Virtual Reality for Symptoms Control in Palliative Care
NCT ID: NCT03698526
Last Updated: 2018-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
180 participants
INTERVENTIONAL
2018-09-01
2019-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In the pilot phase patients get a one-time application of the VR-Technology. After that, two control groups will be recruited from patients with 1. mamma carcinoma and the indication of (neo-) adjuvant radiotherapy and 2. before a colonoscopy-treatment. Both groups receive the VR application before treatment (radiotherapy/colonoscopy).
This first part proofs the application of Virtual Reality on patients in palliative care with the aim to control symptoms and reduce pain and anxiety.
The clinical study hypothesis bases on the assumption that VR reduces pain and anxiety and may have a positive influence on their quality of life.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
VR for Symptom Control and Wellbeing
NCT04821466
Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit
NCT04966260
Virtual Reality for Improving Symptoms in Palliative Care
NCT05197894
Pilot Study Evaluating the Therapeutic Effects of Passive Exposure Virtual Reality on Pain, Anxiety, Fatigue, and Well-being in Patients With Complex Palliative Care Needs.
NCT07214090
Virtual Reality Within Palliative Care (VR-SPC)
NCT07109050
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the enrolment and consent of participation the patient receives a questionnaire consisting of different independent assessments. The visual analogue scale with values from 1 to 10 quantifies subjective pain. A functional pain questionnaire (Pain-Out) is developed to assess the pain in between the last seven days, the associated limitations, the actions and side effects of combined pain therapy.
To measure the generic health-related quality of life the patient is asked to answer the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L).
A Virtual Reality application is offered immediately after the questionnaire has been completed. Following the application of VR the patient will receive VAS and functional pain questionnaires again to assess the change from baseline.
Control phase:
The following control phase is to review the effectiveness of VR application on the basis of two different control groups. In a randomized setting 30 patients with mamma carcinoma receive an application of VR before their radiotherapy. The second control group consists of 40 patients with an individual indication of a colonoscopy.
Instead of pain by VAS and QoL in the pilot phase each patient receives now the Hospital Anxiety and Depression Scale (HADS) before and after the application. The Functional Pain Questionnaire remains with the control group of patients with mamma carcinoma.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palliative care I
Palliative care
Samsung Gear VR, Galaxy S8, Applied VR App
Virtual Reality Experience
Control II
Patients with mamma carcinoma and (neo-) adjuvant radiotherapy
Samsung Gear VR, Galaxy S8, Applied VR App
Virtual Reality Experience
Control III
Patients before colonoscopy
Samsung Gear VR, Galaxy S8, Applied VR App
Virtual Reality Experience
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Samsung Gear VR, Galaxy S8, Applied VR App
Virtual Reality Experience
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient understands information for participation
* Patients are able to give informed written consent
* (Informed written) consent prior inclusion in study
* study arm I: Indication for palliative care due to any advanced life-limiting and progressive diseases
* control II: Patients with mamma carcinoma and (neo-) adjuvant radiotherapy
* control III: Patients before colonoscopy
Exclusion Criteria
* Patients with claustrophobia
* Patients with tendency to vertigo and motion sickness
* Age under 18 years
* No informed written consent
* Inability to understand information for participation, language difficulties (foreign nationals), hardness of hearing
* Blindness
18 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Palliativnetz Muenster gGmbH
UNKNOWN
University Hospital Muenster
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philipp Lenz, MD
Role: PRINCIPAL_INVESTIGATOR
Institut of Palliative Care, University Hospital of Muenster
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Palliativnetz Muenster gGmbH
Münster, North Rhine-Westphalia, Germany
University Hospital Muenster
Münster, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23.
Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VRPC2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.