Virtual Reality for Symptoms Control in Palliative Care (VRPC)

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Palliative Care; Virtual Reality
• Intervention / Treatment: Device: Samsung Gear VR, Galaxy S8, Applied VR App

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany, 48149
    • Recruiting
    • University hospital Muenster
    • Contact: PD Dr. me.d Philipp Lenz, MD; Phone Number: 0049/152/54957580; Email: Lenz.Philipp@ukmuenster.de
    • Principal Investigator: PD Dr. med. Philipp Lenz, MD
    • Sub-Investigator: Miriam Günther
  • North Rhine-Westphalia
    • Muenster, North Rhine-Westphalia, Germany, 48161
      • Not yet recruiting
      • Palliativnetz Muenster gGmbH
      • Contact: Dr. med. Ulrike Hofmeister, MD; Phone Number: +49 (0)251 1625662; Email: info@palliativnetz-muenster.de
      • Sub-Investigator: Dr. med. Ulrike Hofmeister, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palliative care I; Palliative care	Device: Samsung Gear VR, Galaxy S8, Applied VR App; Virtual Reality Experience
Active Comparator: Control II; Patients with mamma carcinoma and (neo-) adjuvant radiotherapy	Device: Samsung Gear VR, Galaxy S8, Applied VR App; Virtual Reality Experience
Active Comparator: Control III; Patients before colonoscopy	Device: Samsung Gear VR, Galaxy S8, Applied VR App; Virtual Reality Experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain by VAS	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).	peri-interventional
Hospital Anxiety and Depression Scale	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))	peri-interventional

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional pain by Pain-Out-Questionnaire	Functional pain by Pain-Out-Questionnaire, Questionnaire in which the patient can indicate pain according to functionality (physical activity, sleeping, breathing) and feeling associated to pain (helplessness, nausea, drowsiness, Pruritus, diszziness), Scales from 0 (no symptom) to 10 (intense).	peri-interventional
Quality of life by EQ-5D-5L	Quality of life by EQ-5D-5L, 5 Items Questionnaire and Scale from 0 (worst health status) to 100 (perfect health status), indicated by the patients, validated questionnaire according to Hinz et al. (Hinz, A., Kohlmann, T., Stobel-Richter, Y., Zenger, M. & Brahler, E. The quality of life questionnaire EQ-5D-5L: psychometric properties and normative values for the general German population. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 23, 443-447, doi:10.1007/s11136-013-0498-2 (2014).)	peri-interventional

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Palliativnetz Muenster gGmbH
• Investigators: Principal Investigator: Philipp Lenz, MD, Institut of Palliative Care, University Hospital of Muenster

Publications and helpful links

General Publications

• Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23.
• Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
• 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.
• Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
• Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): December 15, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: VRPC2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No