Palliative CareVRPCNCT03698526
Virtual Reality for Symptoms Control in Palliative Care
A study testing Samsung Gear VR, Galaxy S8, Applied VR App in people with Palliative Care and Virtual Reality, run by University Hospital Muenster at 2 sites in Germany.
Trial summary
The aim of this study is to evaluate how Virtual Reality (VR) can be used to control symptoms and improve the quality of life in palliative care. The interventional prospective case control study is planned to contain five phases including two control groups. The following describes only phase one to three. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Virtual Reality, Pain
- What is being tested?
- Samsung Gear VR, Galaxy S8, Applied VR App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years
- 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
Who cannot join
- Epileptic seizures in medical history
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Not yet recruiting
Palliativnetz Muenster gGmbH
Münster, North Rhine-Westphalia, 48161
Dr. med. Ulrike Hofmeister, MD, +49 (0)251 1625662, info@palliativnetz-muenster.de
Dr. med. Ulrike Hofmeister, MD
- Recruiting
University Hospital Muenster
Münster, 48149
PD Dr. me.d Philipp Lenz, MD, 0049/152/54957580, Lenz.Philipp@ukmuenster.de
PD Dr. med. Philipp Lenz, MD
About this study
The aim of this study is to evaluate how Virtual Reality (VR) can be used to control symptoms and improve the quality of life in palliative care. The interventional prospective case control study is planned to contain five phases including two control groups. The following describes only phase one to three.
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).
Read more
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.
Read the detailed description
Pilot phase:
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
- Palliative Care, Virtual Reality, Pain
- Being tested
- Samsung Gear VR, Galaxy S8, Applied VR App
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung Gear VR, Galaxy S8, Applied VR AppDevice
Virtual Reality Experience
| Study group | Role | What they receive |
|---|---|---|
| Palliative care I | Active comparator | Palliative care Receives: Device: Samsung Gear VR, Galaxy S8, Applied VR App |
| Control II | Active comparator | Patients with mamma carcinoma and (neo-) adjuvant radiotherapy Receives: Device: Samsung Gear VR, Galaxy S8, Applied VR App |
| Control III | Active comparator | Patients before colonoscopy Receives: Device: Samsung Gear VR, Galaxy S8, Applied VR App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain by VAS
Pain by VAS (visual analogue scale), Pain is indicated on a 100mm visual scale, the patient can report no pain (0 mm) to maximum pain (100mm).
Measured: peri-interventional
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale, Questionnaire to indicate anxiety and depression, 14 questions (7 depression, 7 anxiety) with 4 possibilities to answer, validated questionnaire according to Zigmond et al. (Zigmond, A. S. \& Snaith, R. P. The hospital anxiety and depression scale. Acta psychiatrica Scandinavica 67, 361-370 (1983))
Measured: peri-interventional
Secondary outcomes (2)
Functional pain by Pain-Out-Questionnaire
Functional pain by Pain-Out-Questionnaire, Questionnaire in which the patient can indicate pain according to functionality (physical activity, sleeping, breathing) and feeling associated to pain (helplessness, nausea, drowsiness, Pruritus, diszziness), Scales from 0 (no symptom) to 10 (intense).
Measured: peri-interventional
Quality of life by EQ-5D-5L
Quality of life by EQ-5D-5L, 5 Items Questionnaire and Scale from 0 (worst health status) to 100 (perfect health status), indicated by the patients, validated questionnaire according to Hinz et al. (Hinz, A., Kohlmann, T., Stobel-Richter, Y., Zenger, M. \& Brahler, E. The quality of life questionnaire EQ-5D-5L: psychometric properties and normative values for the general German population. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 23, 443-447, doi:10.1007/s11136-013-0498-2 (2014).)
Measured: peri-interventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Palliativnetz Muenster gGmbH
- Responsible party
- Sponsor
- Investigators
- Philipp Lenz, MD, Principal investigator, Institut of Palliative Care, University Hospital of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698526
- Sponsor's protocol ID
- VRPC2018
- Acronym
- VRPC
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17509812Gold 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.
PubMed 29053848Mosadeghi 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.
PubMed 27349654Mahrer 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.
PubMed 19272275Hoffman 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.
PubMed 11587113
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Symptoms Control in Palliative Care
- ClinicalTrials.gov ID
- NCT03698526
- Acronym / sponsor ID
- VRPC / VRPC2018
- Conditions
- Palliative Care, Virtual Reality, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Palliativnetz Muenster gGmbH
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 9 Oct 2018 (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.
The aim of this study is to evaluate how Virtual Reality (VR) can be used to control symptoms and improve the quality of life in palliative care. The interventional prospective case control study is planned to contain five phases including two control groups. The following describes only phase one to three.
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.
Detailed description
Pilot phase:
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palliative care I | Active comparator | Device: Samsung Gear VR, Galaxy S8, Applied VR AppPalliative care |
| Control II | Active comparator | Device: Samsung Gear VR, Galaxy S8, Applied VR AppPatients with mamma carcinoma and (neo-) adjuvant radiotherapy |
| Control III | Active comparator | Device: Samsung Gear VR, Galaxy S8, Applied VR AppPatients before colonoscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum age of 18 years
- 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
Key exclusion criteria (7 listed)
- Epileptic seizures in medical history
- Patients with claustrophobia
- Patients with tendency to vertigo and motion sickness
- Age under 18 years
- No informed written consent
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 |
|---|---|---|
| Samsung Gear VR, Galaxy S8, Applied VR AppVirtual Reality Experience | Device | Control II, Control III, Palliative care I |
Primary outcome
Pain by VAS
Time frame: peri-interventional
Pain by VAS (visual analogue scale), Pain is indicated on a 100mm visual scale, the patient can report no pain (0 mm) to maximum pain (100mm).
Hospital Anxiety and Depression Scale
Time frame: peri-interventional
Hospital Anxiety and Depression Scale, Questionnaire to indicate anxiety and depression, 14 questions (7 depression, 7 anxiety) with 4 possibilities to answer, validated questionnaire according to Zigmond et al. (Zigmond, A. S. \& Snaith, R. P. The hospital anxiety and depression scale. Acta psychiatrica Scandinavica 67, 361-370 (1983))
2 secondary outcomes
Functional pain by Pain-Out-Questionnaire
Time frame: peri-interventional
Quality of life by EQ-5D-5L
Time frame: peri-interventional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 17509812Teunissen 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.
- Background: PubMed 29053848Gold 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.
- Background: PubMed 27349654Mosadeghi 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.
- Background: PubMed 19272275Mahrer 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.
- Background: PubMed 11587113Hoffman 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.
- 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. This study is not recruiting at the moment.
Philipp Lenz, MD principal investigator
Institut of Palliative Care, University Hospital of Muenster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samsung Gear VR, Galaxy S8, Applied VR App in people with Palliative Care and Virtual Reality, run by University Hospital Muenster at 2 sites in Germany.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Lenz, MD (+4915254957580, Lenz.Philipp@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain by VAS (time frame: peri-interventional). The study lists 2 primary outcomes in all. 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 NCT03698526, which also lists 5 linked publications.
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 10 Oct 2018; AzTrials last refreshed its copy on 31 Oct 2026.