Virtual Reality for Symptoms Control in Palliative Care

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Virtual Reality for Symptoms Control in Palliative Care

Conditions
-----------------
Pain, Palliative Care, Virtual Reality

Intervention / Treatment
-----------------
* Device: Samsung Gear VR, Galaxy S8, Applied VR App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palliative care I<br>Palliative care | Device: Samsung Gear VR, Galaxy S8, Applied VR App<br>* Virtual Reality Experience<br>|
| Active Comparator: Control II<br>Patients with mamma carcinoma and (neo-) adjuvant radiotherapy | Device: Samsung Gear VR, Galaxy S8, Applied VR App<br>* Virtual Reality Experience<br>|
| Active Comparator: Control III<br>Patients before colonoscopy | Device: Samsung Gear VR, Galaxy S8, Applied VR App<br>* Virtual Reality Experience<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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)) | peri-interventional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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).) | peri-interventional |