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Behavioural Intervention
Virtual Reality Therapy for Cancer-Related Symptoms
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English speaker (written and spoken)
Be older than 18 years old
Must not have
Current Hospice or palliative care only recipients
Impaired or uncorrected hearing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of intervention (4 weeks)
Summary
"This trial aims to test a new method of managing symptoms in cancer patients after treatment using a Virtual Reality program. The goal is to see how this program affects pain, fatigue, sleep, and anxiety in
Who is the study for?
This trial is for cancer patients dealing with chronic pain, fatigue, sleep issues, or anxiety after their treatments. Participants should be comfortable using a Virtual Reality (VR) program at home and have symptoms that persist following cancer therapy.
What is being tested?
The study tests a Multimodal Integrative Therapy (MIT) delivered through VR called Relievrx, designed to manage symptoms like pain and anxiety in post-treatment cancer patients. The effectiveness of this FDA-authorized home-use program will be evaluated.
What are the potential side effects?
Since the intervention involves non-invasive VR therapy, side effects may include discomfort from wearing the VR headset, dizziness or motion sickness during use. No significant medical side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can speak and write in English.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving only hospice or palliative care.
Select...
I have hearing problems that haven't been corrected.
Select...
I don't have any conditions that would prevent wearing a VR mask.
Select...
I have not been hospitalized for a severe psychiatric condition in the last 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of intervention (4 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of intervention (4 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Audio effect on perceived anxiety
Audio effect on perceived depression
Audio effect on perceived fatigue
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Virtual reality armExperimental Treatment1 Intervention
In the virtual reality intervention, participants will complete the scheduled educational module five times in the week of the intervention. This VR is assisting users in using immersive reality to reduce pain, learning cognitive and behavior self-coping skills and retraining the pain pathways. There are several sessions, which will be delivered using an all-in-one head-mounted display. Each session varies in duration approximately from 3 to 15 minutes.
Group II: Audio Mp4 armPlacebo Group1 Intervention
In the audio intervention, participants will complete the scheduled module 5 times a week of the intervention. The content is similar to that of the VR, which will be delivered by the audio player. Each session varies in duration approximately from 3 to 15 minutes.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,084 Total Patients Enrolled