A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action.

OBJECTIVE: The goal of this systematic review was to evaluate practice-based, real-world research of individualized complementary and integrative health (CIH) therapies for pain as provided in CIH outpatient clinics. METHODS: A systematic review was conducted on articles in PubMed, Ovid, Cochrane, Web of Science, Scopus, and Embase published through December 2020. The study was listed in the PROSPERO database (CRD42020159193). Major categories of variables extracted included study details and demographics, interventions, and outcomes. RESULTS: The literature search yielded 3,316 records, with 264 assessed for full-text review. Of those, 23 studies (including ∼8,464 patients) were specific to pain conditions as a main outcome. Studies included chiropractic, acupuncture, multimodal individualized intervention/programs, physiotherapy, and anthroposophic medicine therapy. Retention rates ranged from 53% to 91%, with studies offering monetary incentives showing the highest retention. The 0-10 numerical rating scale was the most common pain questionnaire (n = 10; 43% of studies), with an average percent improvement across all studies and time points of 32% (range: 18-60%). CONCLUSIONS: Findings from this systematic review of practice-based, real-word research indicate that CIH therapies exert positive effects on various pain outcomes. Although all studies reported beneficial impacts on one or more pain outcomes, the heterogeneous nature of the studies limits our overall understanding of CIH as provided in clinical settings. Accordingly, we present numerous recommendations to improve publication reporting and guide future research. Our call to action is that future practice-based CIH research is needed, but it should be more expansive and conducted in association with a CIH scientific society with academic and health care members.

Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines.

Background: Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported. Methods: ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity. Results: Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2-22), needle retention time (M = 23.5 min, range 4-52), session length (M = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form. Conclusion: To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs. Protocol registration: The protocol of this study is registered at clinicaltrials.gov: NCT04880733.

Evaluation of a Distance Reiki Program for Frontline Healthcare Workers' Health-Related Quality of Life During the COVID-19 Pandemic.

Background: Reiki is a biofield therapy which is based on the explanatory model that the fields of energy and information of living systems can be influenced to promote relaxation and stimulate a healing response. Objective: To conduct a pragmatic within-subject pilot trial of a remote Reiki program for frontline healthcare workers' health-related symptoms during the COVID-19 pandemic. Methods: Healthcare professionals in the UK (eg, physicians, nurses, and paramedics) were eligible to sign up for a distance Reiki program and were also invited to participate in the research study. Eight Reiki practitioners simultaneously gave each participant Reiki remotely for 20 minutes on 4 consecutive days. Feasibility of the research was assessed, including recruitment, data completeness, acceptability and intervention fidelity, and preliminary evaluation of changes in outcome measures. Participants' stress, anxiety, pain, wellbeing, and sleep quality were evaluated with 7-point numerical rating scales. Measures were completed when signing up to receive Reiki (pre) and following the final Reiki session (post). Pre and post data were analyzed using Wilcoxon signed ranks tests. Results: Seventy-nine healthcare professionals signed up to receive Reiki and took the baseline measures. Of those, 40 completed post-measures after the 4-day intervention and were therefore included in the pre-post analysis. Most participants were female (97.5%), and the mean age was 43.9 years old (standard deviations = 11.2). The study was feasible to conduct, with satisfactory recruitment, data completeness, acceptability, and fidelity. Wilcoxon signed ranks tests revealed statistically significant decreases in stress (M = -2.33; P < .001), anxiety (M = -2.79; P < .001) and pain (M = -.79; P < .001), and significant increases in wellbeing (M = -1.79; P < .001) and sleep quality (M = -1.33; P = .019). Conclusions: The Reiki program was feasible and was associated with decreased stress, anxiety and pain, and increased wellbeing and sleep quality in frontline healthcare workers impacted by the COVID-19 pandemic.

Assessment of Healthcare Professionals' Wellbeing During a Peak of the COVID-19 Pandemic in a Healthcare System in Ohio.

Objective: The purpose of this cross-sectional study was to evaluate multiple indices of wellbeing in healthcare professionals during the COVID-19 pandemic. Methods: Healthcare professionals were invited to participate across the University Hospitals healthcare system in Ohio, USA. Participants (N = 6397) completed online questionnaires on their wellbeing, including healthy behaviors, safety and security, mental and physical health concerns, and social support. Differences in wellbeing across demographics were also assessed. Results: Overall, healthcare professionals' mean subjective wellbeing was 7.98 (1.50) and their future health score was 3.98 (1.13). Room for improvement was noted for diet, sleep, and positive thinking. Males reported significantly higher levels of overall wellbeing and future health scores, including fruit and vegetable intake and physical activity, and alcohol use, whereas females reported higher levels of positive thinking and tobacco use. Of the three largest racial groups, White and Asian employees scored significantly higher on future health, M = 4.00 (1.17) and M = 4.10 (1.13), than Black or African American employees, M = 3.74 (1.10). Conclusions: This cross-sectional study assessed the wellbeing of healthcare workers during the initial peak of the COVID-19 pandemic prior to vaccine delivery. Future work will implement strategies to improve healthcare workers' wellbeing in an individualized way based on our findings, as well as evaluate changes in wellbeing and future health scores across time.

An Evaluation of the Subjective Experience of Receiving Reiki: Qualitative Results from a Pragmatic Effectiveness Study.

Objectives: The main purpose of this study was to evaluate the subjective experience of Reiki in a large sample. Design: The study design was a single-arm pragmatic effectiveness trial with qualitative questions completed post-Reiki session. Setting: The study took place at private Reiki practices across the United States. Subjects: A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners invited each of their Reiki clients to complete a survey before and after the Reiki session. Of the N = 1575 Reiki sessions recorded, N = 1284 qualitative responses were completed (82% of total) and included in the analysis. Interventions: Trained and experienced Reiki masters conducted Reiki sessions in person, with each session lasting between 45 and 90 min. Outcome measures: Participants were asked to describe their experience during the Reiki session. Results: Qualitative analysis revealed eight major themes: (1) deep relaxation and calm (68%), (2) body sensations/somatic experiences (53%), (3) emotions (29%), (4) spiritual or symbolic significance (18%), (5) changes in symptoms (17%), (6) changes in perception (11%), (7) sleep and drowsiness (10%), and (8) changes to breathing (4%). Significantly more males reported feeling relaxed and experiencing time perception changes, whereas more females reported body sensations, emotions, visual perceptions, and spiritual significance. Conclusions: The findings from this study suggest that Reiki can elicit the relaxation response and alter emotions and perception in such a way as to facilitate a transformative subjective healing experience. Future work will analyze these themes as they relate to changes in symptoms and compare the experience of Reiki with other biofield therapies.

"Making it okay": professionals in high-stress environments construct their understanding of the impact of a yoga-based retreat designed to build resilience.

PURPOSE: While there is growing evidence for resilience building programmes, to date research has not explored how professionals construct understanding of programme impact. RISE (resilience, integration, self-awareness, engagement), a 5-day yoga-based retreat programme, has been linked with positive wellness outcomes. This qualitative inquiry explores participants' reflection and experience 3 months after programme completion. METHODS: Through a grounded constructivist lens, in-depth semi-structured phone interviews were conducted with 17 adult professionals in high-stress work environments who attended RISE. Initial hand-coding informed codebook development for systematic coding using directed content analysis using sensitizing structuring. RESULTS: Two integrated perceptions woven through five themes. Persistent threads of experiential learning and sense of permission provided structure for themes found. Five interrelated themes related to psychological health and workplace dynamics were (1) use of acquired behavioural skills and practices; (2) lived mindfulness; (3) resilience to stress and emotion regulation (4) self-care and self-compassion, and (5) sharing with others. CONCLUSION: Findings provide meaningful interpretation of previously reported programme efficacy by contextualizing perceived benefits within participants' constructed understanding of change. Specifically, environmental, social, and experiential considerations have suggested implications for resilience building programmes.Abbreviations: RISE (resilience, integration, self-awareness, engagement).

The Impact of Individualized Complementary and Integrative Health Interventions Provided in Clinical Settings on Quality of Life: A Systematic Review of Practice-Based Research.

Background: The goal of this systematic review was to evaluate the impact of individualized complementary and integrative health (CIH) interventions on quality-of-life outcomes as collected in CIH outpatient clinics. Methods: A systematic review was conducted using PubMed, OVID, Cochrane, Web of Science, Scopus, and Embase through December 2020. Inclusion criteria were as follows: individualized CIH treatment, longitudinal effectiveness design, patient-reported outcomes, outpatient CIH clinic setting, participants aged ≥18 years, sample size of ≥25, and English full text. The study was listed in the PROSPERO database (CRD42020159193), and PRISMA guidelines were used. The variables extracted from articles focused on study details/demographics, CIH intervention characteristics, and outcome characteristics. Results: The literature search yielded 3316 records with 264 assessed for full-text review. Of these, 19 studies (including ∼14,002 patients) were specific to quality of life (or well-being) as a main outcome. Most studies included were multidisciplinary studies (n = 12), followed by acupuncture (n = 4), chiropractic (n = 3), and massage or reflexology (n = 1). The short-form group of questionnaires (SF-12, SF-36, SF-8) were the most used quality-of-life/well-being questionnaire, comprising 37% of studies (n = 7), and the Patient Reported Outcomes Measurement Information System (PROMIS) measures comprised 21% (n = 4). Both questionnaires are normed to U.S. population, allowing for comparison. The average improvement across the comparable SF and PROMIS measures for Physical Health was 6% (range 2%-20%) and for Mental Health was 5% (range 1%-11%), demonstrating clinical significance. Improvements in the observational studies are comparable to improvements reported from randomized controlled trials. Conclusions: Results from this systematic review indicate that CIH therapies largely have positive effects on health-related quality of life and well-being for various patient populations seen in CIH clinical settings. Direct comparisons across studies were limited due to the variability in study design and incomplete reporting in some of the publications. Suggestions for improving the design and reporting for future practice-based research are provided.

Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: Outcomes of the PRIMIER cohort.

OBJECTIVE: To evaluate the real-world effectiveness of integrative medicine treatment on quality of life using the Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER). DESIGN: A prospective, longitudinal, observational evaluation of patient reported outcomes for quality of life. SETTING: Participants were patients from 17 integrative medicine clinics who received personalized, integrative medicine treatments between August 2013 and October 2017. MAIN OUTCOME MEASURES: Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS)- 29, Perceived Stress Scale-4 (PSS-4), and the Patient Activation Measure (PAM) at index (baseline) visit and at 2, 4, 6, and 12 month follow-up assessments. Electronic health record data included diagnostic and billing codes/descriptions. A linear mixed-effects model was used to test whether outcomes changed from index through 12 months RESULTS: During enrollment, 4883 participants began the assessment, 3658 completed the index measures, and 2374 (65 %) completed at least 1 follow-up assessment, had electronic health record data and at least 1 integrative medicine visit. Most participants (mean age=51.4 years) were white (88.4 %), female (79.7 %), and college-educated (78.5 %). Significant improvements (p < 0.001) were observed at 12-months on all PROMIS-29 measures, PSS-4, and PAM. At 12 months, clinically meaningful improvements were found for 38 % and 28 % on PROMIS-29 Mental and Physical Health Summary scores respectively. CONCLUSIONS: PRIMIER is the largest study to assess the real-world effectiveness of integrative medicine. Results indicate a statistical and clinical improvement across all measures at 12 months. Future research could explore whether dosing, timing or combinations of integrative medicine interventions have differential impacts on quality of life.

A 3-Day residential yoga-based program improves education professionals' psychological and occupational health in a single arm trial.

OBJECTIVE: This study examined changes in psychological and occupational health in urban education professionals after attending a brief yoga-based program. METHODS: Education professionals from the New York City Department of Education (NYC DOE) who were attending a residential 3-day yoga-based program at Kripalu Center for Yoga & Health were recruited to participate in the study. Measures of psychological and occupational health and health-related behaviors were completed before (baseline), after (post), and two months after the program (follow-up). Paired samples t-tests were used to compare scores between time points. RESULTS: At post, participants (N = 74) showed improvements in stress, resilience, affect, mindfulness, empowerment, self-compassion, satisfaction with life, work engagement, burnout, exercise, and vegetable intake (all p values < 0.05) compared to baseline. At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline. There were significant correlations between the degree of home practice of the skills and techniques learned in the program and improvements in multiple measures of psychological and occupational health at follow-up (all p values < 0.05). CONCLUSIONS: These findings suggest that the yoga-based program improves psychological and occupational health and healthy behaviors in education professionals immediately following the program and up to two-months following the program, however, more data with larger sample sizes are needed to confirm sustained benefits over the longer term.

Evaluation of a Yoga-Based Mind-Body Intervention for Resident Physicians: A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVE: Mind-body interventions (MBIs) have been shown to be effective individual-level interventions for mitigating physician burnout, but there are no controlled studies of yoga-based MBIs in resident physicians. We assessed the feasibility of a yoga-based MBI called RISE (resilience, integration, self-awareness, engagement) for residents among multiple specialties and academic medical centers. METHODS: We conducted a waitlist controlled randomized clinical trial of the RISE program with residents from multiple specialty departments at three academic medical centers. The RISE program consisted of six weekly sessions with suggested home practice. Feasibility was assessed across six domains: demand, implementation, practicality, acceptability, adaptation, and integration. Self-reported measures of psychological health were collected at baseline, post-program, and two-month follow-up. RESULTS: Among 2,000 residents contacted, 75 were assessed for eligibility and 56 were enrolled. Forty-four participants completed the study and were included in analysis. On average, participants attended two of six sessions. Feasibility of in-person attendance was rated as 28.9 (SD 25.6) on a 100-point visual analogue scale. Participants rated feasibility as 69.2 (SD 26.0) if the program was offered virtually. Those who received RISE reported improvements in mindfulness, stress, burnout, and physician well-being from baseline to post-program, which were sustained at two-month follow-up. CONCLUSION: This is the first controlled study of a yoga-based MBI in residents. While the program was not feasible as delivered in this pilot study, initial analyses showed improvement in multiple measures of psychological health. Residents reported that virtual delivery would increase feasibility.

A Yoga-Based Program Decreases Physician Burnout in Neonatologists and Obstetricians at an Academic Medical Center.

BACKGROUND: Nearly half of U.S. pediatricians have symptoms of burnout. This pilot study examined the feasibility of a 6-week yoga-based program (RISE) for neonatologists and obstetricians at Brigham and Women's Hospital and studied the effects on burnout, professional fulfillment, and psychological health. METHODS: Participants were recruited via email to participate either in both program and research study, or exclusively the program. RISE was delivered 1 hour/week during the workday for 6 consecutive weeks either in-person or remotely; 18 physicians participated, 12 completed post-program, and 11 completed 2-month follow-up. The questionnaires assessed burnout and measures of psychological health, professional fulfillment, work exhaustion, interpersonal disengagement/burnout (PFI), mindfulness (FFMQ), perceived stress (PSS), positive/negative affect (PANAS), resilience (RS), anxiety/depression/sleep disturbances (PROMIS), at baseline, post-program, and 2 months after RISE. FINDINGS: Average attendance in-person was 2.8 sessions and remotely 1.4 sessions (4.2/6 sessions). Participants demonstrating total burnout reduced from 50.0% at baseline to 9.1% post-program. Participants demonstrating professional fulfillment were 8.3% at baseline and 27.3% post-program. Paired samples t-tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline (N = 12, all ps < .05). At 2-month follow-up, statistically significant improvements in interpersonal disengagement, resilience, and mindfulness (N = 11, all ps < .05) compared with baseline were reported. CONCLUSIONS/APPLICATION TO PRACTICE: RISE is feasible within a workday and may address burnout and other psychological health measures in physicians with effects potentially sustainable over 2 months. Occupational health practitioners in health care should consider this type of intervention for their workers.

A Pragmatic Controlled Trial of a Brief Yoga and Mindfulness-Based Program for Psychological and Occupational Health in Education Professionals.

OBJECTIVES: To examine changes in psychological and occupational wellbeing in education professionals that attended a brief yoga and mindfulness-based program. DESIGN: Pragmatic controlled trial comparing education professionals that attended a yoga mindfulness-based program (n = 9) to a waitlist control group (n = 22). SETTING: The 3-day program was delivered at the Kripalu Center for Yoga & Health in Massachusetts. INTERVENTION: The 3-day yoga mindfulness program included 5 hours per day of yoga, mindfulness exercises, formal meditation, didactic, and experiential activities. MAIN OUTCOME MEASURES: Measures of psychological and occupational wellbeing were completed before (baseline), immediately after (post-program), and two months after the program (follow-up). RESULTS: Relative to controls (n = 21), the RISE group (n = 9) showed significant improvements in positive affect (p = .033), negative affect (p = .044), mindfulness (p = .001), empowerment (p = .022), self-compassion (p = .001), and work engagement from baseline to post-program. From baseline to follow-up, the RISE group showed significant improvements in stress (p = .008), negative affect (p = .013), mindfulness (p = .001), empowerment (p = .007), and self-compassion (p = .001) compared to the control group. CONCLUSIONS: The yoga mindfulness program was associated with improvements in educators' psychological and occupational wellbeing immediately following and 2-months following the program. Future research with a larger sample size is needed to confirm these results.

A Large-Scale Effectiveness Trial of Reiki for Physical and Psychological Health.

Objectives: The main purpose of this study was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample. Design: The study design was a single arm effectiveness trial with measures at pre-and postintervention. Settings: The study took place at private Reiki practices across the United States. Subjects: Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session. Interventions: Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. Outcome measures: The well-validated 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session. Results: A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001). Conclusions: The results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.