Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
- Conditions
- Pain, ChronicInsomnia Chronic
- Interventions
- Device: Virtual Reality Mediated Relaxation
- Registration Number
- NCT04253691
- Lead Sponsor
- 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).
- Detailed Description
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. Research has shown that Cognitive Behavioral Therapies (CBT) are efficacious in treating patient with comorbid insomnia and chronic pain (e.g., improvements in sleep parameters, normal sleep efficiency, reductions in pain severity. CBT addresses a number of factors involved in the maintenance of patient sleep and health issues, and a key piece of CBT for insomnia and pain is the reduction of worrisome thoughts, or anxiety related to sleep and pain issues. A common evidence-based strategy used for reducing anxiety and worry is the practice of relaxation. The aim of this study is to investigate the benefits of replacing treatment as usual (TAU) relaxation practices, with Virtual Reality (VR) mediation environments within CBT treatment.
Virtual Reality Meditation for Anxiety
There are few studies in the literature demonstrating a relationship between Virtual Reality (VR) - a computer generated environment that presents the user with a realistic three-dimensional space - and reductions in anxious symptomology. However, the results of those studies are very encouraging. In a case study, Tarrant and Cope treated 4 firefighters who had anxiety and anxiety-based disorders with a Positivity VR Experience. 3 of 4 treated patients exhibited increased left gamma symmetry, associated with approach behavior and increased mood, and 3 of 4 patients showed increases in State-Cheerfulness and Positive Affect. Tarrant and colleagues also conducted a pilot study, where they treated 14 patients who had moderate or higher levels of generalized anxiety with a 5-minute Mindfulness in Nature experience. Patients in the VR meditation group showed both global and regional decreases in Beta activity (i.e., decrease in frequencies associated with qualitatively anxious states and decreased self-reported State Anxiety. Overall, these results seem promising, as they provide preliminary evidence supporting that VR interventions may be a useful and effective tool for the treatment of elevated anxiety symptoms.
In summary, this clinical trial will examine the effects of VR meditation environments on patients with pain- and insomnia-related anxiety. The proposed study design will yield important information about the efficacy of VR meditation practices. 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.
Ultimately, this research targets two important public health concerns, namely insomnia and chronic pain. Insomnia in the context of chronic pain has been relatively understudied. Thus, the results of the present study will provide unique insights into sleep and chronic pain and will advance knowledge in the fields of both sleep and pain. Although the results of this study will be specific to chronic pain patients, they will have broader implications for other medical populations likely to suffer from chronic pain and insomnia (i.e., cancer patients, older adults). The information gained has the potential to make a significant contribution to behavioral healthcare practices for a wide variety of disorders, not just insomnia and pain. Thus, this research has implications not only for future sleep and pain research but also for other types of treatment-related research.
2. Objectives
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtual Reality Based Relaxation Therapy Virtual Reality Mediated Relaxation This is a pilot trial with one treatment condition (VR mediation).
- Primary Outcome Measures
Name Time Method Daily Electronic Sleep/Pain Diaries 6 weeks Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption
Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset) 6 weeks Objective wake after sleep onset
Fatigue Severity Scale 6 weeks Fatigue severity; min:10 max: 73; higher score means higher fatigue severity
Objective Daily Sleep Actiwatch-2 (Sleep Onset Latency) 6 weeks Objective sleep onset latency
Insomnia Severity Index 6 weeks Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Objective Daily Sleep Actiwatch-2 (Sleep Efficiency) 6 weeks Objective sleep efficiency
- Secondary Outcome Measures
Name Time Method Computerized Cognitive Assessments - Sternberg tasks 6 weeks Determine level of cognitive functioning
State Trait Anxiety Inventory 6 weeks Assessment of Anxiety symptoms; mix: 0 max:60; higher score means higher anxiety
Patient centered outcomes questionnaire 6 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; min: 0 max:200; 200; A greater score equates a worse outcome
Cognitive Failures Questionnaire 6 weeks Self-reported failures in perception, memory, and motor function; min:0 max: 100; higher score means greater cognitive failure
Computerized Cognitive Assessments -WCST 6 weeks Determine level of cognitive functioning
Computerized Cognitive Assessments - Stroop Task 6 weeks Determine level of cognitive functioning
List learning-Rey Auditory Learning Test modified for visual presentation 6 weeks Immediate and delayed recall memory
Beck Depression Inventory Second Edition 6 weeks Depressive symptom assessment; min: 0 max: 63; Higher score means higher severity of depression
Trial Locations
- Locations (1)
University of Missouri
🇺🇸Columbia, Missouri, United States