Virtual Reality and Meditation for Fibromyalgia

NCT05512650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-05-11

Study results available
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Summary

Fibromyalgia (FM) is a particularly debilitating rheumatological syndrome which affects millions of adults in the United States. The condition presents with widespread chronic muscular pain and reduced pain thresholds, fatigue, insomnia, and negative affect. Chronic pain that is caused by FM can have significant effects on physical function, psychological parameters, and overall quality of life. Currently, there is a need for safe and effective non-pharmacologic pain-management strategies for FM, and research has shown that virtual reality (VR) may be a useful tool for some of these clients. The literature has suggested improvements in pain scores on a visual analog scale (VAS) for adults with a variety of rheumatological issues, including FM. Additional research has demonstrated that affect was improved for clients with FM who participated in a 10-minute VR mindfulness session. Such findings highlight the potential benefits of VR and mindfulness meditation for clients with FM. However, there is a great deal that remains unknown about the effectiveness of these pain management techniques. Therefore, this pilot study will examine and compare the effectiveness of combining VR and meditation for improving symptoms of FM in adults. We hypothesize that a VR meditation session will facilitate greater improvements in pain, affect, and physiological vital stats as compared to a non-immersive meditation intervention.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Virtual Reality Meditation

Participants will be set up in the VR equipment. They will engage and follow along with a 10-20 minute guided meditation through the VR. The meditation program may include simulated movement, relaxing music, and the voice of a meditation guide. The research team member will supervise the session, ensuring safety of the subject is maintained.

DEVICE

Non-VR Meditation

Participants will engage and follow along with a 10-20 minute guided meditation on a computer screen placed before them. The meditation program may include simulated movement visuals, relaxing music, and the voice of a meditation guide. The research team member will supervise the session, ensuring safety of the subject is maintained.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER
  • Rheumatology Research Foundation

    collaborator OTHER
  • Tufts University

    lead OTHER

Principal Investigators

  • Nancy A Baker · Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-08-02
Completion
2022-08-02
FDA Device
Yes

Countries

  • United States

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 NCT05512650 on ClinicalTrials.gov