Relaxation and stress reduction through a virtual reality intervention
| ISRCTN | ISRCTN11162338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11162338 |
| Secondary identifying numbers | BMBF funding number: 16SV8068 |
- Submission date
- 22/01/2021
- Registration date
- 03/03/2021
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Stress is widespread in contemporary, Western societies and is a major source of disease. The study team has developed a virtual reality (VR) intervention for relaxation and stress reduction and will test how effective this is for stress reduction and relaxation against a freely chosen relaxation method.
Who can participate?
Participants aged 18 years and over with no current psychiatric disorder or cardiovascular disease
and no current intake of psychoactive or neuroactive drugs.
What does the study involve?
Study participants will be asked to complete a laboratory testing and three online surveys (two before the laboratory testing and one following the laboratory testing).
At the laboratory testing, participants will be subject to stress using the same method for each participant, and then a relaxation period with either the VR intervention or a freely chosen relaxation method. Participants receiving the VR intervention will be randomly chosen. The VR involves an image of a landscape with fields and trees. There will simultaneously be an image of a blue sphere that increases and decreases in size. This image will be accompanied by calming music, nature sounds, and general instruction to focus on breathing via headphones. Participants will be sat on a cantilever chair with a massage mat placed on its surface, and during the guided breathing, the pillow will vibrate in time with the instructions.
During laboratory testing, participant physical reactions (such as heart rate, breathing rate, and blood pressure) and emotional states will be assessed. The laboratory testing will involve measurements at the start of the session, when stress is introduced, when relaxation is introduced, and at the end of the session.
What are the possible benefits and risks of participating?
Possible benefits are stress reduction and relaxation during testing and a potential transfer of relaxation skills to real life.
A potential risk is that the stress test induces negative feelings and physiological arousal.
Where is the study run from?
Department of Clinical Psychology at the University of Siegen (Germany)
When is the study starting and how long is it expected to run for?
From July 2020 to October 2021
Who is funding the study?
This work is funded by the Bundesministerium für Bildung und Forschung (BMBF) (Germany)
Who is the main contact?
Miriam Kampa
miriam.kampa@uni-siegen.de
Contact information
Scientific
Adolf-Reichwein-Str. 2a
Siegen
57068
Germany
 ORCID ID |
0000-0001-8639-8547 |
|---|---|
| Phone | +49 641 99 26340 |
| miriam.kampa@uni-siegen.de |
Study information
| Study design | Single-center interventional randomized controlled trial with a 2 (condition) x 10 (time) factorial design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Facilitating relaxation and stress reduction through a virtual reality intervention: a randomized controlled trial |
| Study acronym | NoStress |
| Study objectives | Virtual reality (VR) reduces self-reported stress and increases self-reported relaxation and will demonstrate non-inferiority when compared to an active control group |
| Ethics approval(s) | Approved 17/09/2020, Universität Siegen, Rat für Ethik in der Forschung (Adolf-Reichwein-Str. 2a, 57076 Siegen, Germany; +49 271 740-4819; Katrin.Mayer@zv.uni-siegen.de), ref: ER_21/2020 "NoStress" |
| Health condition(s) or problem(s) studied | Stress and stress-related disorders |
| Intervention | Participants will be randomly assigned to either the treatment (virtual reality, VR) or the active control group (freely chosen relaxation method) according to an externally constructed randomization plan plan with a 1:1 ratio. A computerized simple randomization will be implemented to control for equal size of study groups. Research flow for treatment and control group will be as follows: 1. Recruitment 2. Online surveys 1 + 2 3. Laboratory testing 4. Online survey 3 in the evening of laboratory testing Participants will be blinded to the experimental group until relaxation. Laboratory testing will comprise a baseline measurement, a stress induction, the relaxation intervention, and a recovery measurement. A standardized protocol will be used for stress induction (MMST, Reinhardt et al., 2012). The multi-sensory VR includes visual, acoustic, and haptic features to increase the sense of presence. The VR shows a landscape with fields and trees; during the relaxation phase, sunrise is simulated. Via headphones calming music and nature sounds will be presented to the participants. During the relaxation phase, participants will be seated on a cantilever chair with a massage mat placed on its surface. As an intervention, a blue sphere depicts a pattern of respiration by increasing for inhalation and shrinking for exhalation to lower participants' respiratory rates. The intervention will further be supported by audio-guided instructions on relaxation and respiration (relaxing narrative) and a pillow vibrating synchronously to the increase in the size of the blue sphere. During laboratory testing, physiological parameters will be recorded and emotional states will repeatedly be assessed. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Stress ratings measured with a visual analogue scale (VAS) on a Likert scale ranging from 0 (not stressed) to 9 (very stressed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing 2. Relaxation ratings will be measured with a VAS on a Likert scale ranging from 0 (not relaxed) to 9 (very relaxed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing |
| Secondary outcome measures | 1. Heart rate variability measured with an electrocardiogram, analyzed using the Pan Tompkins algorithm, and estimated with the root mean square of successive differences (RMSSD) throughout baseline, stress, relaxation, and recovery 2. Tonic skin conductance level measured using galvanic skin conductance (GSR) recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 3. Number of phasic non-specific skin conductance responses measured using GSR recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 4 Systolic and diastolic blood pressure measured using an automated oscillometric blood pressure monitor at 1 min from the end of the baseline, stress, relaxation, and recovery phases 5. Respiratory rate measured using a respiration belt throughout baseline, stress, relaxation, and recovery 6. State mood measured using Der Mehrdimensionale Befindlichkeitsfragebogen (MDBF) questionnaire at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 7. State rumination measured using Der Response Styles Questionnaire (RSQ-D, adapted for state) at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 8. Post-event processing measured using Post-Event Processing Record (PEPR) questionnaire (translated to German) at post-relaxation and in the evening of the day of laboratory testing |
| Overall study start date | 01/07/2020 |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Aged ≥18 years |
| Key exclusion criteria | 1. Current psychiatric disorder or cardiovascular disease 2. Current intake of psychoactive or neuroactive drugs |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 20/05/2021 |
Locations
Countries of recruitment
- Germany
Study participating centre
Siegen
57068
Germany
Sponsor information
University/education
Adolf-Reichweinstr. 2a
Siegen
57068
Germany
| Phone | +49 271 740-4490 |
|---|---|
| tim.klucken@psychologie.uni-siegen.de | |
| Website | https://www.uni-siegen.de/start/index.html.en?lang=en |
"ROR" |
https://ror.org/02azyry73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the study protocol in Trials and planned publication of the study results in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available after the publication of study results upon request from the corresponding author (miriam.kampa@uni-siegen.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 09/05/2022 | 10/05/2022 | Yes | No | |
| Results article | 01/09/2023 | 17/11/2023 | Yes | No |
Editorial Notes
17/11/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
10/05/2022: Publication reference added.
23/06/2021: The recruitment end date has been changed from 15/10/2021 to 20/05/2021.
26/01/2021: Trial’s existence confirmed by Universität Siegen, Rat für Ethik in der Forschung.
