Virtual Reality for Symptoms Control in Palliative Care
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 180
- Locations
- 4
- Primary Endpoint
- Pain by VAS
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Palliative care I
Palliative care
Intervention: Samsung Gear VR, Galaxy S8, Applied VR App (Device)
Control II
Patients with mamma carcinoma and (neo-) adjuvant radiotherapy
Intervention: Samsung Gear VR, Galaxy S8, Applied VR App (Device)
Control III
Patients before colonoscopy
Intervention: Samsung Gear VR, Galaxy S8, Applied VR App (Device)
Outcomes
Primary Outcomes
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))
Secondary Outcomes
- Functional pain by Pain-Out-Questionnaire(peri-interventional)
- Quality of life by EQ-5D-5L(peri-interventional)