COVID-19 Pandemic Effects on the Activity Levels of Yucatan Mini-Swine (Sus scrofa domesticus).

During the COVID-19 pandemic, unexpected activity patterns emerged among Yucatan mini-swine models for heart failure and atrial fibrillation. As part of our laboratory research, we tracked activity data by FitBark™ collars that the Yucatan mini-swine wore. Previously, staff engaged with the swine daily, such as applying lotion and conducting 6-min treadmill runs. However, pandemic restrictions reduced interaction to 1 or 2 times a week, often for less than 10 min each session. Contrary to expectations, there was a significant increase in the swine's activity levels during these minimal interaction periods. After cleaning, moisturizing, weighing, and FitBark data collection, staff engaged with the swine through feeding and play. Three time frames were analyzed: prepandemic, pandemic, and reentry. Prepandemic and reentry periods involved daily 15-min interactions with 2 staff members per swine to maintain cleanliness and health. During the pandemic, interaction was reduced to 1 or 2 times weekly. The hours between 1000 and 1400 were designated as 'passive activity', representing the swines' isolated behavior, unaffected by staff interaction. The chronic heart failure swine (n = 3) had an average passive activity area under the curve prepandemic value of 47.23 ± 2.52 compared with pandemic 57.09 ± 2.90, pandemic 57.09 ± 2.90 compared with reentry 50.44 ± 1.61, and prepandemic compared with reentry. The atrial fibrillation swine (n = 3) had an average passive activity area under the curve minimal interaction (mimicking pandemic) value of 59.27 ± 6.67 compared with interaction (mimicking prepandemic or reentry) 37.63 ± 1.74. The heightened activity levels during minimal interaction suggest physiologic and psychologic changes in the animals due to reduced socialization. This highlights the importance of enrichment and interaction in research animals and underscores the broader impact of the COVID-19 pandemic on research outcomes. These findings could also shed light on the effects of the pandemic on human behavior.

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.

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.

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.

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.

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.

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.

An Integrative Review of Scientific Evidence for Reconnective Healing.

BACKGROUND: Biofield therapies offer a novel, non-invasive approach to treating chronic diseases based on assessing and adjusting an individual's physiological and emotional responses through their bio-energetic field. Reconnective Healing™ (RH) is defined as: "…not just energy healing, but instead a more comprehensive spectrum of healing composed of energy, light, and information." OBJECTIVES: Several biofield therapies, such as Reiki, Therapeutic Touch and Johrei, have already been reviewed in the literature but RH has received little attention even though it is taught and practiced worldwide. This review provides a critical assessment of RH as a healing modality. METHODS: Scientific research articles published in peer-reviewed journals addressing RH were identified using relevant databases and archives. Information was extracted from each article that met selection criteria for evaluation of quality of reporting and design. This review summarizes and critically evaluates the five currently published peer-reviewed research papers involving RH and assesses whether RH provides consistent physiological outcomes between the studies. RESULTS: These results, taken together, suggest: (i) exposure of a healer or healee to RH, either directly or indirectly, amplifies their degree of autonomic arousal and energy, (ii) RH can reduce pain and improve range of motion in people with shoulder limitations, and (iii) when individuals experience RH as a group, their autonomic nervous systems simultaneously show sudden similar responses consistent with the idea that RH is mitigated by entrainment of biofields. CONCLUSIONS: Since these studies are extremely varied in design it is not possible at this point to reach conclusions about the general effectiveness of RH. More clinical and physiological research performed on different populations under a range of conditions is needed in order to support this healthcare approach.

The Touchstone Process: an ongoing critical evaluation of reiki in the scientific literature.

BACKGROUND: Reiki is used by a growing number of people but little is known about the scientific basis for its use. PURPOSE: The Touchstone Process was developed as an ongoing process to systematically analyze published, peer-reviewed studies of Reiki, the results being made accessible to the public online. METHOD: Thirteen scientifically qualified experts in the field of Reiki were assembled into 3 teams to retrieve, evaluate, and summarize articles using standardized, piloted evaluation forms. RESULTS: Summaries of 26 Reiki articles, including strengths and weaknesses, were posted on a newly developed Web site (www.centerforreikiresearch.org), together with an overall summary of the status of Reiki research and guidelines for future research: The Touchstone Process determined that only 12 articles were based on a robust experimental design and utilized well-established outcome parameters. Of these articles, 2 provided no support, 5 provided some support, and 5 demonstrated strong evidence for the use of Reiki as a healing modality. CONCLUSION: There is a need for further high-quality studies in this area.

Knockout mice: is it just genetics? Effect of enriched housing on fibulin-4(+/-) mice.

BACKGROUND: Fibulin-4 is an extracellular matrix protein expressed by vascular smooth muscle cells that is essential for maintaining arterial integrity. Fibulin-4(-/-) mice die just before birth due to arterial hemorrhage, but fibulin-4(+/-) mice appear to be outwardly normal. Experiments were therefore performed to determine whether fibulin-4(+/-) mice display arterial pathologies on a microscopic scale. After preliminary experiments were performed, a second purpose developed, which was to test the hypothesis that any observed pathologies would be ameliorated by housing the animals in enriched cages. METHODOLOGY: Fibulin-4(+/-) and wild-type mice were housed either four/cage in standard cages or two per cage in larger cages, each cage containing a tunnel and a wheel. After three weeks the mice were sacrificed, and the aortas perfusion-fixed and excised for light and electron microscopy. PRINCIPLE FINDINGS: When the mice were in standard cages, localized regions of disorganized extracellular matrix and collagen fibers consistently appeared between some of the medial smooth muscle cells in the fibulin-4(+/-) mice. In the wild-type mice, the smooth muscle cells were closely connected to each other and the media was more compact. The number of disorganized regions per square mm was significantly greater for fibulin-4(+/-) mice (172+/-43 (SEM)) than for wild-type mice (15+/-8) (p<0.01, n = 8). When the mice were in enriched cages, the fibulin-4(+/-) mice showed significantly fewer disorganized regions than those in standard cages (35+/-12) (p<0.05, n = 8). The wild type mice also showed fewer disorganized regions (3+/-2), but this difference was not significant. CONCLUSIONS: These results indicate that arterial pathologies manifested in fibulin-4(+/-) mice can be reduced by enriching the housing conditions, and imply that appropriate environments may counteract the effects of some genetic deficiencies.

Transient diffusion of albumin in aortic walls: effects of binding to medial elastin layers.

The goal of this study was to measure diffusive transport of albumin through artery walls experimentally and to analyze the results theoretically, taking into account the binding of albumin to elastic lamellae. Segments of rabbit aorta were placed in solutions of fluorescently labeled albumin for periods of 30, 60, 90, and 120 min, and the distributions of fluorescence intensity through the arterial media were observed. On average, intensity increased almost linearly with time. Bands of high intensity were observed corresponding to elastin layers within the media. The temporal and spatial variations of intensity were compared with predictions of theoretical models, including effects of albumin binding and hindered diffusion resulting from the complex wall structure. Based on these analyses, it was concluded that the spatial distribution of free albumin within the media equilibrated relatively rapidly, and that the observed linear increase in intensity reflected gradual accumulation of albumin bound to medial elastin layers. The results imply that previous theoretical analyses, in which binding was neglected, substantially underestimated albumin diffusivity in the aortic wall. With respect to stent-associated delivery of inhibitors of vascular cell proliferation, the results suggest that albumin might serve as an "affinity vehicle" for drug delivery to the aorta, by attaching the drug to an abundant component of the artery wall.

Are investigators aware of environmental noise in animal facilities and that this noise may affect experimental data?

Control of environmental factors, such as noise, in animal facilities is important to ensure that research animals respond consistently to experimental procedures and that experimental results are not confounded by outside influences. A survey of personnel involved with animal facilities (173 respondents) showed that almost all agreed with this statement. However, 48% thought that one or more environmental factors in their facilities could be stressing the animals, and a majority of respondents reported generation of audible noise from people (72% of respondents), fans (61%), and squeaky carts (56%). The presence of these noises was correlated with the perception of noise as a problem because of its psychologic and physiologic effects on the animals. The amount of time respondents spent in the facilities was strongly correlated with their perception of noise as a problem, with veterinarians spending the most time and perceiving the most problems, and professors and assistant/ associate professors spending the least and perceiving the fewest. Therefore, they may lack key knowledge that can affect their research goals. In addition, because faculty are the least aware of noise as a potential problem but are primarily responsible for designing experiments, research involving animals may be confounded by noise as an unknown variable. This effect may lead to unnecessary numbers of animals being required to achieve statistical significance and possibly to erroneous interpretation of results. On the basis of the findings of this survey, we present recommendations for improving the environment, particularly for decreasing the noise level, in animal facilities.

Effect of noise on microvascular integrity in laboratory rats.

Housing rats in an environment with high personnel activity increases microvascular leakiness to albumin in the mesenteric microcirculation and causes mast cell degranulation. In this study, rats were exposed to daily 15-min episodes of 90-dB SPL noise to determine whether similar effects occurred and whether vitamin E with a-lipoic acid or Traumeel (a homeopathic anti-inflammatory-analgesic) reduced these effects. Groups of rats fed a control diet (1000 IU/kg vitamin E) only, the control diet with Traumeel, or a diet with 10,000 IU/kg vitamin E and 1.65 g/kg lipoic acid were exposed to daily noise for 3 to 5 wk; a fourth group of rats, fed control diet, was housed with no excess noise. The rats were anesthetized, the superior mesenteric artery cannulated, and a portion of the microvasculature perfused for 1 min with fluoroscein isothiocyanate-albumin before fixing for microscopy. All groups exposed to excess noise had significantly more leaks per venule length and greater leak area per venule length than did the quiet group. However, the number and area of leaks in the rats that received Traumeel or vitamin E were significantly smaller than those in rats exposed to noise only. In addition, mast cell degranulation was significantly lower in rats given Traumeel. Thus exposure of rats to excessive noise produces structural damage in the mesenteric microvasculature that is significantly reduced by dietary supplements.

Do audible and ultrasonic sounds of intensities common in animal facilities affect the autonomic nervous system of rodents?

In animal facilities, noises, often poorly controlled, occur over a wide range of frequencies and intensities. Evidence demonstrates that audible noise and ultrasound have deleterious effects on rodent physiology, but it is not known how they affect the autonomic nervous system (ANS). This study exposed 3 unrestrained, male, Sprague-Dawley rats daily to a 15-min white noise regime (90 dB), a quiet regime, or a 15-min ultrasound regime (90 dB at 4 frequencies in the range 20 to 40 kHz)--each for several weeks--and used radiotelemetry to monitor their cardiovascular responses. Exposure to audible noise increased heart rate and mean arterial pressure. Spectral analysis of HR variability showed diminished stimulation of the parasympathetic nervous system, shifting the sympathovagal balance. However, ultrasound, at the frequencies used, did not reproducibly affect cardiovascular parameters. The preliminary data obtained from this study indicate that audible noise, but not ultrasound (delivered using the same protocol), affects the ANS. Because the cardiovascular, respiratory, renal, and gastrointestinal systems are under autonomic control, such noise could have wide-ranging effects on animal physiology.

Effects of S-nitrosation on hemoglobin-induced microvascular damage.

Blood substitutes, such as diaspirin cross-linked hemoglobin (Hb), cause microvascular leakiness to macromolecules. Because of the potentially stabilizing effects of nitric acid (NO) on endothelium, experiments were performed to determine whether S-nitrosohemoglobin (SNO-Hb), a potential NO-donor Hb-based blood substitute, would not cause microvascular damage. Release of NO, or its metabolites, from the SNO-Hb was facilitated by addition of glutathione, which aids in the decomposition of S-nitrosothiols. In anesthetized rats, the mesenteric microvasculature was perfused with SNO-Hb with glutathione (six rats), SNO-Hb alone (six rats), or saline (eight rats) for 10 min, followed by fluorescein isothiocyanate (FITC)-albumin for 1 min, and finally fixed for epifluorescence microscopic examination. When comparing the SNO-Hb group with saline, both the numbers and areas of leaks were significantly increased [0.019 +/- 0.003 (SEM) microm vs. 0.0030 +/- 0.0004 and 7.36 +/- 1.50 vs. 0.156 +/- 0.035 (p < 0.005)]. With the addition of glutathione, leakage was still high (0.005 +/- 0.00005 microm and 5.086 +/- 0.064 microm) but decreased compared with SNO-Hb alone (p < 0.005). In conclusion, NO, or a related vasodilator, when released from SNO-Hb, significantly reduces but does not eliminate microvascular damage. Further improvements may result by S-nitrosating a more stable form of modified hemoglobin.

Effect of noise on the morphology of the intestinal mucosa in laboratory rats.

To determine whether noise-induced stress disrupts the intestinal mucosa of laboratory rats, one group of 8 rats ("noise" rats) was subjected to 15 min of white noise (90 dB) daily for 3 wk. Another group ("quiet"rats) was housed for 3 wk in an acoustically similar room but with no additional noise. A 3rd group ("recovery" rats) was housed in the noise room for 3 wk and then in the quiet room for a further 3 wk. The ilea were fixed for microscopy. Villi adjacent to Peyer patches showed significantly more degranulated mast cells (mean+/-standard error of the mean, 3.95+/-0.80 versus 0.35+/-0.29, respectively) and eosinophils (mean+/-standard error of the mean, 9.46+/-0.44 versus 4.58+/-0.38) per villus section in noise rats than in quiet rats. Similar results were obtained with rooms reversed, to account for any differences in room characteristics. The mean width of villus laminar propria was significantly greater in noise rats than quiet rats, suggesting edema. In addition, mucosal epithelial cells of noise rats were often separated, sometimes detaching from the basement membrane, whereas those of quiet rats were intact. Behaviorally, noise rats exhibited significantly more grooming and rearing than quiet rats. Compared with noise rats, recovery rats showed no reduction in mast cell degranulation or mean width of villus lamina propria, but there were increased numbers of secreting goblet cells in villi adjacent to Peyer patches and some recovery of epithelial integrity.

Personal interaction with a Reiki practitioner decreases noise-induced microvascular damage in an animal model.

OBJECTIVE: To determine whether Reiki, a process of transmission of healing energy, can significantly reduce microvascular leakage caused by exposure to excessive noise using an animal model. RATIONALE: Reiki is beginning to be used in hospitals to accelerate recovery. Despite many anecdotes describing Reiki's success, few scientific studies are reported and none of those use animals. Animal models have the advantage over human subjects in that they provide well-controlled, easily interpretable experiments. The use of noise is relevant to hospital patients because of the excessive ambient noise in hospitals in the United Kingdom and United States. Loud noise can lead to several nonauditory disorders in humans and animals that impair recovery. In the rat, stress from noise damages the mesenteric microvasculature, leading to leakage of plasma into the surrounding tissue. DESIGN: One group of four rats simultaneously received daily noise and Reiki, while two other groups received "sham" Reiki or noise alone. A fourth group did not receive noise or additional treatment. The experiment was performed three times to test for reproducibility. OUTCOME MEASURES: Average number and area of microvascular leaks to fluorescent albumin per unit length of venule. RESULTS: In all three experiments, Reiki significantly reduced the outcome measures compared to the other noise groups (sham Reiki and noise alone) (p < 0.01). CONCLUSIONS: Application of Reiki significantly reduces noise-induced microvascular leakage in an animal model. Whether or not these effects are caused by Reiki itself, or the relaxing effect of the Reiki practitioner, this procedure could be useful for minimizing effects of environmental stress on research animals and hospital patients.

Mast cell activation by stress.

Mental or emotional stress has been shown to cause mast cell degranulation in several different tissues. Several lines of experimental evidence indicate that stress, working through the sympathetic nervous system, or the hypothalamus-pituitary-adrenal axis, stimulates peripheral nerves to release neuropeptides that bind to receptors on the mast cells, causing them to degranulate. In order to investigate the effects of stress on mast cell degranulation, it is necessary to first establish a reproducible animal model of stress (in this case, rat) and also to ensure that the control animals do not show any signs of stress. This procedure requires a great deal of care and attention because the methods used by many institutions to house laboratory rodents, do in fact cause them stress. This topic is addressed in this chapter. In addition, two histological techniques are described to visualize connective tissue and mucosal mast cells and to assess their degree of degranulation.