Chronic Pain Clinical Trial
Official title:
Pilot Study to Evaluate Virtual Reality for Pain Management in Advanced Heart Failure
NCT number | NCT04572425 |
Other study ID # | 2018-076 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | March 30, 2020 |
Verified date | September 2020 |
Source | Medstar Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating heart failure pain in hospitalized patients with heart failure and compare this impact to that of 2-dimensional guided imagery distraction therapy.
Status | Completed |
Enrollment | 94 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - hospitalized at study institution - primary diagnosis of ACC/AHA Stage C or D heart failure - reports pain on 0-10 Likert scale at least 4/10 or greater Exclusion Criteria (any of the following): - participant already uses virtual reality for personal use - intractable nausea/vomiting - history of motion sickness - history of seizures or epilepsy - have cranial structure abnormalities that prevent use of VR headset - currently enrolled in a palliative care or pain management study - on contact isolation |
Country | Name | City | State |
---|---|---|---|
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Medstar Health Research Institute |
United States,
Stewart D, Mete M, Groninger H. Virtual reality for pain management in patients with heart failure: Study rationale and design. Contemp Clin Trials Commun. 2019 Oct 12;16:100470. doi: 10.1016/j.conctc.2019.100470. eCollection 2019 Dec. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self reported pain score | Likert scale 0 (no pain) to 10 (worst pain) | Immediately after assigned intervention | |
Secondary | Quality of life score | Functional Assessment in Chronic Illness-Therapy in Palliative Care 14-item scale (FACIT Pal 14 scale) -- subject replies to 14 questions about quality of life issues with responses in 5-point Likert scale (0 = not at all; 4 = very much), total score range 0-56 | Immediately after assigned intervention | |
Secondary | Self reported distress | National Comprehensive Cancer Network Distress Thermometer -- subject rates distress at that point in time on Likert scale 0-10 (0 = no distress; 10 = worst distress) | Immediately after assigned intervention | |
Secondary | Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study | Single best answer to this question: subjects choose between "easy," "normal," or "difficult" | Immediately after assigned intervention | |
Secondary | Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study | Single best answer: subjects choose between two choices, "Yes" or "No" | Immediately after assigned intervention |
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