Trial Outcomes & Findings for Virtual Reality and Meditation for Fibromyalgia (NCT NCT05512650)

Last Updated: 2025-05-11

Results Overview

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".

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

20 minutes after the 10 minute intervention

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Meditation 1st/Non Virtual Reality Meditation 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 Virtual Reality Meditation: 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.	Non Virtual Reality Meditation 1st/Virtual Reality Meditation 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.
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality and Meditation for Fibromyalgia

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Pain Numerical Rating Scale [NRS] (Change From Pre-intervention to Post-intervention)	4.4 score on a scale Standard Deviation 1.7	4.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 20 minutes post the 10 minute meditation intervention

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.

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Positive and Negative Affect Scale [PANAS] Panas Postivie	25.8 score on a scale Standard Deviation 9.1	27.3 score on a scale Standard Deviation 8.4
Positive and Negative Affect Scale [PANAS] Panas Negative	10.7 score on a scale Standard Deviation .9	11.3 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 20 minutes post the 10 minute meditation intervention

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)

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Quantitative Sensory Testing (QST) - Pain Threshold	1.6 pounds per square inch Standard Deviation .9	1.8 pounds per square inch Standard Deviation 1.4

SECONDARY outcome

Timeframe: Immediately after a 10 minute meditation intervention

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.

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Blood Pressure	82.6 mm Hg Standard Deviation 15.1	81.5 mm Hg Standard Deviation 12.3

SECONDARY outcome

Timeframe: Immediately after a 10 minute meditation intervention

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

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Heart Rate	75.7 Beats per minute Standard Deviation 11.2	75.2 Beats per minute Standard Deviation 11.2

SECONDARY outcome

Timeframe: 20 minutes post the 10 minute meditation intervention

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

Outcome measures

Outcome measures
Measure	Virtual Reality Meditation n=9 Participants 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 Virtual REality Medition n=9 Participants 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.
Quantitative Sensory Testing (QST) - Temporal Summation	1.8 score on a scale Standard Deviation 1.3	1.6 score on a scale Standard Deviation 1.5

Adverse Events

VR Meditation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non VR Meditation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Baker, Professor

Tufts University

Phone: 617 627 5562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Virtual Reality Meditation 1st/ NonVr 2nd n=5 Participants 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.	Non Virtual Reality Meditation 1st/VR Meditaiton 2nd n=4 Participants 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.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants