A pilot randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol.

BACKGROUND: Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive problems, insomnia, anxiety, and depression. There is currently no cure for long COVID, and the average length of recovery and proportion of patients who fully recover are still unknown. Subsequently, there is a critical need to improve function. Research in other chronic conditions suggests that psychosocial self-management interventions reduce symptom severity and interference with functioning. We describe the design of our study to examine the feasibility, acceptability, appropriateness, and preliminary efficacy of an intervention designed to improve symptom management and coping in adults with long COVID. METHODS: This pilot trial (N = 50) uses a pragmatic, randomized two-group parallel design set within the University of Washington Post-COVID Rehabilitation and Recovery Clinic. The self-management intervention is a 6-week, group-based telemedicine intervention that teaches evidence-based strategies to manage common symptoms and improve stress management as well as communication and self-advocacy. The comparator is a wait-list control. Participants complete self-report measures of the primary and secondary outcomes at baseline and post-treatment/wait-list. Primary outcomes include intervention feasibility, acceptability, and appropriateness. Secondary outcomes include Patient-Reported Outcomes Measurement Information System measures of fatigue, sleep disturbance, cognitive difficulties, self-efficacy, pain interference, depression and anxiety symptoms, and a measure of long COVID symptoms and impression of change. At post-intervention, intervention participants also complete a qualitative interview to inform intervention refinement. Quantitative data will be examined using descriptive and statistical analysis including t-tests and chi-square tests to compare the intervention and wait-list groups on secondary outcomes. Qualitative data will be analyzed using the rigorous and accelerated data reduction technique (RADaR). DISCUSSION: Results of this pilot randomized controlled trial will characterize the feasibility, acceptability, and appropriateness of the self-management intervention and inform intervention refinement necessary prior to further testing. Long COVID is a public health concern, and rehabilitation approaches that equip patients to manage symptoms may improve patient function and quality of life and reduce burden on the health care system. TRIAL REGISTRATION: NCT05658536. December 16, 2022.

The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial.

BACKGROUND: Chronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP. METHODS: This is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported. RESULTS: Medium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d = - .49). CONCLUSIONS: The findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03687762.

A comparison of interactive immersive virtual reality and still nature pictures as distraction-based analgesia in burn wound care.

PURPOSE: Non-pharmacologic adjuncts to opioid analgesics for burn wound debridement enhance safety and cost effectiveness in care. The current study explored the feasibility of using a custom portable water-friendly immersive VR hardware during burn debridement in adults, and tested whether interactive VR would reduce pain more effectively than nature stimuli viewed in the same VR goggles. METHODS: Forty-eight patients with severe burn injuries (44 adults and 4 children) had their burn injuries debrided and dressed in a wet wound care environment on Study Day 1, and 13 also participated in Study Day 2. INTERVENTION: The study used a within-subject design to test two hypotheses (one hypothesis per study day) with the condition order randomized. On Study Day 1, each individual (n = 44 participants) spent 5 min of wound care in an interactive immersive VR environment designed for burn care, and 5 min looking at still nature photos and sounds of nature in the same VR goggles. On Study Day 2 (n = 12 adult participants and one adolescent from Day 1), each participant spent 5 min of burn wound care with no distraction and 5 min of wound care in VR, using a new water-friendly VR system. On both days, during a post-wound care assessment, participants rated and compared the pain they had experienced in each condition. OUTCOME MEASURES ON STUDY DAYS 1 AND 2: Worst pain during burn wound care was the primary dependent variable. Secondary measures were ratings of time spent thinking about pain during wound care, pain unpleasantness, and positive affect during wound care. RESULTS: On Study Day 1, no significant differences in worst pain ratings during wound care were found between the computer-generated world (Mean = 71.06, SD = 26.86) vs. Nature pictures conditions (Mean = 68.19, SD = 29.26; t < 1, NS). On secondary measures, positive affect (fun) was higher, and realism was lower during computer-generated VR. No significant differences in pain unpleasantness or "presence in VR" between the two conditions were found, however. VR VS. NO VR. (STUDY DAY 2): Participants reported significantly less worst pain when distracted with adjunctive computer generated VR than during standard wound care without distraction (Mean = 54.23, SD = 26.13 vs 63.85, SD = 31.50, t(11) = 1.91, p < .05, SD = 17.38). In addition, on Study Day 2, "time spent thinking about pain during wound care" was significantly less during the VR condition, and positive affect was significantly greater during VR, compared to the No VR condition. CONCLUSION: The current study is innovative in that it is the first to show the feasibility of using a custom portable water-friendly immersive VR hardware during burn debridement in adults. However, contrary to predictions, interactive VR did not reduce pain more effectively than nature stimuli viewed in the same VR goggles.

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study.

Immersive virtual reality is proving effective as a non-pharmacologic analgesic for a growing number of painful medical procedures. External fixator surgical pins provide adjunctive stability to a broken pelvic bone until the bones heal back together, then pins are removed. The purpose of the present case study was to measure for the first time, whether immersive virtual reality could be used to help reduce pain and anxiety during the orthopedic process of removing external fixator pins from a conscious patient in the orthopedic outpatient clinic, and whether it is feasible to use VR in this context. Using a within-subject within wound care design with treatment order randomized, the patient had his first ex-fix pin unscrewed and removed from his healing pelvic bone while he wore a VR helmet and explored an immersive snowy 3D computer generated world, adjunctive VR. He then had his second pin removed during no VR, standard of care pain medications. The patient reported having 43% less pain intensity, 67% less time spent thinking about pain, and 43% lower anxiety during VR vs. during No VR. In addition, the patient reported that his satisfaction with pain management was improved with the use of VR. Conducting simple orthopedic procedures using oral pain pills in an outpatient setting instead of anesthesia in the operating room greatly reduces the amount of opioids used, lowers medical costs and reduces rare but real risks of expensive complications from anesthesia including oversedation, death, and post-surgical dementia. These preliminary results suggest that immersive VR merits more attention as a potentially viable adjunctive non-pharmacologic form of treatment for acute pain and anxiety during medical procedures in the orthopedic outpatient clinic. Recent multi-billion dollar investments into R and D and mass production have made inexpensive immersive virtual reality products commercially available and cost effective for medical applications. We speculate that in the future, patients may be more willing to have minor surgery procedures in the outpatient clinic, with much lower opioid doses, while fully awake, if offered adjunctive virtual reality as a non-pharmacologic analgesic during the procedure. Additional research and development is recommended.

Virtual reality analgesia for burn joint flexibility: A randomized controlled trial.

OBJECTIVE: We conducted a randomized controlled study to determine the effects of virtual reality (VR) distraction on pain and range of motion (ROM) in patients hospitalized for burn care during active physical therapy exercises. METHOD: Thirty-nine participants aged 15 to 66 (M = 36) years with significant burn injuries (mean burn size = 14% TBSA) participated. Under therapist supervision, using a within-subjects design, participants performed unassisted active ROM exercises both with and without VR distraction in a randomized order. Therapists provided participants with instructions but did not physically assist with stretches. Maximum active ROM was measured using a goniometer. A 0-100 Graphic Rating Scale (GRS) was used to assess the cognitive, affective, and sensory components of pain. A GRS rating of the amount of "fun" during stretching served as a measure of positive experience. RESULTS: Participants reported lower mean GRS ratings during VR, relative to No VR, for worst pain, pain unpleasantness, and time spent thinking about pain. They also reported having a more positive experience during VR than during No VR. However, patients did not show greater ROM during VR. CONCLUSION: Immersive VR reduced pain during ROM exercises that were under the control of the patient. (PsycINFO Database Record (c) 2018 APA, all rights reserved).