Virtual Reality and Meditation for Fibromyalgia

NCT05512650 | Completed Results FDA Device

• 1 other identifier: 2021P001499
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Virtual Reality; Meditation; Pain

Outcome Measures

Primary Outcomes (1)

• Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)

  Measures the intensity of pain on an 11-point scale, ranging from 0-10. 0 is "no pain", and 10 is "pain as bad as you can imagine".

  20 minutes after the 10 minute intervention

Secondary Outcomes (5)

• Positive and Negative Affect Scale [PANAS]

  20 minutes post the 10 minute meditation intervention

• Quantitative Sensory Testing (QST) - Pain Threshold

  20 minutes post the 10 minute meditation intervention

• Blood Pressure

  Immediately after a 10 minute meditation intervention

• Heart Rate

  Immediately after a 10 minute meditation intervention

• Quantitative Sensory Testing (QST) - Temporal Summation

  20 minutes post the 10 minute meditation intervention

Study Arms (2)

VR first

ACTIVE COMPARATOR

At their first visit, subjects will engage in a virtual reality meditation while wearing the VR headset. At their second visit, they will engage in a non-immersive meditation without the 3D VR aspect.

Device: Virtual Reality Meditation; Device: Non-VR Meditation

VR second

ACTIVE COMPARATOR

At their first visit, subjects will engage in a non-immersive meditation without the 3D VR aspect. At their second visit, they will engage in a virtual reality meditation while wearing the VR headset.

Device: Virtual Reality Meditation; Device: Non-VR Meditation

Interventions

Virtual Reality Meditation DEVICE

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.

VR first; VR second

Non-VR Meditation DEVICE

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.

VR first; VR second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 and older (no upper limit)
• Diagnosis of fibromyalgia with a minimum average pain level of 3 over the last week
• English-speaking
• Willing and able to visit the Brigham and Women's Pain Management Center site on two separate occasions to participate in the study

You may not qualify if:

• Unwilling to put on VR headset
• Experience a seizure in the last 5 years
• Cognitive impairment
• Hearing/visual deficit
• Active, contagious skin infection
• Eye infections
• Has a pacemaker or defibrillator
• Has a hearing aid
• History of myocardial infarction or other serious cardiovascular condition
• Current peripheral neuropathy

Sponsors & Collaborators

• Tufts University: lead
• Brigham and Women's Hospital: collaborator
• Rheumatology Research Foundation: collaborator

Study Sites (1)

Brigham and Women's Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (6)

• Venuturupalli RS, Chu T, Vicari M, Kumar A, Fortune N, Spielberg B. Virtual Reality-Based Biofeedback and Guided Meditation in Rheumatology: A Pilot Study. ACR Open Rheumatol. 2019 Nov 11;1(10):667-675. doi: 10.1002/acr2.11092. eCollection 2019 Dec.

  PMID: 31872189 BACKGROUND

• Botella C, Garcia-Palacios A, Vizcaino Y, Herrero R, Banos RM, Belmonte MA. Virtual reality in the treatment of fibromyalgia: a pilot study. Cyberpsychol Behav Soc Netw. 2013 Mar;16(3):215-23. doi: 10.1089/cyber.2012.1572.

  PMID: 23496678 BACKGROUND

• Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.

  PMID: 31306747 BACKGROUND

• Herrero R, Garcia-Palacios A, Castilla D, Molinari G, Botella C. Virtual reality for the induction of positive emotions in the treatment of fibromyalgia: a pilot study over acceptability, satisfaction, and the effect of virtual reality on mood. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):379-84. doi: 10.1089/cyber.2014.0052.

  PMID: 24892201 BACKGROUND

• Hennard J. A protocol and pilot study for managing fibromyalgia with yoga and meditation. Int J Yoga Therap. 2011;(21):109-21.

  PMID: 22398352 BACKGROUND

• Ngian GS, Guymer EK, Littlejohn GO. The use of opioids in fibromyalgia. Int J Rheum Dis. 2011 Feb;14(1):6-11. doi: 10.1111/j.1756-185X.2010.01567.x. Epub 2010 Aug 23.

  PMID: 21303476 BACKGROUND

Related Links

• Centers for Disease Control (CDC) on Fibromyalgia

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small Sample

Results Point of Contact

• Title: Nancy Baker, Professor
• Organization: Tufts University

nancy.baker@tufts.edu

617 627 5562

Study Officials

• Nancy A Baker

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of and Associate Professor in Department of Occupational Therapy

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 23, 2022
• Study Start: May 31, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)