Virtual Reality and Meditation for Fibromyalgia

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT05512650

Collaborator

Brigham and Women's Hospital (Other), Rheumatology Research Foundation (Other)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Device: Virtual Reality Meditation Device: Non-VR Meditation	N/A

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

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of Virtual Reality for Musculoskeletal Pain

Actual Study Start Date :

May 31, 2022

Actual Primary Completion Date :

Aug 2, 2022

Actual Study Completion Date :

Aug 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VR first 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.	Device: 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. Device: 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.
Active Comparator: VR second 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.	Device: 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. Device: 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.

Arm

Intervention/Treatment

Active Comparator: VR first

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.

Device: 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.

Device: 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.

Active Comparator: VR second

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.

Device: Virtual Reality Meditation

Device: Non-VR Meditation

Outcome Measures

Primary Outcome Measures

Pain Numerical Rating Scale [NRS] (change from pre-intervention to post-intervention) [Pre-intervention and within 20 minutes after intervention at both visits.]
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".

Secondary Outcome Measures

Baseline Survey [Pre-intervention at visit 1]
Obtains demographics, medical history, perceptions/attitudes of pain, and experiences with VR.
Brief Pain Inventory-Short Form [Pre-intervention at both visits.]
Fifteen-item self-report questionnaire that measures participant's various levels of pain severity in the past 24 hours, and perception of the degree to which pain prevents participation in important daily activities (e.g. work, socialization) and enjoyment of life. Eight pain severity items are rated on a 11-point scale of 0 (no pain) to 10 (pain as bad as you can imagine). Seven pain interference items are rated on a 11-point scale of 0 (does not interfere) to 10 (completely interferes).
Pain Catastrophizing Scale [PCS] [Pre-intervention at visit 1.]
Thirteen-item self-report questionnaire that collects data on the types of thoughts and feelings the participants have when in pain. The participants will be asked to rank the degree to which they have certain thoughts and feelings when they are in pain using a 5-point Likert scale, from 0 (not at all) to 4 (all the time).
PROMIS Emotional Distress - Short Form [Pre-intervention at both visits]
24-item self report questionnaire that measures how often participant experiences feelings related to depression, anxiety and anger in the past seven days. These questionnaires have been modified to ask about the past 24 hours. The questionnaire uses a 5-point Likert scale, from 1 (never) to 5 (always). This questionnaire will assess the participant's psychological state.
Fibromyalgia Impact Questionnaire (FIQ) [Pre-intervention at visit 1.]
10-item self-report questionnaire that measures the functional impacts FM had on the participants' life over the last 7 days. Items relate to physical functioning and physical symptoms, as well as psychological impact of FM, and occupational interference.
Simulator Sickness Questionnaire [SSQ] [Within 20 minutes after intervention at both visits.]
List of sixteen symptoms which are commonly experienced by users of virtual reality systems. Participants rate the severity of these symptoms while using the VR system using a 4-point Likert scale from 1 (none) to 4 (severe). This questionnaire will monitor the extent of motion sickness in our participants.
Meditation Experience Questionnaire (MEQ) [Within 20 minutes after intervention at both visits.]
Thirteen-item self-report questionnaire that asks subjects to rate the frequency of occurrence of various experiences, such as fatigue, pleasant/unpleasant thoughts, and thoughts about planning or memories, during meditation intervention to evaluate quality of meditation immersion. Uses 5-point Likert scale from 1 (never) to 5 (almost constantly).
User Engagement Scale (UES) [Within 20 minutes after intervention at both visits.]
Twelve-item self-report questionnaire that measures the participant's perception of how engaged they were with the experience using a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). This questionnaire will determine immersion into the meditation.
Positive and Negative Affect Scale [PANAS] [Pre-intervention and within 20 minutes after intervention at both visits.]
This ten-item self-report questionnaire measures the extent to which the participant felt various emotions right now. 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.
Quantitative Sensory Testing (QST) [Pre-intervention and within 10 minutes after intervention at both visits.]
Measurements of pain thresholds for bilateral trapezius muscles using a pressure algometer and measurement of temporal summation using a Neuropen on the non-dominant middle finger.
Blood Pressure [Pre-intervention and immediately after intervention at both visits.]
Systolic and Diastolic blood pressure will be obtained using an automated BP cuff.
Heart Rate [Pre-intervention and immediately after intervention at both visits.]
Heart rate will be obtained using an automated BP cuff.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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