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.
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.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Mediant
Enschede
- Recruiting
Forte GGZ
Groningen
- Recruiting
Lentis
Groningen
- Recruiting
UMCG
Groningen
- Recruiting
Argo GGZ
Lochem
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 group | Role | What they receive |
|---|---|---|
| VRelax | Experimental | Participants will be using Virtual Reality relaxation (VRelax) in addition to treatment as usual Receives: Device: VRelax |
| Relaxation exercises | Active comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Usability of VRelax
The System Usability Scale (SUS) is being used to assess the usability of VRelax
Measured: Assessment at 6 weeks
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
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
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
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
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
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
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
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
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
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.
- First posted1 Jul 2022
- Study start23 Jun 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Catheleine van Driel, Principal investigator, University Medical Center GroningenWim Veling, Principal investigator, University Medical Center Groningen
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05440825
- Acronym / sponsor ID
- Relax XL / 202100662
- Conditions
- Virtual Reality
- Keywords
- virtual reality, relaxation, stress, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Twente, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRelax | Experimental | Device: VRelaxParticipants will be using Virtual Reality relaxation (VRelax) in addition to treatment as usual |
| Relaxation exercises | Active comparator | Other: Relaxation exercisesParticipants will be using relaxation exercises in addition to treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRelaxVirtual 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. | Device | VRelax |
| Relaxation exercisesRelaxation exercises consisting of audio-guided breathing exercises, muscle relaxation exercises, and body scan exercises | Other | Relaxation exercises |
Primary outcome
Change in Symptom Checklist Scale - 90 - R
Time frame: Between T0 and T1 (six weeks)
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.
25 secondary outcomes
Changes in burn-out symptoms and stress
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in anxiety
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in health and health-related quality of life
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in depression
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in self-reported depressive symptoms
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in mood
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in psychotic symptoms
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in psychosocial functioning
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in quality of life
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in recovery
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Changes in substance use
Time frame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
Change in sleep
Time frame: Assessment at 26 weeks and 52 weeks
Change in medical use, medical cost and productivity losses
Time frame: Assessment at 26 weeks and 52 weeks
Change in health-related quality of life
Time frame: Assessment at 26 weeks and 52 weeks
Usability of VRelax
Time frame: Assessment at 6 weeks
24 h ambulatory measurement of electrodermal activity, cardiovascular activity, and sleep
Time frame: The first and last week of using VRelax or relaxation exercises
Daily assessment of sleep
Time frame: The first and last week of using VRelax or relaxation exercises
Daily pre- and post-session assessments of calness and relaxation
Time frame: During the use of VRelax or relaxation exercises
Changes in electodermal activity in laboratory setting
Time frame: Assessment at baseline and six weeks
Changes in cardiovascular activity in laboratory setting
Time frame: Assessment at baseline and six weeks
Changes in physiological markers for comorbid somatic disease - weight
Time frame: Assessment at baseline and six weeks
Changes in physiological markers for comorbid somatic disease - height
Time frame: Assessment at baseline and six weeks
Changes in physiological markers for comorbid somatic disease - waist circumference
Time frame: Assessment at baseline and six weeks
Changes in physiological markers for comorbid somatic disease - blood pressure
Time frame: Assessment at baseline and six weeks
Changes in physiological markers for comorbid somatic disease - blood
Time frame: Assessment at baseline and six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 42406301Robbemond 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catheleine van Driel principal investigator
University Medical Center Groningen
Wim Veling principal investigator
University Medical Center Groningen
5 sites in 1 country: see every site and its status.
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.