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Virtual Reality and Meditation for Fibromyalgia

Use of Virtual Reality for Musculoskeletal Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05512650
Enrollment
9
Registered
2022-08-23
Start date
2022-05-31
Completion date
2022-08-02
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Virtual Reality, Meditation, Pain

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.

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.

Interventions

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.

DEVICENon-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

Brigham and Women's Hospital
CollaboratorOTHER
Rheumatology Research Foundation
CollaboratorOTHER
Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults ages 18 and older (no upper limit) 2. Diagnosis of fibromyalgia with a minimum average pain level of 3 over the last week 3. English-speaking 4. 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

1. Unwilling to put on VR headset 2. Experience a seizure in the last 5 years 3. Cognitive impairment 4. Hearing/visual deficit 5. Active, contagious skin infection 6. Eye infections 7. Has a pacemaker or defibrillator 8. Has a hearing aid 9. History of myocardial infarction or other serious cardiovascular condition 10. Current peripheral neuropathy

Design outcomes

Primary

MeasureTime frameDescription
Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)20 minutes after the 10 minute interventionMeasures 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.

Secondary

MeasureTime frameDescription
Positive and Negative Affect Scale [PANAS]20 minutes post the 10 minute meditation interventionThis 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.
Quantitative Sensory Testing (QST) - Pain Threshold20 minutes post the 10 minute meditation interventionMeasurements 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)
Blood PressureImmediately after a 10 minute meditation interventionWe 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.
Heart RateImmediately after a 10 minute meditation interventionHeart 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
Quantitative Sensory Testing (QST) - Temporal Summation20 minutes post the 10 minute meditation interventionTemporal 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Virtual Reality Meditation 1st/ NonVr 2nd
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. 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.
5
Non Virtual Reality Meditation 1st/VR Meditaiton 2nd
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. 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.
4
Total9

Baseline characteristics

CharacteristicVirtual Reality Meditation 1st/ NonVr 2ndNon Virtual Reality Meditation 1st/VR Meditaiton 2ndTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants4 Participants9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants4 Participants8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants4 Participants9 Participants
Region of Enrollment
United States
5 participants4 participants9 participants
Sex: Female, Male
Female
5 Participants4 Participants9 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 9
other
Total, other adverse events
0 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 9

Outcome results

Primary

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.

Time frame: 20 minutes after the 10 minute intervention

ArmMeasureValue (MEAN)Dispersion
Virtual Reality MeditationPain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)4.4 score on a scaleStandard Deviation 1.7
Non Virtual REality MeditionPain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)4.8 score on a scaleStandard Deviation 1.8
Secondary

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.

Time frame: Immediately after a 10 minute meditation intervention

ArmMeasureValue (MEAN)Dispersion
Virtual Reality MeditationBlood Pressure82.6 mm HgStandard Deviation 15.1
Non Virtual REality MeditionBlood Pressure81.5 mm HgStandard Deviation 12.3
Secondary

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

Time frame: Immediately after a 10 minute meditation intervention

ArmMeasureValue (MEAN)Dispersion
Virtual Reality MeditationHeart Rate75.7 Beats per minuteStandard Deviation 11.2
Non Virtual REality MeditionHeart Rate75.2 Beats per minuteStandard Deviation 11.2
Secondary

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.

Time frame: 20 minutes post the 10 minute meditation intervention

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality MeditationPositive and Negative Affect Scale [PANAS]Panas Postivie25.8 score on a scaleStandard Deviation 9.1
Virtual Reality MeditationPositive and Negative Affect Scale [PANAS]Panas Negative10.7 score on a scaleStandard Deviation 0.9
Non Virtual REality MeditionPositive and Negative Affect Scale [PANAS]Panas Postivie27.3 score on a scaleStandard Deviation 8.4
Non Virtual REality MeditionPositive and Negative Affect Scale [PANAS]Panas Negative11.3 score on a scaleStandard Deviation 2.3
Secondary

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)

Time frame: 20 minutes post the 10 minute meditation intervention

ArmMeasureValue (MEAN)Dispersion
Virtual Reality MeditationQuantitative Sensory Testing (QST) - Pain Threshold1.6 pounds per square inchStandard Deviation 0.9
Non Virtual REality MeditionQuantitative Sensory Testing (QST) - Pain Threshold1.8 pounds per square inchStandard Deviation 1.4
Secondary

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

Time frame: 20 minutes post the 10 minute meditation intervention

ArmMeasureValue (MEAN)Dispersion
Virtual Reality MeditationQuantitative Sensory Testing (QST) - Temporal Summation1.8 score on a scaleStandard Deviation 1.3
Non Virtual REality MeditionQuantitative Sensory Testing (QST) - Temporal Summation1.6 score on a scaleStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026