Pain Clinical Trial
Official title:
Virtual Reality for Symptoms Control in Palliative Care
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.
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.
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