Feasibility study on virtual reality for patients with chronic pain
Organizational Data
- DRKS-ID:
- DRKS00032471
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2023-08-15
- Last update in DRKS:
- 2023-08-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
A look at current research in medicine shows that approaches from the field of virtual reality (VR) are emerging and attracting increasing attention. A current literature search resulted in over 5000 hits in Medline on "virtual reality" in the publication titles. VR means that users are immersed in an artificially animated world via screens or special glasses. For example, an impressive landscape such as a beautiful beach or a mountain landscape can be explored virtually. In some fantasy worlds, it is also possible to actively interact with the environment by collecting objects or working on objects (e.g. catching balls, cutting up fruit), similar to a computer game. A realistic design of the virtual landscapes enables the user to fully immerse him/herself in these worlds, i.e. to experience an "immersion" (Lindner et al., 2020). In addition to the use of this technology, for example during operations (Gendia et al., 2023), VR is also already being used successfully to treat acute pain (Lindner et al., 2020). For example, the game "SnowWorld" was one of the first VR applications to be used in wound care for patients with burn injuries. While patients were undergoing painful dressing changes in the clinic, they were able to fight snowmen and other creatures in a virtual ice landscape, and were highly distracted from their pain (Hoffman et al., 2011). Further research suggests that VR can also be an effective method of pain reduction in the treatment of chronic pain. The research group led by Bernard M. Garrett from the University of British Columbia in Canada, for example, tested various VR applications for home use in patients with chronic pain, which they were asked to practice daily for four weeks. The VR applications consisted of a meditative walk in the woods, a flight over a flower meadow, various 3D puzzle games and a science fiction computer game on an alien planet. The results showed that some of the patients were very fond of the VR technology and praised its distracting character (Garrett et al., 2020). Distraction, along with exposure and neuromodulation, is being discussed as one of the potential efficacy factors of VR for chronic pain. Distraction is already known as a successful mechanism in the therapy of chronic pain (Lindner et al., 2020). The therapy of chronic pain has a high socio-political relevance. On the one hand, this is due to the high prevalence figures: more than ¼ of the total German population is affected by chronic pain. On the other hand, high treatment costs and also high periods of incapacity to work are a consequence of these high prevalences, which burden our economy and society (Kieselbach et al., 2021; Häuser et al., 2014). Chronic pain is nowadays successfully treated with interdisciplinary multimodal pain therapy. However, there is also a constant need for improvement and embedding of future-oriented technologies. VR offers the great advantage of being non-invasive and being able to be embedded in existing multimodal, interdisciplinary pain therapies (Lindner et al., 2020). As the study by Garrett (2020) shows, there is also the opportunity to use VR at home, for example in outpatient measures or in prevention or aftercare. In addition to in-depth research on the modes of action and therapeutic effects of VR in chronic pain, individual research on acceptance, side effects and contraindications in chronic pain patients is also needed. For example, the study by Garrett described above showed that some patients were not very comfortable with the technology. Some of the tasks to be mastered were even perceived as more conducive to pain in this group due to their difficulty. Difficulties with the use of technology and cases of cyber-sickness were reported (Garrett et al., 2020). Dizziness, nausea or headaches are possible symptoms described in this phenomenon, which may result from irritation of the vestibular system by the illusion of VR. The Simulator Sickness Questionnaire (SSQ) is a questionnaire that can be used to identify this phenomenon (Lindner et al. 2020; Kennedy 1993). Garrett BM, Tao G, Taverner T et al. (2020). Patients perceptions of virtual reality therapy in the management of chronic cancer pain. Heliyon, 6(5), e03916. https://doi.org/10.1016/j.heliyon.2020.e03916 Gendia A, Rehman M, Cota A et al. (2023). Can virtual reality technology be considered as a part of the surgical care pathway? Ann R Coll Surg Engl, 105(1), 2-6. https://doi.org/10.1308/rcsann.2022.0125 Häuser W, Schmutzer G, Brähler E et al. (2014). The impact of body weight and depression on low back pain in a representative polulation sample. Pain Med, 15 (8), 1316-1327. doi: 10.1111/pme.12458 Hoffman HG, Chambers GT, Meyer WJ et al. (2011). Virtual Reality as an Adjunctive Non-pharmacologic Analgesic for Acute Burn Pain During Medical Procedures. Annals of Behavioral Medicine, 41(2), 183–191. https://doi.org/10.1007/s12160-010-9248-7 Kennedy RS, Lane, NE, Berbaum, KS et al. (1993). Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness. Int. J. Aviat. Psychol. 3, 203–220. doi:10.1207/s15327108ijap0303_3 Kieselbach K, Wirtz S & Schenk M (2021). Multimodale Schmerztherapie. Kohlhammer. ISBN 978-3-17-034653-6. Lindner S, Latoschik ME, Rittner H (2020). Virtual Reality als Baustein in der Behandlung akuter und chronischer Schmerzen. Anästhesiol Intensivmed Notfallmed Schmerzther, 55 (09), 549-561. DOI: 10.1055/a-1022-3038.
Health condition or problem studied
- ICD10:
- F45.41
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- To assess the experience of patients with chronic pain with virtual reality in the context of a feasibility study. Based on the results of the study, the possibility of patient-oriented VR-based interventions will be explored.
Endpoints
- Primary outcome:
- Experiences with VR (among others via the German Igroup Presence Questionnaire IPQ) and symptoms of cyber-sickness (surveyed with the Simulation Sickness Questionnaire SSQ)
- Secondary outcome:
- Confounding variables (e.g. experience with relaxation exercises; intensity of relaxation and pain as well as diagnoses)
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Interdisziplinäres Schmerzzentrum des Universitätsklinikums Freiburg Freiburg
Recruitment period and number of participants
- Planned study start date:
- 2023-09-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 75
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients with chronic pain who participate in a multimodal pain therapy
Exclusion Criteria
- existing pregnancy - Diseases associated with balance disorders or dizziness - epilepsy - migraine with aura - significant visual or hearing impairment - Injuries to the eyes, face or neck that make it difficult to use VR comfortably (e.g. open wounds or rashes on the face). - Stroke, transient ischaemic attack or surgery to the cervical spine or skull in the last 6 months. - Implanted electrical devices (e.g. neurostimulators, pacemakers) - Susceptibility to claustrophobia - Severe psychological / psychiatric disorders in the past history (e.g. delusional experience, sensory delusions or ego disturbances) - Unable to participate in the study and complete questionnaires due to cognitive or language difficulties.
Addresses
Primary Sponsor
- Address:
- Interdisziplinäres SchmerzzentrumDr. med. Kristin KieselbachBreisacher Straße 11779106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Interdisziplinäres SchmerzzentrumDr. med Kristin KieselbachBreisacher Straße 11779106 FreiburgGermany
- Telephone:
- +49 761 270 93490
- Fax:
- +49 761 270 54840
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Contact for Public Queries
- Address:
- Interdisziplinäres SchmerzzentrumDr. med Kristin KieselbachBreisacher Straße 11779106 FreiburgGermany
- Telephone:
- +49 761 270 93490
- Fax:
- +49 761 270 54840
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Principal Investigator
- Address:
- Interdisziplinäres SchmerzzentrumDr. med Kristin KieselbachBreisacher Straße 11779106 FreiburgGermany
- Telephone:
- +49 761 270 93490
- Fax:
- +49 761 270 54840
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Interdisziplinäres Schmerzzentrum79106 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072500
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-05-02
- Ethics committee number:
- 23-1218_S2
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-08-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry