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Virtual Reality and Meditation for Fibromyalgia
NA trial testing Virtual Reality Meditation in Fibromyalgia in 9 participants. Completed in 2 August 2022.
| Lead sponsor | Tufts University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 31 May 2022 |
| Primary completion | 2 August 2022 |
| Estimated completion | 2 August 2022 |
| Sites | 1 location across United States |
Tufts University
18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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".
| Group | Value | 95% CI |
|---|---|---|
| Virtual Reality Meditation | 4.4 | ± 1.7 |
| Non Virtual REality Medition | 4.8 | ± 1.8 |
This twenty-item self-report questionnaire measures the extent to which the participant felt various emotions right now. There are two scales, positive affect and negative affect. This questionnaire uses a 5-point Likert scale, from 1 (very slightly or not at all) to 5 (extremely). This questionnaire will assess the participant's psychological state. There are 10 items for each scale ad each scale is summed seperately from the items to form a Positive Affect outcome and a Negative Affect scale. The total for each of these scales is 10 to 50. A higher score indicated more of that affect so a hi
| Group | Value | 95% CI |
|---|---|---|
| Virtual Reality Meditation | 25.8 | ± 9.1 |
| Non Virtual Reality Meditation | 27.3 | ± 8.4 |
| Group | Value | 95% CI |
|---|---|---|
| Virtual Reality Meditation | 10.7 | ± .9 |
| Non Virtual Reality Meditation | 11.3 | ± 2.3 |
Measurements of pain thresholds for bilateral trapezius muscles using a pressure algometer which is a fsmall force guage that can apply controlled pressure to specific points on the body. The algometer quantifies the minimum pressure required to induce pain. It is applied to specific muscles and the tester gradually increases the pressure on that muscle belly until the participant reports that the pressure is painful. For our study we applied pressure to the trapezious muscle Pain Threshold is measured in pounds per square inch and the range is from 0 to infinity. A higher score is considered
| Group | Value | 95% CI |
|---|---|---|
| VR Meditation | 1.6 | ± .9 |
| Non VR Meditation | 1.8 | ± 1.4 |
We obtained Systolic and Diastolic blood pressure using an automated BP cuff. We converted these two scores into a single called the Mean Arterial Pressure which is the average pressure in a person's arteries during one cardiac cycle. The equation used is 1/3(SBP)+2/3(DBP). Thus, this outcome is turned into a single value for analysis. A lower score is considered a better scores.
| Group | Value | 95% CI |
|---|---|---|
| VR Meditation | 82.6 | ± 15.1 |
| Non VR Meditation | 81.5 | ± 12.3 |
Heart rate was obtained using an automated BP cuff. The scale is beats per minute with a range of 50 to \~200 beats per minute. A lower score is a more positive score
| Group | Value | 95% CI |
|---|---|---|
| VR Meditation | 75.7 | ± 11.2 |
| Non VR Meditation | 75.2 | ± 11.2 |
Temporal summation involves touching the participants finger multiple times with a precisely calibrated sharp object and asking for their rating of the discomfort experienced from the touch using the NRS. The NRS 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". A lower score is considered a more positive outcome
| Group | Value | 95% CI |
|---|---|---|
| VR Meditation | 1.8 | ± 1.3 |
| Non VR Meditation | 1.6 | ± 1.5 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05512650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing