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Clinical 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.

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03698526
Study type Interventional
Source University Hospital Muenster
Contact Philipp Lenz, MD
Phone +4915254957580
Email Lenz.Philipp@ukmuenster.de
Status Recruiting
Phase N/A
Start date September 1, 2018
Completion date December 15, 2019

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