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Sleep and Pain Intervention for Chronic Pain Using Virtual Reality Pilot Study

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ClinicalTrials.gov Identifier: NCT04253691
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Christina McCrae, University of Missouri-Columbia

Brief Summary:

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70% of patients reporting sleep difficulties. It is well documented that, alongside a high comorbidity with chronic pain, chronic insomnia also has high comorbidity with, and is a risk factor for, developing an anxiety disorders. This clinical trial will examine the effects of virtual reality (VR) meditation environments on patients with pain- and insomnia-related anxiety. The purpose of this study is to examine the benefits of using VR meditation with patients with chronic pain and chronic sleep disturbance so that clinicians can more effectively treat core causes to symptoms and reduce counterproductive therapies.

Research objectives include:

  1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
  2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
  3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
  4. To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).

Condition or disease Intervention/treatment Phase
Insomnia Chronic Pain, Chronic Device: Virtual Reality Mediated Relaxation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep and Pain Intervention for Chronic Pain Using Virtual Reality Pilot Study
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Virtual Reality Based Relaxation Therapy
This is a pilot trial with one treatment condition (VR mediation).
Device: Virtual Reality Mediated Relaxation
Participants will combine the Virtual Reality technique with the Stimulus Control technique. When they go to bed at night, they will undergo the VR mediated Relaxation procedure first. If they do not fall asleep within 15-20 minutes, they get out of bed as described in the Stimulus Control Instructions. If they awake during the night, they run through the VR mediated relaxation procedure once. If they do not fall back asleep within 15-20 minutes, they should get out of bed. Their workbook will contain a handout that outlines the details. Participants will be encouraged to refer to it at home if they forget any part of the procedure.




Primary Outcome Measures :
  1. Daily Electronic Sleep/Pain Diaries [ Time Frame: 8 weeks ]
    Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality) and fatigue

  2. PROMIS-57 Profile v2.0 parameters [ Time Frame: 8 weeks ]
    Fatigue, sleep, pain interference and intensity, anxiety and depression measurement

  3. McGill Pain Questionnaire [ Time Frame: 8 weeks ]
    Pain measurement

  4. Pain Disability Inventory [ Time Frame: 8 weeks ]
    Pain measurement

  5. Objective Daily Sleep Actiwatch-2 [ Time Frame: 8 weeks ]
    Sleep latency, wake after sleep onset and efficiency measurement

  6. Insomnia Severity Index [ Time Frame: 8 weeks ]
    Insomnia severity measurement


Secondary Outcome Measures :
  1. Patient centered outcomes questionnaire [ Time Frame: 8 weeks ]
    The Patient Centered Outcomes questionnaire assesses four domains (pain, fatigue, emotional distress, and interference with daily activities) relevant to chronic pain populations on a numerical rating scale ranging from 0-10

  2. Computerized Cognitive Assessments - Balloon Analogue Risk Task [ Time Frame: 8 weeks ]
    Determine level of cognitive functioning

  3. Computerized Cognitive Assessments - Stroop Task [ Time Frame: 8 weeks ]
    Determine level of cognitive functioning

  4. Computerized Cognitive Assessments - Sternberg tasks [ Time Frame: 8 weeks ]
    Determine level of cognitive functioning

  5. Timed symbol digit substitution and copy [ Time Frame: 8 weeks ]
    Assessing attention/processing speed

  6. List learning-Rey Auditory Learning Test modified for visual presentation [ Time Frame: 8 weeks ]
    Immediate and delayed recall memory

  7. Figure Learning-Brief Visuospatial Memory Test - Revised [ Time Frame: 8 weeks ]
    Immediate and delayed recall memory; modified for self-administration

  8. Letter Series Test [ Time Frame: 8 weeks ]
    Assessment of executive functioning

  9. Positive and Negative Affect Scale [ Time Frame: 8 weeks ]
    Assessment of mood

  10. Visual Analog Scales [ Time Frame: 8 weeks ]
    Determine subjective performance aphasia

  11. Beck Depression Inventory Second Edition [ Time Frame: 8 weeks ]
    Depressive symptom assesment

  12. State Trait Anxiety Inventory [ Time Frame: 8 weeks ]
    Assessment of Anxiety symptoms

  13. Alcohol Use Disorders Identification Test [ Time Frame: 8 weeks ]
    Alcohol dependence and amount and frequency of alcohol use in past 6 months

  14. Alcohol Use Questionnaire [ Time Frame: 8 weeks ]
    Alcohol dependence and amount and frequency of alcohol use in past 6 months

  15. Daily Drinking Questionnaire [ Time Frame: 8 weeks ]
    Alcohol use in past 30 days

  16. Short inventory of problems [ Time Frame: 8 weeks ]
    Assessment of problems with drinking, binge drinking, cannabis and opioid use

  17. Cannabis use disorder identification test [ Time Frame: 8 weeks ]
    Assessment of problems with cannabis use

  18. Rapid Opioid Dependence Screen [ Time Frame: 8 weeks ]
    Assessment of problems with opioid use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General inclusion criteria:

  1. 18+ years,
  2. able to read and understand English,
  3. pain and insomnia complaints for 6+ months,
  4. diagnosed with (4.1) chronic pain and (4.2) insomnia based on the criteria below:

4.1a) Fibromyalgia: pain confirmed by tender point test (with application of 4 kg force, participant reports pain in 11+ of 18 points, including points in all four body quadrants),

4.1b) Chronic Widespread Pain: pain experienced in upper, lower body, on both sides and the back.

4.1c) Chronic Lower Back Pain: 1+ of following: chronic lower back pain without radiation below gluteal fold, with proximal radiation to knee, or with distal radiation below the knee.

4.2) insomnia complaints for 6+ months that:

4.2a) occur despite adequate opportunity and circumstances for sleep, and

4.2b) consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep,

4.2c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,

4.2d) baseline diaries indicate >30 minutes of sleep latency or wake after sleep onset combined on 6+ nights

Exclusion criteria:

  1. unable to provide informed consent,
  2. unable to complete forms and implement treatment due to cognitive impairment (MMSE<26),
  3. sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI>15], Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour > 15]),
  4. bipolar or seizure disorder (due to risk of sleep restriction treatment),
  5. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders),
  6. severe untreated psychiatric comorbidity,
  7. psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep,
  8. participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue or mood outside the current study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253691


Contacts
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Contact: Christina S McCrae, PhD 573-882-0982 mccraec@health.missouri.edu
Contact: Riley Stephens rlsmy9@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Publications:
Thompson, M., & Thompson, L. (2007). Neurofeedback for stress management. Principles and practice of stress management, 3, 249-287.
Tarrant, J., & Cope, H. (2018). Combining frontal gamma asymmetry neurofeedback with virtual reality: A proof-of-concept case study. NeuroRegulation, 5(2), 57-66. https://doi.org/10.15540/nr.5.2.57
Sutton, S. K., & Davidson, R. J. (1997). Prefrontal Brain Asymmetry: A Biological Substrate of the Behavioral Approach and Inhibition Systems. Psychological Science, 8(3), 204-210. https://doi.org/10.1111/j.1467-9280.1997.tb00413.x
Price, J., & Budzynski, T. (2009). Anxiety, EEG patterns, and neurofeedback. Introduction to quantitative EEG and neurofeedback: Advanced theory and applications, 453-470.

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Responsible Party: Christina McCrae, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04253691    
Other Study ID Numbers: 2017122
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina McCrae, University of Missouri-Columbia:
Sleep
Pain
Virtual Reality
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms