NCT04253691

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2020Dec 2026

First Submitted

Initial submission to the registry

January 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 9, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

January 16, 2020

Last Update Submit

April 21, 2026

Conditions

Insomnia ChronicPain, Chronic

Keywords

SleepPainVirtual Reality

Outcome Measures

Primary Outcomes (6)

  • Daily Electronic Sleep/Pain Diaries

    Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption

    6 weeks

  • Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset)

    Objective wake after sleep onset

    6 weeks

  • Objective Daily Sleep Actiwatch-2 (Sleep Onset Latency)

    Objective sleep onset latency

    6 weeks

  • Objective Daily Sleep Actiwatch-2 (Sleep Efficiency)

    Objective sleep efficiency

    6 weeks

  • Insomnia Severity Index

    Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity

    6 weeks

  • Fatigue Severity Scale

    Fatigue severity; min:10 max: 73; higher score means higher fatigue severity

    6 weeks

Secondary Outcomes (8)

  • Patient centered outcomes questionnaire

    6 weeks

  • Computerized Cognitive Assessments -WCST

    6 weeks

  • Computerized Cognitive Assessments - Stroop Task

    6 weeks

  • Computerized Cognitive Assessments - Sternberg tasks

    6 weeks

  • List learning-Rey Auditory Learning Test modified for visual presentation

    6 weeks

  • +3 more secondary outcomes

Study Arms (1)

Virtual Reality Based Relaxation Therapy

EXPERIMENTAL

This is a pilot trial with one treatment condition (VR mediation).

Device: Virtual Reality Mediated Relaxation

Interventions

Virtual Reality Mediated RelaxationDEVICE

Participants will use a brief Virtual Reality relaxation protocol to improve their insomnia. 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.

Virtual Reality Based Relaxation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years,
  • able to read and understand English,
  • pain and insomnia complaints for 6+ months,
  • diagnosed with (4.1) insomnia based on the criteria below:
  • ) insomnia complaints for 6+ months that:
  • a) occur despite adequate opportunity and circumstances for sleep, and
  • b) consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep,
  • c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,
  • d) screening ISI score ≥ 11

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (5)

  • Tarrant J, Viczko J, Cope H. Virtual Reality for Anxiety Reduction Demonstrated by Quantitative EEG: A Pilot Study. Front Psychol. 2018 Jul 24;9:1280. doi: 10.3389/fpsyg.2018.01280. eCollection 2018.

    PMID: 30087642BACKGROUND

  • Thompson, M., & Thompson, L. (2007). Neurofeedback for stress management. Principles and practice of stress management, 3, 249-287.

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • Price, J., & Budzynski, T. (2009). Anxiety, EEG patterns, and neurofeedback. Introduction to quantitative EEG and neurofeedback: Advanced theory and applications, 453-470.

    BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic PainPain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 5, 2020

Study Start

February 9, 2020

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)