Virtual Reality for Symptoms Control in Palliative Care

NCT03698526 | Unknown

• 1 other identifier: VRPC2018
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Palliative Care; Virtual Reality; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional pain by Pain-Out-Questionnaire

  peri-interventional

• Quality of life by EQ-5D-5L

  peri-interventional

Study Arms (3)

Palliative care I

ACTIVE COMPARATOR

Palliative care

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

Control II

ACTIVE COMPARATOR

Patients with mamma carcinoma and (neo-) adjuvant radiotherapy

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

Control III

ACTIVE COMPARATOR

Patients before colonoscopy

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

Interventions

Samsung Gear VR, Galaxy S8, Applied VR App DEVICE

Virtual Reality Experience

Control II; Control III; Palliative care I

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age of 18 years
• Patient understands information for participation
• Patients are able to give informed written consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Palliativnetz Muenster gGmbH: collaborator

Study Sites (2)

Palliativnetz Muenster gGmbH

Münster, North Rhine-Westphalia, 48161, Germany

NOT YET RECRUITING

University Hospital Muenster

Münster, 48149, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 17509812 BACKGROUND

• 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.

  PMID: 29053848 BACKGROUND

• 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.

  PMID: 27349654 BACKGROUND

• 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.

  PMID: 19272275 BACKGROUND

• 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.

  PMID: 11587113 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Lenz, MD

  Institut of Palliative Care, University Hospital of Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Lenz, MD

CONTACT

+4915254957580; Lenz.Philipp@ukmuenster.de

Renate Schmidt, MD

CONTACT

+492518346135; Renate.Schmidt@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 15, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)