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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 Schmerzzentrum
Dr. med. Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
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 Schmerzzentrum
Dr. med Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
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 Schmerzzentrum
Dr. med Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
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 Schmerzzentrum
Dr. med Kristin Kieselbach
Breisacher Straße 117
79106 Freiburg
Germany
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 Schmerzzentrum
79106 Freiburg
Germany
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 Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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:
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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