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N/A N=9 Randomized Treatment

Virtual Reality and Meditation for Fibromyalgia

Fibromyalgia

Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention) — 4.4; 4.8 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Virtual Reality Meditation (Device); Non-VR Meditation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tufts University
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)
4.4; 4.8
SECONDARY
Positive and Negative Affect Scale [PANAS]
25.8; 27.3; 10.7; 11.3
SECONDARY
Quantitative Sensory Testing (QST) - Pain Threshold
1.6; 1.8
SECONDARY
Blood Pressure
82.6; 81.5
SECONDARY
Heart Rate
75.7; 75.2
SECONDARY
Quantitative Sensory Testing (QST) - Temporal Summation
1.8; 1.6

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05512650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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