The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature.

A systematic review was conducted using Samueli Institute's Rapid Evidence Assessment of the Literature (REAL) process to determine the evidence base for melatonin as an agent to optimize sleep or improve sleep quality, and generalize the results to a military, civilian, or other healthy, active, adult population. Multiple databases were searched yielding 35 randomized controlled trials (RCTs) meeting the review's inclusion criteria, which were assessed for methodological quality as well as for melatonin effectiveness. The majority of included studies were high quality (83.0%). Overall, according to Grading Recommendations, Assessment Development and Evaluation (GRADE) methodology, weak recommendations were made for preventing phase shifts from jet lag, for improving insomnia in both healthy volunteers and individuals with a history of insomnia, and for initiating sleep and/or improving sleep efficacy. Based on the literature to date, no recommendations for use in shift workers or to improve hormonal phase shift changes in healthy people can be made at this time. Larger and longer-duration RCTs utilizing well characterized products are needed to warrant melatonin recommendations in young, healthy adults.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, eg, External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONsolidated Standards of Reporting Trials (CONSORT) 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Measures of empathy and compassion: A scoping review.

Evidence to date indicates that compassion and empathy are health-enhancing qualities. Research points to interventions and practices involving compassion and empathy being beneficial, as well as being salient outcomes of contemplative practices such as mindfulness. Advancing the science of compassion and empathy requires that we select measures best suited to evaluating effectiveness of training and answering research questions. The objective of this scoping review was to 1) determine what instruments are currently available for measuring empathy and compassion, 2) assess how and to what extent they have been validated, and 3) provide an online tool to assist researchers and program evaluators in selecting appropriate measures for their settings and populations. A scoping review and broad evidence map were employed to systematically search and present an overview of the large and diverse body of literature pertaining to measuring compassion and empathy. A search string yielded 19,446 articles, and screening resulted in 559 measure development or validation articles reporting on 503 measures focusing on or containing subscales designed to measure empathy and/or compassion. For each measure, we identified the type of measure, construct being measured, in what context or population it was validated, response set, sample items, and how many different types of psychometrics had been assessed for that measure. We provide tables summarizing these data, as well as an open-source online interactive data visualization allowing viewers to search for measures of empathy and compassion, review their basic qualities, and access original citations containing more detail. Finally, we provide a rubric to help readers determine which measure(s) might best fit their context.

Patient experiences and outcomes in a virtual healing setting: A feasibility study.

RESEARCH QUESTIONS: How do participants with anxiety receiving distance healing using tuning forks, experience healing sessions? What outcomes do they spontaneously report? THEORETICAL FRAMEWORK: Modified grounded theory, using single interviews to learn about experiences with distant sound healing. METHODOLOGY: Standardized open-ended, qualitative interviews of 30-minute length were conducted after the intervention and analyzed using an inductive and iterative process for identifying themes, categories, and patterns in qualitative data. CONTEXT: Single-arm, pilot feasibility study of Biofield Tuning (BT) for anxiety during the COVID-19 pandemic delivered at a distance facilitated by Zoom (without video). SAMPLE SELECTION: A total of 15 participants were recruited to this study: 13 completed all quantitative aspects, and the 12 who completed the interviews are reported here. DATA COLLECTION: The 30-minute qualitative interviews were designed to understand the impact of virtual BT sessions on the participant's experience, anxiety, and within the larger context of their life. The Self-Assessment of Change measured subjective shifts pre and post treatment. ANALYSIS AND INTERPRETATION: The interviews were audio-recorded and transcribed using otter.ai. Two researchers read all the transcripts, identified key themes within the broader experience of sessions and outcomes categories, and came to consensus on key themes using a qualitative research analysis approach. MAIN RESULTS: Participants were surprised by the degree to which they felt sensations and heard tuning fork changes. They commented on the accuracy of the healers' perceptions and comprehension of their life experiences. Participants reported positive shifts in perceptions of themselves and their surroundings, both interpersonally and in response to triggers. The patients' own words provide insight into the lived experiences of healing, and guide future research.

Sound healing reduces generalized anxiety during the pandemic: A feasibility study.

OBJECTIVES: This study examined the feasibility and effectiveness of a virtually-delivered, biofield-based sound healing treatment to reduce anxiety for individuals meeting criteria for Generalized Anxiety Disorder. DESIGN: This one-group, mixed-method feasibility study was conducted virtually via Zoom during the SARS-CoV-2 Pandemic. Fifteen participants with moderate to high levels of anxiety as determined by the Generalized Anxiety Disorder-7 (≥10), were enrolled. INTERVENTION: Five certified Biofield Tuning Practitioners performed the interventions. Participants were given three weekly, hour-long sound healing treatments virtually, over a month's period. OUTCOME MEASURES: Attrition rates and reports on feasibility of intervention delivery and outcomes assessment were obtained by participants. Data on anxiety, positive and negative affect, spiritual experience, perceived stress, and quality of life were obtained via validated surveys and analyzed via repeated-measures analysis of variance with intention-to-treat. Linguistic inquiry and word count was utilized to assess changes in affective processing as reflected in participants' spoken words over the course of the intervention. Qualitative interviews were conducted to further determine tolerability and experiences with receiving BT that may not have been captured by survey and language data. RESULTS: Attrition rates were 13.3%, with two participants dropping out of the study after one session. The remaining participants reported acceptability of the data collection process and intervention delivery. Intention to treat analyses revealed statistically significant reductions in anxiety (State-Trait Anxiety Inventory), negative affect (Positive and Negative Affect Scale), and perceived stress (Perceived Stress Scale) (p < .001 in all cases). Linguistic and word count analysis revealed a significant linear decrease (p = .01) of participants' use of negative affect words over the course of the intervention. Qualitative data results are reported in another paper. CONCLUSIONS: Results indicate that BT delivered virtually is feasible and amenable to study, and that the impact of BT may be substantial in reducing anxiety and improving mental health. This is the first study of its kind to report clinically significant reductions in anxiety levels in response to a virtually-delivered, biofield-based sound therapy. Data will be used to power a randomized controlled trial to more deeply examine the effects of BT on whole-person healing for those suffering from anxiety.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

BACKGROUND: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. OBJECTIVES: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. STUDY DESIGN/METHODS: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. RESULTS: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. CONCLUSIONS: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

Barriers to the Entry of Biofield Healing Into "Mainstream" Healthcare.

In this article, we describe barriers to the entry of biofield healing into mainstream contemporary science and clinical practice. We focus on obstacles that arise from the social nature of the scientific enterprise, an aspect of science highlighted by the influential work of Thomas Kuhn (1922-1996), one of the most important- and controversial-philosophers of science in the 20th century. Kuhn analyzed science and its revolutionary changes in terms of the dynamics within scientific communities. Kuhn's approach helps us understand unconventional medical theories and practices such as biofield healing. For many years, these were called "complementary and alternative medicine" (CAM). However, because most people use nonmainstream approaches in conjunction with conventional treatments, the National Institutes of Health and many practitioners now prefer "Complementary and Integrative Medicine" (CIM) where integrative implies "bringing conventional and complementary approaches together in a coordinated way."(1) Biofield healing fits the integrative model well, provides a novel approach to therapeutic intervention, and is developing in a manner that can integrate with current medical science in simple ways. Yet, it still remains outside the conventional framework because of its conceptual bases, which contrast sharply with conventional assumptions regarding the nature of reality.

The effectiveness of acupuncture research across components of the trauma spectrum response (tsr): a systematic review of reviews.

BACKGROUND: Co-morbid symptoms (for example, chronic pain, depression, anxiety, and fatigue) are particularly common in military fighters returning from the current conflicts, who have experienced physical and/or psychological trauma. These overlapping conditions cut across the boundaries of mind, brain and body, resulting in a common symptomatic and functional spectrum of physical, cognitive, psychological and behavioral effects referred to as the 'Trauma Spectrum Response' (TSR). While acupuncture has been shown to treat some of these components effectively, the current literature is often difficult to interpret, inconsistent or of variable quality. Thus, to gauge comprehensively the effectiveness of acupuncture across TSR components, a systematic review of reviews was conducted using the Samueli Institute's Rapid Evidence Assessment of the Literature (REAL©) methodology. METHODS: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, EMBASE, CINAHL, and PsycInfo were searched from inception to September 2011 for systematic reviews/meta-analyses. Quality assessment was rigorously performed using the Scottish Intercollegiate Guidelines Network (SIGN 50) checklist and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. Adherence to the Standards for Reporting Interventions in Clinical Trials in Acupuncture (STRICTA) criteria was also assessed. RESULTS: Of the 1,480 citations identified by our searches, 52 systematic reviews/meta-analyses, all high quality except for one, met inclusion criteria for each TSR component except post-traumatic stress disorder (PTSD) and sexual function. The majority of reviews addressed most STRICTA components, but did not describe safety. CONCLUSIONS: Based on the results of our review, acupuncture appears to be effective for treating headaches and, although more research is needed, seems to be a promising treatment option for anxiety, sleep disturbances, depression and chronic pain. It does not, however, demonstrate any substantial treatment benefit for substance abuse. Because there were no reviews on PTSD or sexual function that met our pre-defined inclusion criteria, we cannot comment on acupuncture's effectiveness in treating these conditions. More quality data are also needed to determine whether acupuncture is appropriate for treating fatigue or cognitive difficulties. Further, while acupuncture has been shown to be generally safe, safety was not described in the majority of studies, making it difficult to provide any strong recommendations. Future research should address safety reporting in detail in order to increase our confidence in acupuncture's efficacy across the identified TSR components.