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The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application

NCT04042090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-09-29

No results posted yet for this study

Summary

This study evaluates the effect of therapeutic Virtual Reality (VR) on quality of life of 60 patients with non-specific chronic low-back pain. 30 patients will be included in the intervention group. These patients will use Reducept, a therapeutic virtual reality application based on diverse cognitive therapies (ACT, mindfulness, EMDR, hypnotherapy), at home over a period of 28 days, for at least 10 minutes each day. This will be an add-on intervention next to standard care, while the patient is waiting to receive actual treatment for chronic pain. 30 patients in the control group will only receive standard care, whilst waiting to receive actual treatment for their chronic pain. Intervention and control group will be compared on a number of outcome measures related to quality of life before using VR, during VR use, just after use and 4 months after final use. This explorative study is necessary to get first insights as a basis for a confirmative study.

Conditions

  • Back Pain Lower Back Chronic
  • Quality of Life

Interventions

DEVICE

Reducept, virtual reality

The VR serious game Reducept is a novel psychological VR intervention for treating chronic pain. It incorporates several psychological therapies into one application: hypnotherapy, mindfulness, ACT and EMDR. Reducept has been made in co-creation with patients, researchers, psychologists and developers and can be installed and played on a VR goggles. It consists of an education module and three games.

Sponsors & Collaborators

  • Rijnstate Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Harry van Goor, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2021-01-15
Completion
2021-06-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042090 on ClinicalTrials.gov