symptoms and stress

    The BAT is being used to evaluate the changes in burn-out symptoms and the PSS is being used to evaluate the changes in perceived stress. Both questionnaires have a five-point scale ranging from "never" to "always"

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  2. Changes in anxiety

    The BAI is is a self-report measure of anxiety. Each answer is being scored on a scale value of 0 (not at all) to 3 (severly). A higher total score indicate more severe anxiety

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  3. Changes in health and health-related quality of life

    The EQ-5D-5L is tool to measure health and health-related quality of life. The first 25 items of this questionnaires are based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The patient is asked to indicate their health status by choosing the most appropriate level: no problems, slight problems, moderate problems, severe problems, and extreme problems. The last question is to indicate their current health status on a scale from 0 to 100.

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  4. Changes in depression

    The HRSD is a structured interview to assess the severity of depression. The HRSD contains 17 items pertaining to symptoms of depression experienced over the past week. The instruction for the researcher is to select the most appropriate answer which charaterizes the participant the best, ranging from "absent" to clearly present.

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  5. Changes in self-reported depressive symptoms

    The IDS-SR is a 3-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3.

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  6. Changes in mood

    The MDQ is standard a 13-item self-report screening questionnaire with two optional questions that assesses symptoms of mania, hypomania, and depression. Participants check the "yes" or "no" boxes in response to answer. The second optional questions pertains to the level of functional impairment and has four answer options: no problem, minor problem, moderate problem, serious problem

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  7. Changes in psychotic symptoms

    The psyrats is a semi-structured interview to assess characteristics of hallucinations and delusions. The auditory hallucinations subscale (AHS) has 11 items. The delucions subscale (DS) has six items

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  8. Changes in psychosocial functioning

    The WHO-DAS II is an interview-administered 36-item questionnaire that covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, participation. The participant is asked to indicate difficulties by selecting the most appropriate level: none, mild, moderate, severe, extreme or cannot do. In addition, the participant is asked on how many days these difficulties were present in the last 30 days: one day, less than a week, less than two weeks, more than two weeks, all days

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  9. Changes in quality of life

    The MANSA is a 16-item questionnaire to assess the quality of life. Satisfaction is rated on 7-point rating scale (1 = negative extreme, 7 = positive extreme)

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  10. Changes in recovery

    The Recovery Assessment Scale - Domains and Stages (RAS-DS) is a 38-item questionnaire to measure participants perceptions of individual recovery that they rate on a four-point scale: "untrue", "a bit untrue", "mostly true", "completely true"

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  11. Changes in substance use

    The ASSIST is an 8-item interview that measures an participant's use of alcohol, tabacco products, and other drugss across his/her lifetime and in the past three months. The first item requires a "yes" or "no" answer while item 2 - 8 are scored on a five-point scale: never, once or twice, monthly, weekly, daily or almost daily

    Measured: Assessment at baseline, six weeks, 26 weeks, and 52 weeks

  12. Change in sleep

    The PSQI is a 19-item questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each item is rated on a four-point scale: never, less than once a week, 1 - 2 times a week, 3 or more times a week

    Measured: Assessment at 26 weeks and 52 weeks

  13. Change in medical use, medical cost and productivity losses

    The TiC-P is a self-report questionnaire that consists of two parts. The first part includes 38 structured questions, starting with yes/no questions and followed by a question on the volume of medical consumption. The second part deals with questions about work.

    Measured: Assessment at 26 weeks and 52 weeks

  14. Change in health-related quality of life

    The SF-36 is a 36-item self-report questionnaire and measures eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Items are scored on different scales: yes/no scale, three-point scale, and five-point scale

    Measured: Assessment at 26 weeks and 52 weeks

  15. Usability of VRelax

    The System Usability Scale (SUS) is being used to assess the usability of VRelax

    Measured: Assessment at 6 weeks

  16. 24 h ambulatory measurement of electrodermal activity, cardiovascular activity, and sleep

    The MotionWatch 8 provides data on sleep (i.e. sleep latency, total sleep time, wake after sleep onset, sleep efficiency). The Empatica E4 provides data on electrodermal activity (Skin Conductance Level (SCL), number of Skin Conductance Responses (SCRs), Amplitude of the Skin conductance responses (S-AMPL)) and cardiovascular activity, time domain (mean RR interval, root mean square of successive differences between normal heartbeats (RMSSD), standard deviation of the normal sinus beats (SDNN))

    Measured: The first and last week of using VRelax or relaxation exercises

  17. Daily assessment of sleep

    A basic sleep diary that consist of questions about time of going to bed, time of falling asleep, time of waking up, and time of getting up

    Measured: The first and last week of using VRelax or relaxation exercises

  18. Daily pre- and post-session assessments of calness and relaxation

    Within the VRelax environment, participants rate their level of calmness and relaxation with VAS items before and after each session. The group that is using the relaxation exercises, there is an online questionnaire to rate their pre- and post-session level of calmness and relaxation after using the relaxation exercises.

    Measured: During the use of VRelax or relaxation exercises

  19. Changes in electodermal activity in laboratory setting

    The Shimmer 3 is being used to evaluate the electrodermal activity during the use of VRelax in laboratory setting

    Measured: Assessment at baseline and six weeks

  20. Changes in cardiovascular activity in laboratory setting

    The Shimmer 3 is being used to evaluate the cardiovascular activity during the use of VRelax in laboratory setting

    Measured: Assessment at baseline and six weeks

  21. Changes in physiological markers for comorbid somatic disease - weight

    A scale is being used to evaluate changes in weight

    Measured: Assessment at baseline and six weeks

  22. Changes in physiological markers for comorbid somatic disease - height

    A measurement tape is being used to evaluate changes in height

    Measured: Assessment at baseline and six weeks

  23. Changes in physiological markers for comorbid somatic disease - waist circumference

    A measurement tape is being used to evaluate changes in waist circumference

    Measured: Assessment at baseline and six weeks

  24. Changes in physiological markers for comorbid somatic disease - blood pressure

    A blood pressure monitor is being used to evaluate changes in blood pressure

    Measured: Assessment at baseline and six weeks

  25. Changes in physiological markers for comorbid somatic disease - blood

    Blood is being drawn to evaluate the changes in HBA1c, glucose, TC, HDL-C, TC-HDC-ratio, LDL-c, triglyceriden, creatinine (eGFR)

    Measured: Assessment at baseline and six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start23 Jun 2022
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
171 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05440825
Sponsor's protocol ID
202100662
Acronym
Relax XL
Status last verified
Mar 2025
First submitted
17 Jun 2022
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Robbemond LM, van Driel CMG, Scholten N, Veling W, Noordzij ML. The Impact of Self-Managed Virtual Reality Relaxation on Non-invasive Ambulatory Physiological Markers in Home-Based Psychiatric Care. Appl Psychophysiol Biofeedback. 2026 Jul 6. doi: 10.1007/s10484-026-09796-4. Online ahead of print.

    PubMed 42406301

Questions about this trial

What is this clinical trial studying?

A study testing VRelax and Relaxation exercises in people with Virtual Reality, run by University Medical Center Groningen at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisanne Robbemond, MSc (+315036114367, l.m.robbemond@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Symptom Checklist Scale - 90 - R (time frame: Between T0 and T1 (six weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05440825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in