Sleep and Pain Intervention for Chronic Pain Using Virtual Reality Pilot Study
|ClinicalTrials.gov Identifier: NCT04253691|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
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:
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
- To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- PROMIS-57 Profile v2.0 parameters [ Time Frame: 8 weeks ]Fatigue, sleep, pain interference and intensity, anxiety and depression measurement
- McGill Pain Questionnaire [ Time Frame: 8 weeks ]Pain measurement
- Pain Disability Inventory [ Time Frame: 8 weeks ]Pain measurement
- Objective Daily Sleep Actiwatch-2 [ Time Frame: 8 weeks ]Sleep latency, wake after sleep onset and efficiency measurement
- Insomnia Severity Index [ Time Frame: 8 weeks ]Insomnia severity measurement
- 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
- Computerized Cognitive Assessments - Balloon Analogue Risk Task [ Time Frame: 8 weeks ]Determine level of cognitive functioning
- Computerized Cognitive Assessments - Stroop Task [ Time Frame: 8 weeks ]Determine level of cognitive functioning
- Computerized Cognitive Assessments - Sternberg tasks [ Time Frame: 8 weeks ]Determine level of cognitive functioning
- Timed symbol digit substitution and copy [ Time Frame: 8 weeks ]Assessing attention/processing speed
- List learning-Rey Auditory Learning Test modified for visual presentation [ Time Frame: 8 weeks ]Immediate and delayed recall memory
- Figure Learning-Brief Visuospatial Memory Test - Revised [ Time Frame: 8 weeks ]Immediate and delayed recall memory; modified for self-administration
- Letter Series Test [ Time Frame: 8 weeks ]Assessment of executive functioning
- Positive and Negative Affect Scale [ Time Frame: 8 weeks ]Assessment of mood
- Visual Analog Scales [ Time Frame: 8 weeks ]Determine subjective performance aphasia
- Beck Depression Inventory Second Edition [ Time Frame: 8 weeks ]Depressive symptom assesment
- State Trait Anxiety Inventory [ Time Frame: 8 weeks ]Assessment of Anxiety symptoms
- Alcohol Use Disorders Identification Test [ Time Frame: 8 weeks ]Alcohol dependence and amount and frequency of alcohol use in past 6 months
- Alcohol Use Questionnaire [ Time Frame: 8 weeks ]Alcohol dependence and amount and frequency of alcohol use in past 6 months
- Daily Drinking Questionnaire [ Time Frame: 8 weeks ]Alcohol use in past 30 days
- Short inventory of problems [ Time Frame: 8 weeks ]Assessment of problems with drinking, binge drinking, cannabis and opioid use
- Cannabis use disorder identification test [ Time Frame: 8 weeks ]Assessment of problems with cannabis use
- Rapid Opioid Dependence Screen [ Time Frame: 8 weeks ]Assessment of problems with opioid use
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253691
|Contact: Christina S McCrae, PhDemail@example.com|
|Contact: Riley Stephensfirstname.lastname@example.org|