Virtual Reality for Symptoms Control in Palliative Care (VRPC)

University Hospital Muenster

Status: Unknown

Conditions: Pain; Virtual Reality; Palliative Care

Treatments: Device: Samsung Gear VR, Galaxy S8, Applied VR App

Study type: Interventional

Funder types: Other

Identifiers

NCT03698526

VRPC2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Palliative care I

Active Comparator group

Description:

Palliative care

Treatment:

Device: Samsung Gear VR, Galaxy S8, Applied VR App

Control II

Active Comparator group

Description:

Patients with mamma carcinoma and (neo-) adjuvant radiotherapy

Treatment:

Device: Samsung Gear VR, Galaxy S8, Applied VR App

Control III

Active Comparator group

Description:

Patients before colonoscopy

Treatment:

Device: Samsung Gear VR, Galaxy S8, Applied VR App