Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study).

BACKGROUND: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-2015, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. METHODS: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. RESULTS: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. CONCLUSIONS: A future RCT of the coMforT TS-MBCT intervention should have an internal pilot, recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. TRIAL REGISTRATION: ISRCTN64458065 11/01/2019.

A virtual, group-based mindfulness intervention for midlife and older women with low libido lowers sexual distress in a randomized controlled pilot study.

BACKGROUND: Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM: We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS: Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES: We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS: Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS: Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS: This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION: A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.

Effect and cerebral mechanism of moxibustion at heat-sensitized Yaoyangguan (GV3) in patients with lumbar disc herniation and myofascial pain syndrome by resting-state functionality magnetic resonance imaging: protocol for an observational study.

We want to explore the analgesic brain effect of the moxibustion at heat-sensitized Yaoyangguan (GV3) in patients with lumbar disc herniation (LDH) and myofascial pain syndrome (MPS). In an assessor-blinded observational study, we will include 15 LDH and 15 MPS. They will accept same treatment of heat-sensitive moxibustion at Yaoyangguan (GV3). The resting-state functionality magnetic resonance imaging image data of brain activities before and after treatment will be analyzed by mean fractional amplitude of low-frequency fluctuation, regional homogeneity analysis and brain functional connection. We select seed of first sensory cortex, second sensory cortex, insula cortex, periaqueductal gray and anterior cingulate cortex as the regions of interest to analyse the relationship between brain functional connectivity of pain-related networks and clinical data. Our study could disclose key brain targets and central response characteristics of the analgesic brain effect and the brain functional connection of heat-sensitive moxibustion.

Feasibility and acceptability of e-learning to upskill diabetes educators in supporting people experiencing diabetes distress: a pilot randomised controlled trial.

BACKGROUND: Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. METHODS: A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. RESULTS: Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up.  CONCLUSIONS: The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

Mixed methods research in complementary and alternative medicine: a scoping review.

OBJECTIVE: To update the current characteristics about the scope and quality of mixed methods research (MMR) in complementary and alternative medicine (CAM) after nearly 10 years. METHODS: A 5-stage approach for conducting a scoping review was adopted. Articles published on the top 10 journals in CAM with the highest impact factor in 2020 were screened for MMR. Information of included articles were extracted, and then synthesized to illustrate the current state. Methodological quality was evaluated according to the Mixed Method Appraisal Tool (MMAT) 2018 version. RESULTS: A total of 55 (55/2991, 2%) articles using mixed methods were retrieved, including 17 medical studies and 38 ethnobotanical studies. We performed an in-depth analysis on the 17 medical studies, which studied cancer, stress, pain, fatigue, exercises, mindfulness intervention, herbal medicine use, art and acupuncture. Thirteen pilot studies applied MMR to evaluate the feasibility of interventions or programs (13/17, 76%); phenomenology was inferred as the most common philosophical assumptions (13/17, 76%); the most applied type of MMR was convergent design (16/17, 94%); integration often took place at integration (12/17, 71%). Among the 16 eligible studies for quality appraisal, majority were rated as good (14/16, 88%), whereas two studies were rated as poorly described. Primarily, a poor rating was due to incomplete reporting of data analysis and citations in qualitative components; lack of confounder controlling and the sampling strategy in quantitative components; poor description of integration and justification for mixed methods. Comparing with the previous review, fewer MMR were published in 2020 in CAM, but the proportion of studies that clearly reported MMR has increased by 4 times (4%→15%). CONCLUSION: CAM researchers need to realize the benefits that MMR can have on conducting further health care research. Our findings highlight that applying MMR will be helpful to understand the complex dynamics and interdisciplinary nature of complex intervention. In addition, addressing a standardized reporting criteria for MMR is recommended.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain.

BACKGROUND: Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. METHODS: This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. RESULTS: We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. CONCLUSIONS: We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Exploring the Feasibility of a Mindfulness-Music Therapy Intervention to Improve Anxiety and Stress in Adolescents and Young Adults with Cancer.

CONTEXT: Adolescent and young adults (AYAs) with cancer experience significant psychological distress due to cancer treatment that can persist long after treatment. However, little is known regarding optimal interventions to support the psychosocial needs of AYAs with cancer. OBJECTIVE: The overall objective of this single arm, longitudinal, pilot study was to determine the feasibility of implementing a mindfulness-based music therapy intervention to improve anxiety and stress in AYAs receiving cancer treatment. METHODS: AYAs (15 - 39 years old) who were to receive cancer treatment for ≥ eight weeks were recruited from the pediatric, melanoma, sarcoma, breast, lymphoma, and leukemia oncology outpatient centers at Dana-Farber Cancer Institute. The music therapy intervention included four sessions of individual mindfulness-based music therapy in-person or using Zoom over twelve weeks. Prior to-and after the intervention period, participants completed the Patient-Reported Outcomes Measurement Information Anxiety 4a and Perceived Stress Scale. Changes in patient-reported outcomes are compared using Wilcoxon signed-rank tests. RESULTS: Over ∼14 months, 37 of 93 eligible AYAs were enrolled to the study (39.8% consent rate). Overall, 27 of 37 (73%) participants (Median age=32; 56.8% Female) completed at least two music therapy sessions and the baseline measures and end of study measures. Participation in the mindfulness-based music therapy sessions resulted in significant pre-to-posttest improvements in perceived stress (median change: -4.0, P = 0.013) and non-significant changes in anxiety (median change: -1.9, P = 0.20). Satisfaction and acceptability were highly rated. CONCLUSIONS: The delivery of a four-session mindfulness-based music therapy intervention to AYAs receiving chemotherapy was feasible and significantly improved perceived stress. These preliminary findings should be confirmed in a randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03709225.

Effect of acupressure on postpartum low back pain, salivary cortisol, physical limitations, and depression: a randomized controlled pilot study.

OBJECTIVE: To investigate the effect of acupressure on postpartum low back pain (LBP), salivary cortisol, physical limitations, and postpartum depression. METHODS: Participants were 70 postpartum women who were randomly assigned to either an intervention (n = 35) or a control (n = 35) group. The intervention group received 10 acupressure sessions (1 session per day, 5 d per week). The control group received 10 sham acupressure sessions. Outcomes were assessed using a visual analogue scale (LBP intensity), salivary cortisol values (LBP biomarker), and Chinese versions of the Roland-Morris Disability Questionnaire (daily activity limitations), Oswestry Disability Index (physical activity limitations), and the Edinburgh Postnatal Depression Scale (postpartum depression). RESULTS: Participants in the intervention group had significantly lower levels of LBP intensity, daily activity limitations, physical activity limitations, and postpartum depression than those in the control group. There was no significant between-group difference in salivary cortisol. CONCLUSION: Acupressure may reduce postpartum LBP intensity and limitations in daily and physical activity, and alleviate postpartum depressive symptoms. Acupressure should be offered in postpartum care settings as an alternative treatment for postpartum women with LBP.

A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting.

BACKGROUND: The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in a Danish municipal health care center setting. METHODS: A three-armed parallel pilot RCT was conducted among 71 adults who contacted a Danish municipal health care center due to stress-related problems. Recruitment was made between January and April 2018 and followed usual procedures. EXCLUSION CRITERIA: 1) acute treatment-demanding clinical depression or diagnosis of psychosis or schizophrenia, 2) abuse of alcohol, drugs, medicine, 3) pregnancy. Randomisation was performed by an independent data manager using the REDCap electronic data capture tool. The primary outcome was a description of RCT feasibility (recruitment and retention rates regarding intervention participation and 12-week follow-up). Secondary outcomes were completion rates regarding questionnaire data and proposed effect-estimates of outcome measures considered to be used in the following real RCT. Type of intervention and outcome assessment were not blinded. RESULTS: We recruited 71 of 129 eligible individuals from the target population (55, 95%CI: 46-64). Forty-two (59%) were females. Median age: 44 years (1-quartile:34, 3-quartile:50). Twenty-nine (41%) had < 16 years of education. Forty-eight (68%) were employed; 30 of these 48 (63%) were on sick leave. Mean scores for perceived stress (PSS): 25.4 ± 5.3; symptoms of anxiety and depression (SCL-5): 2.9 ± 0.6, and well-being (WHO-5): 31.7 ± 8.5 indicated a need for intervention. 16/24 (67, 95%CI: 45 to 84) who were allocated to MBSR and 17/23 (74, 95%CI: 52 to 90) who were allocated to LSR participated in ≥5 sessions. The loss to follow-up at 12 weeks: MBSR: 5 (21% (95% CI: 7 to 42), LSR: 5 (22% (95% CI: 7 to 44) and waiting list: 4 (17% (95% CI: 5 to 37). This was acceptable and evenly distributed. The results indicated MBSR to be superior. CONCLUSIONS: An RCT assessing the effectiveness of stress reduction interventions in a real-life municipal health care setting is feasible among adults with a clear need for stress reduction interventions based on scores on mental health. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.

Understanding How Virtual Reality Can Support Mindfulness Practice: Mixed Methods Study.

BACKGROUND: Regular mindfulness practice has been demonstrated to be beneficial for mental health, but mindfulness can be challenging to adopt, with environmental and personal distractors often cited as challenges. Virtual reality (VR) may address these challenges by providing an immersive environment for practicing mindfulness and by supporting the user to orient attention to the present moment within a tailored virtual setting. However, there is currently a limited understanding of the ways in which VR can support or hinder mindfulness practice. Such an understanding is required to design effective VR apps while ensuring that VR-supported mindfulness is acceptable to end users. OBJECTIVE: This study aimed to explore how VR can support mindfulness practice and to understand user experience issues that may affect the acceptability and efficacy of VR mindfulness for users in the general population. METHODS: A sample of 37 participants from the general population trialed a VR mindfulness app in a controlled laboratory setting. The VR app presented users with an omnidirectional video of a peaceful forest environment with a guided mindfulness voiceover that was delivered by a male narrator. Scores on the State Mindfulness Scale, Simulator Sickness Questionnaire, and single-item measures of positive and negative emotion and arousal were measured pre- and post-VR for all participants. Qualitative feedback was collected through interviews with a subset of 19 participants. The interviews sought to understand the user experience of mindfulness practice in VR. RESULTS: State mindfulness (P<.001; Cohen d=1.80) and positive affect (P=.006; r=.45) significantly increased after using the VR mindfulness app. No notable changes in negative emotion, subjective arousal, or symptoms of simulator sickness were observed across the sample. Participants described the user experience as relaxing, calming, and peaceful. Participants suggested that the use of VR helped them to focus on the present moment by using visual and auditory elements of VR as attentional anchors. The sense of presence in the virtual environment (VE) was identified by participants as being helpful to practicing mindfulness. Interruptions to presence acted as distractors. Some uncomfortable experiences were discussed, primarily in relation to video fidelity and the weight of the VR headset, although these were infrequent and minor. CONCLUSIONS: This study suggests that an appropriately designed VR app can support mindfulness practice by enhancing state mindfulness and inducing positive affect. VR may help address the challenges of practicing mindfulness by creating a sense of presence in a tailored VE; by allowing users to attend to visual and auditory anchors of their choice; and by reducing the scope of the content in users' mind-wandering. VR has the unique capability to combine guided mindfulness practice with tailored VEs that lend themselves to support individuals to focus attention on the present moment.

A Coaching Program to Improve Dietary Intake of Patients with CKD: ENTICE-CKD.

BACKGROUND AND OBJECTIVES: The dietary self-management of CKD is challenging. Telehealth interventions may provide an effective delivery method to facilitate sustained dietary change. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This pilot, randomized, controlled trial evaluated secondary and exploratory outcomes after a dietitian-led telehealth coaching intervention to improve diet quality in people with stage 3-4 CKD. The intervention group received phone calls every 2 weeks for 3 months (with concurrent, tailored text messages for 3 months), followed by 3 months of tailored text messages without telephone coaching, to encourage a diet consistent with CKD guidelines. The control group received usual care for 3 months, followed by nontailored, educational text messages for 3 months. RESULTS: Eighty participants (64% male), aged 62±12 years, were randomized to the intervention or control group. Telehealth coaching was safe, with no adverse events or changes to serum biochemistry at any time point. At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5). There was no change in clinic BP at any time point in any group. There were significant improvements in several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight. CONCLUSIONS: Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in several exploratory diet and clinical outcomes, which require further investigation. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Evaluation of Individualized Telehealth Intensive Coaching to Promote Healthy Eating and Lifestyle in CKD (ENTICE-CKD), ACTRN12616001212448.

Guideline implementation in the Canadian chiropractic setting: a pilot cluster randomized controlled trial and parallel study.

Background: Feasibility and pilot studies are recommended prior to embarking on large-scale costly confirmatory trials. The objectives were to determine the feasibility of conducting a cluster randomized controlled trial (C-RCT) to evaluate a complex knowledge translation (KT) intervention to improve the management of people with neck pain, and to identify challenges and potential solutions to conducting a fully powered C-RCT in the chiropractic setting. Methods: Pilot C-RCT involving a nationally representative sample of chiropractors and patients. We invited 400 chiropractors and 150 patients to participate. Clinicians were randomized to receive either an online theory-based KT educational and brief action plan (BAP) intervention (intervention group) or a copy of a clinical practice guideline (control group). Study-related challenges were ascertained via mid-study phone interviews and end-of-study feedback questionnaires. Analyses focused on descriptive estimates of likely recruitment, retention, and adherence rates, and documentation of potential barriers. Results: In total, 47 chiropractors (12%) agreed to participate and were randomized after resampling. Fifteen withdrew from the study, leaving a total of 32 (8%) participants. Eleven chiropractors in the intervention group completed the webinars and e-learning modules, two partially completed them and three did not register. Participating chiropractors recruited a total of 29 patients. Sixty-three percent (n = 7) of intervention and 56% (n = 10) of control group patients completed all outcome measures at both baseline and 3-months follow-up, attended follow-up visits and performed home exercises. Patients in the intervention group reported significant reductions in pain (mean 1.6, 95% CI 0.26-2.94, P = 0.027) and disability scores (9.8, 95% CI 3.68-15.91, P = 0.033) from baseline to 3-month follow-up. Key barriers to participation reported by chiropractors included lack of time, difficulties in recruiting patients, problems with the administration of study questionnaires, concern that the clinician-patient relationship might be jeopardized, and lack of assistance from office staff. Over half (55%) of the respondents in the intervention group encountered some difficulty registering or completing the educational modules. Conclusion: Recruitment of clinicians and patients for a trial of a complex intervention can be challenging, and retention of participants after enrolment may be low. Future trials of this nature likely require multiple recruitment strategies to achieve desired sample sizes. Moreover, time-constraint issues are perceived particularly by clinicians as a major barrier to both study enrolment before, and protocol adherence during, their actual participation in a trial. Trial registration: The study was registered at, NCT02483091, on 17th June 2015.

Improving Dental Students Fine Motor Skills by Visualization and Mental Imagery: A Pilot Randomized Clinical Trial / Mejora de las Habilidades Motoras Finas de los Estudiantes de Odontología Mediante Visualización e Imaginería: Ensayo Clínico Aleatorizado Piloto

ABSTRACT: Clinical motor skills are essential to train dental students. There is evidence that imagery serves to acquire and improve motor skills, since imagining an action, activates the same neural areas as when this is physically performed. The aim of this pilot randomized clinical trial was to examine the feasibility of tridimensional visualization associated with mental imagery on the development of fine motor skills of dental students compared to conventional training. Seventeen dental students without previous preclinical experiences, between 18-25 years old were recruited. After giving a theoretical lecture on the inlay preparation, participants were randomly allocated in two groups. The Experimental Group (N=9) performed daily 30 minutes of "mental practice" after visualizing a video showing the execution of an ideal inlay preparation alternating it with black screen periods to facilitate the imagery. The Control Group (N= 8) performed a 30 minutes "hands on practice" daily of the same preparation. On the fifth day, both groups carried out an inlay preparation physically, which was scanned and overlapped to the virtual preparation to assess accuracy. The execution time and accuracy of the preparation performed with regard to an ideal preparation were compared between groups. The learning style and fine motor skills at baseline were similar in all participants (P>0.001). No statistically significant differences were found between the groups in terms of accuracy. The time of execution in the experimental group was significantly lower than the control group. This pilot study showed that visualization associated to mental imagery could develop fine motor skills in dental students, requiring less execution time than physical practice.

RESUMEN: Las habilidades motoras clínicas son esenciales para entrenar a los estudiantes de odontología. Existe evidencia que la imaginería sirve para adquirir y mejorar las habilidades motoras, ya que al imaginar una acción, se activan las mismas áreas neuronales que cuando la acción se realiza físicamente. El objetivo de este ensayo clínico aleatorizado piloto fue examinar la factibilidad del uso de visualización tridimensional asociada con imaginería para el desarrollo de las habilidades motoras finas en estudiantes de odontología comparado con el entrenamiento convencional. Se reclutaron diecisiete estudiantes de odontología, entre 18-25 años de edad, sin experiencias preclínicas previas. Después de recibir una clase teórica sobre la preparación de una incrustación, los participantes fueron asignados aleatoriamente a dos grupos. El grupo experimental (N = 9) realizó diariamente 30 minutos de "práctica mental" después de visualizar un video que muestra la ejecución de una preparación de incrustación ideal alternando con períodos de pantalla negra para facilitar la imaginación. El grupo de control (N = 8) realizó una práctica diaria de 30 minutos de la misma preparación. El quinto día, ambos grupos llevaron a cabo físicamente una preparación de incrustación, que fue escaneada y esta imagen se superpuso a la preparación virtual ideal para evaluar la precisión. El tiempo de ejecución y la precisión de la preparación realizada con respecto a una preparación ideal se compararon entre ambos grupos. El estilo de aprendizaje y las habilidades motoras finas al inicio del estudio fueron similares en todos los participantes (P > 0,001). No se encontraron diferencias estadísticamente significativas entre los grupos en términos de precisión. El tiempo de ejecución en el grupo experimental fue significativamente menor que en el grupo control. Este estudio piloto mostró que la visualización asociada a imaginería podría desarrollar habilidades motoras finas en estudiantes de odontología, requiriendo menos tiempo de ejecución que la práctica física.

Acupuncture in living liver and kidney donors: a feasibility study.

OBJECTIVE: The purpose of this study was to test the feasibility of integrating acupuncture into the routine care of living liver and kidney donors during the process of donation and recovery. METHODS: This is a pilot study on the feasibility of a brief acupuncture intervention for living liver and kidney donors. Participants received acupuncture immediately prior to organ donation surgery, every day as inpatients, while recovering from donation, and at a 2-week follow-up. Prior to surgery, questionnaires were completed on acupuncture outcome expectations and the State-Trait Anxiety Inventory. After participating, those who received acupuncture provided feedback. Following the active intervention, a retrospective chart review was conducted, using donors who did not receive acupuncture as a comparison cohort. RESULTS: Forty donor candidates were approached and recruited, 32 consented and ultimately 25 donors participated in the acupuncture intervention (15 of kidney, 10 of liver), 68% female, and 88% Caucasian; only one had prior experience with acupuncture. Participants received an average of 4 sessions while inpatient (range 2-8). Those who expected acupuncture to be more helpful prior to the intervention reported lower inpatient pain scores (P = 0.04). Qualitative feedback from patients was predominantly positive, indicating acupuncture was helpful for relaxation and pain. However, a few patients reported feeling overburdened during postdonation recovery, and that the study was viewed as additional obligation. CONCLUSION: Preliminary findings suggest it is feasible to integrate acupuncture into inpatient recovery for living organ donation. Tailoring interventions to the specific needs of patients is important to address ongoing concerns. Larger studies are needed to further ascertain benefits of peri-operative acupuncture.

Acupuncture in living liver and kidney donors: a feasibility study / 中西医结合学报

OBJECTIVE@#The purpose of this study was to test the feasibility of integrating acupuncture into the routine care of living liver and kidney donors during the process of donation and recovery.@*METHODS@#This is a pilot study on the feasibility of a brief acupuncture intervention for living liver and kidney donors. Participants received acupuncture immediately prior to organ donation surgery, every day as inpatients, while recovering from donation, and at a 2-week follow-up. Prior to surgery, questionnaires were completed on acupuncture outcome expectations and the State-Trait Anxiety Inventory. After participating, those who received acupuncture provided feedback. Following the active intervention, a retrospective chart review was conducted, using donors who did not receive acupuncture as a comparison cohort.@*RESULTS@#Forty donor candidates were approached and recruited, 32 consented and ultimately 25 donors participated in the acupuncture intervention (15 of kidney, 10 of liver), 68% female, and 88% Caucasian; only one had prior experience with acupuncture. Participants received an average of 4 sessions while inpatient (range 2-8). Those who expected acupuncture to be more helpful prior to the intervention reported lower inpatient pain scores (P = 0.04). Qualitative feedback from patients was predominantly positive, indicating acupuncture was helpful for relaxation and pain. However, a few patients reported feeling overburdened during postdonation recovery, and that the study was viewed as additional obligation.@*CONCLUSION@#Preliminary findings suggest it is feasible to integrate acupuncture into inpatient recovery for living organ donation. Tailoring interventions to the specific needs of patients is important to address ongoing concerns. Larger studies are needed to further ascertain benefits of peri-operative acupuncture.

Rhythm-centred music making in community living elderly: a randomized pilot study.

BACKGROUND: Quality of life has become an important aspect in the measurement of the health of an individual as the population ages. Rhythm-centred music making (RMM) has been shown to improve physical, psychological and social health. The purpose of this study was to explore the effects of RMM on quality of life, depressive mood, sleep quality and social isolation in the elderly. METHODS: A randomised controlled trial with cross over was conducted. 54 participants were recruited with 27 participants in each arm. In phase 1, group A underwent the intervention with group B as the control. In phase 2, group B underwent the intervention with group A as the control. The intervention involved 10 weekly RMM sessions. Patient related outcome data which included European Quality of Life-5 Dimensions (EQ5D), Geriatric Depression Scale (GDS), Pittsburg Sleep Quality Index (PSQI) and Lubben Social Network Scale (LSNS) scores were collected before the intervention, at 11th and at the 22nd week. RESULTS: A total of 31 participants were analyzed at the end of the study. The mean age was 74.65 ± 6.40 years. In analysing the change in patient related outcome variables as a continuous measure, participation in RMM resulted in a non-significant reduction in EQ5D by 0.004 (95% CI: -0.097,0.105), GDS score by 0.479 (95% CI:-0.329,1.287), PSQI score by 0.929 (95% CI:- 0.523,2.381) and an improvement in LSNS by 1.125 (95% CI:-2.381,0.523). In binary analysis, participation in RMM resulted in a 37% (OR = 1.370, 95% CI: 0.355,5.290), 55.3% (OR = 1.553, 95% CI: 0.438,5.501), 124.1% (OR = 2.241, 95% CI = 0.677,7.419) and 14.5% (OR = 1.145, 95% CI = 0.331,3.963) non-significant increase in odds of improvement in EQ5D, GDS, PSQI and LSNS scores respectively. CONCLUSION: Participation in RMM did not show any statistically significant difference in the quality of life of the participants. It is however, an interesting alternative tool to use in the field of integrative medicine. Moving forward, a larger study could be performed to investigate the effects of RMM on the elderly with an inclusion of a qualitative component to evaluate effects of RMM that were not captured by quantitative indicators. TRIAL REGISTRATION: This trial was retrospectively registered. This trial was registered in the Australian New Zealand Clinical Trials Registry under trial number ACTRN12616001281482 on 12 September 2016.

Acceptance and Commitment Therapy for Inpatients with Psychosis (the REACH Study): Protocol for Treatment Development and Pilot Testing.

Patients with schizophrenia-spectrum disorders frequently require treatment at inpatient hospitals during periods of acute illness for crisis management and stabilization. Acceptance and Commitment Therapy (ACT), a "third wave" cognitive-behavioral intervention that employs innovative mindfulness-based strategies, has shown initial efficacy in randomized controlled trials for improving acute and post-discharge outcomes in patients with psychosis when studied in acute-care psychiatric hospitals in the U.S. However, the intervention has not been widely adopted in its current form because of its use of an individual-only format and delivery by doctoral-level research therapists with extensive prior experience using ACT. The aim of the Researching the Effectiveness of Acceptance-based Coping during Hospitalization (REACH) Study is to adapt a promising acute-care psychosocial treatment for inpatients with psychosis, and to pilot test its effectiveness in a routine inpatient setting. More specifically, we describe our plans to: (a) further develop and refine the treatment and training protocols, (b) conduct an open trial and make further modifications based on the experience gained, and

The Efficacy of Lavender Aromatherapy in Reducing Preoperative Anxiety in Ambulatory Surgery Patients Undergoing Procedures in General Otolaryngology.

Background: Preoperative anxiety is a common problem in hospitals and other health care centers. This emotional state has been shown to negatively impact patient satisfaction and outcomes. Aromatherapy, the therapeutic use of essential oils extracted from aromatic plants, may offer a simple, low-risk and cost-effective method of managing preoperative anxiety. The purpose of this study was to evaluate the efficacy of lavender aromatherapy in reducing preoperative anxiety in ambulatory surgery patients undergoing procedures in general otolaryngology. Methods: A prospective and controlled pilot study was conducted with 100 patients who were admitted to New York-Presbyterian/Weill Cornell Medical Center for ambulatory surgery from January of 2015 to August of 2015. The subjects were allocated to two groups; the experimental group received inhalation lavender aromatherapy in the preoperative waiting area while the control group received standard nursing care. Both groups reported their anxiety with a visual analog scale (VAS) upon arriving to the preoperative waiting area and upon departure to the operating room. Results: According to a Welch's two sample t-test, the mean reduction in anxiety was statistically greater in the experimental group than the control group (p = 0.001). Conclusion: Lavender aromatherapy reduced preoperative anxiety in ambulatory surgery patients. This effect was modest and possibly statistically significant. Future research is needed to confirm the clinical efficacy of lavender aromatherapy. Level of Evidence: 2b.

Critique of a practice-based pilot study in chiropractic practices in Western Australia.

BACKGROUND: Practice-based data collection can offer insight into the nature of chiropractic practice and contribute to resolving the conundrum of the chiropractic profession's role in contemporary healthcare, subsequently informing care service policy. However, there is little formal data available about chiropractic practice to inform decision-makers about the nature and role of chiropractic within the context of a modern multidisciplinary healthcare context in Australia, particularly at a local and regional level. METHODS: This was a mixed-methods data transformation model (qualitative to quantitative) pilot study the purpose of which was to provide a critique of the research design and collect data from a selected sample of chiropractic practices in Western Australia, with a view to offer recommendations related to the design, feasibility and implementation of a future confirmatory study. RESULTS: A narrative critique of the research methods of this pilot study is offered in this paper covering: (a) practice and patient recruitment, (b) enrollment of patients, (c) data collection methods, (d) acceptability of the study methods, (e) sample size calculations, and (f) design critique. CONCLUSIONS: The result of this critique provides a sensible sample size estimate and recommendations as to the design and implementation of a future confirmatory study. Furthermore, we believe that a confirmatory study is not only feasible, but indeed necessary, with a view to offer meaningful insight into chiropractic practice in Western Australia. TRIAL REGISTRATION: ACTRN12616000434493 Australian New Zealand Clinical Trials Registry (ANZCTR). Registered 5 April 2016. First participant enrolled 01 July 2014, retrospectively registered.