FibromyalgiaNCT05512650
Virtual Reality and Meditation for Fibromyalgia
A study testing Virtual Reality Meditation and Non-VR Meditation in people with Fibromyalgia, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Virtual Reality Meditation and Non-VR Meditation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Has a pacemaker or defibrillator
- Has a hearing aid
- History of myocardial infarction or other serious cardiovascular condition
- Current peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Pain Management Center
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Use of Virtual Reality for Musculoskeletal Pain
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.
Read the detailed description
Current treatments for fibromyalgia (FM) include pharmaceutical pain medications (ranging from over the counter to prescription opioids) as well as psychological programs with components of relaxation, cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia, and there is little research on psychological interventions for FM.
One treatment that has demonstrated some efficacy for reducing chronic pain is meditation. Various studies have demonstrated that there are generally reductions in affective pain for those who practice meditation. Another promising treatment option for FM is virtual reality (VR). VR is an immersive 3D experience during which the participant wears a headset or helmet which simulates the sensation of being elsewhere. There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.
One preliminary study examined the utility of VR in treating FM. Results from this study showed that positive affect increased after participants engaged in a 10-minute meditation and mindfulness VR session. Further, they found a slight reduction in the negative impact of FM on overall life and wellbeing, as measured by the FM Impact Questionnaire (FIQ). However, small sample sizes and the addition of other adjunctive therapies limit the significance of these study results. Additional research on VR and meditation for the treatment of FM and other rheumatological conditions also demonstrated reductions in pain scores, offering promising data on meditation and VR being used in combination.
Given the promising literature on VR and meditation, this study will aim to further the field of knowledge surrounding use of VR meditation for reducing pain and increasing affect for adults with FM. Despite the encouraging data on using these interventions for FM, it is unknown whether the immersive aspect of the VR is helping to improve results. This pilot study will aim to address this question by comparing an immersive VR meditation session with a non-immersive, typical meditation for FM patients.
- Conditions
- Fibromyalgia
- Being tested
- Virtual Reality Meditation, Non-VR Meditation
- Keywords
- Fibromyalgia, Virtual Reality, Meditation, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality MeditationDevice
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.
Non-VR MeditationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Virtual Reality Meditation; Device: Non-VR Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 20 minutes after the 10 minute intervention
Secondary outcomes (5)
Positive and Negative Affect Scale [PANAS]
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 high score on the Positive Affect is considered better while a lower score on the Negative Affect is considered better.
Measured: 20 minutes post the 10 minute meditation intervention
Quantitative Sensory Testing (QST) - Pain Threshold
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 to be a more positive outcome (e.g. the person is tolerating more pressure before identifying it is painful)
Measured: 20 minutes post the 10 minute meditation intervention
Blood Pressure
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.
Measured: Immediately after a 10 minute meditation intervention
Heart Rate
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
Measured: Immediately after a 10 minute meditation intervention
Quantitative Sensory Testing (QST) - Temporal Summation
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
Measured: 20 minutes post the 10 minute meditation intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start31 May 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Rheumatology Research Foundation
- Responsible party
- Principal investigator, Nancy Baker, Tufts University
- Investigators
- Nancy A Baker, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512650
- Sponsor's protocol ID
- 2021P001499
- Status last verified
- May 2025
- First submitted
- 12 Aug 2022
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31872189Botella 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.
PubMed 23496678Ahmadpour 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.
PubMed 31306747Herrero 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.
PubMed 24892201Hennard J. A protocol and pilot study for managing fibromyalgia with yoga and meditation. Int J Yoga Therap. 2011;(21):109-21.
PubMed 22398352Ngian 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.
PubMed 21303476
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality for Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05512650
- Acronym / sponsor ID
- 2021P001499
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Virtual Reality, Meditation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Rheumatology Research Foundation
- Study start
- 31 May 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current treatments for fibromyalgia (FM) include pharmaceutical pain medications (ranging from over the counter to prescription opioids) as well as psychological programs with components of relaxation, cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia, and there is little research on psychological interventions for FM.
One treatment that has demonstrated some efficacy for reducing chronic pain is meditation. Various studies have demonstrated that there are generally reductions in affective pain for those who practice meditation. Another promising treatment option for FM is virtual reality (VR). VR is an immersive 3D experience during which the participant wears a headset or helmet which simulates the sensation of being elsewhere. There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.
One preliminary study examined the utility of VR in treating FM. Results from this study showed that positive affect increased after participants engaged in a 10-minute meditation and mindfulness VR session. Further, they found a slight reduction in the negative impact of FM on overall life and wellbeing, as measured by the FM Impact Questionnaire (FIQ). However, small sample sizes and the addition of other adjunctive therapies limit the significance of these study results. Additional research on VR and meditation for the treatment of FM and other rheumatological conditions also demonstrated reductions in pain scores, offering promising data on meditation and VR being used in combination.
Given the promising literature on VR and meditation, this study will aim to further the field of knowledge surrounding use of VR meditation for reducing pain and increasing affect for adults with FM. Despite the encouraging data on using these interventions for FM, it is unknown whether the immersive aspect of the VR is helping to improve results. This pilot study will aim to address this question by comparing an immersive VR meditation session with a non-immersive, typical meditation for FM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR first | Active comparator | Device: Virtual Reality Meditation, Device: Non-VR MeditationAt 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. |
| VR second | Active comparator | Device: Virtual Reality Meditation, Device: Non-VR MeditationAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Unwilling to put on VR headset
- Experience a seizure in the last 5 years
- Cognitive impairment
- Hearing/visual deficit
- Active, contagious skin infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality MeditationParticipants 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 | VR first, VR second |
| Non-VR MeditationParticipants 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. | Device | VR first, VR second |
Primary outcome
Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)
Time frame: 20 minutes after the 10 minute 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".
5 secondary outcomes
Positive and Negative Affect Scale [PANAS]
Time frame: 20 minutes post the 10 minute meditation intervention
Quantitative Sensory Testing (QST) - Pain Threshold
Time frame: 20 minutes post the 10 minute meditation intervention
Blood Pressure
Time frame: Immediately after a 10 minute meditation intervention
Heart Rate
Time frame: Immediately after a 10 minute meditation intervention
Quantitative Sensory Testing (QST) - Temporal Summation
Time frame: 20 minutes post the 10 minute meditation intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31872189Venuturupalli 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.
- Background: PubMed 23496678Botella 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.
- Background: PubMed 31306747Ahmadpour 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.
- Background: PubMed 24892201Herrero 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.
- Background: PubMed 22398352Hennard J. A protocol and pilot study for managing fibromyalgia with yoga and meditation. Int J Yoga Therap. 2011;(21):109-21.
- Background: PubMed 21303476Ngian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Baker principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Meditation and Non-VR Meditation in people with Fibromyalgia, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention) (time frame: 20 minutes after the 10 minute intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512650, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.