Clinical trial NCT03698526: Virtual Reality for Symptoms Control in Palliative Care
Official title: Virtual Reality for Symptoms Control in Palliative Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Virtual Reality
Pain
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Palliativnetz Muenster gGmbH
First posted: 2018-10-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain by VAS
timeFrame: peri-interventional
measure: Hospital Anxiety and Depression Scale
timeFrame: peri-interventional
Secondary outcomes:
measure: Functional pain by Pain-Out-Questionnaire
timeFrame: peri-interventional
measure: Quality of life by EQ-5D-5L
timeFrame: peri-interventional
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Palliativnetz Muenster gGmbH
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Institut of Palliative Care, University Hospital of Muenster
name: Philipp Lenz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
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