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

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

Validation of the Brazilian Version of the Langer Mindfulness Scale.

Background and Purpose: The Langer Mindfulness Scale (LMS) is distinguished from other mindfulness scales by its dimensions, which are closely related to the awareness and experience of novelty, and by being a scale derived from a cognitive perspective of information processing. There are no mindfulness instruments of this type available in Brazil. Therefore, this study aimed to carry out a translation and cultural adaptation of the LMS into Brazilian Portuguese and to validate and assess the internal consistency and convergent construct validity of the translated instrument. Methods: The study had two distinct stages: (a) translation and cultural adaptation of the LMS into Brazilian Portuguese and (b) validation of the adapted instrument using a sample of 543 participants. Results: The Brazilian version of the LMS demonstrated acceptable internal consistency, with confirmatory factor analysis supporting the original four-factor model. Correlations between LMS, and the Five Facets of Mindfulness Questionnaire and the Mindfulness Attention Awareness Scale were statistically significant and in the expected directions. Conclusions: Our findings suggest that the Brazilian version of LMS, with its four dimensions, presents acceptable psychometric properties and seems to be a reliable and valid instrument for assessing the state of mindfulness in a Brazilian cultural context.

Instruments and scales for the evaluation of acute radiation dermatitis: A systematic review.

Various assessment instruments have been proposed to document and evaluate radiation dermatitis. In this systematic review, we identified nineteen instruments or scales for the evaluation of radiation dermatitis and performed a critical review of the signs and symptoms included in each of them. Of those scales, only two have been validated. There is a need to revise the currently used instruments so to improve their capability to measure all relevant aspects of radiation dermatitis and their severity. In addition, it would be important to add the patients' view of their conditions and how they affect their lives. Finally, in order to be useful in clinical and research settings, instruments for evaluation of radiation dermatitis should be submitted to the validation process that is currently prescribed in the field of outcome measures development.

Who Benefits the Most From Different Psychological Chronic Pain Treatments? An Exploratory Analysis of Treatment Moderators.

Different psychological chronic pain treatments benefit some individuals more than others. Understanding the factors that are associated with treatment response-especially when those factors differ between treatments-may inform more effective patient-treatment matching. This study aimed to identify variables that moderate treatment response to 4 psychological pain interventions in a sample of adults with low back pain or chronic pain associated with multiple sclerosis, spinal cord injury, acquired amputation, or muscular dystrophy (N = 173). The current study presents the results from secondary exploratory analyses using data from a randomized controlled clinical trial which compared the effects of 4 sessions of cognitive therapy (CT), hypnosis focused on pain reduction (HYP), hypnosis focused on changing pain-related cognitions and beliefs (HYP-CT), and a pain education control condition (ED). The analyses tested the effects of 7 potential treatment moderators. Measures of primary (pain intensity) and secondary (pain interference, depression severity) outcome domains were administered before and after the pain treatments, and potential moderators (catastrophizing, hypnotizability, and electroencephalogram (EEG)-assessed oscillation power across five bandwidths) were assessed at pre-treatment. Moderator effects were tested fitting regression analyses to pre- to post-treatment changes in the three outcome variables. The study findings, while preliminary, support the premise that pre-treatment measures of hypnotizability and EEG brain activity predict who is more (or less) likely to respond to different psychological pain treatments. If additional research replicates the findings, it may be possible to better match patients to their more individually suitable treatment, ultimately improving pain treatment outcomes. PERSPECTIVE: Pre-treatment measures of hypnotizability and EEG-assessed brain activity predicted who was more (or less) likely to respond to different psychological pain treatments. If these findings are replicated in future studies, they could inform the development of patient-treatment matching algorithms.

The Effect of a Group Physical Activity Program on Behavior of Incarcerated Youth.

Behavioral health challenges are more prevalent in incarcerated youth than in the general youth population. Questions remain regarding whether physical activity programs can reduce behavioral health challenges in incarcerated youth. Data were available for 1,285 youths incarcerated between January 2017 and December 2018. The structured exercise program was implemented in January 2018. Primary outcomes were numbers of use of force (UoF) and of program modifications (PMs) indicative of delinquent behavior in pre- and post-exercise implementation periods. Rates per 1,000 person-days for UoF (10.0 in 2017 vs. 7.4 in 2018) and for PMs (36.7 vs. 22.9) were statistically different. For youths incarcerated both years, rates per 1,000 person-days for UoF (12.3 vs. 7.9), and for PMs (43.3 vs. 23.5) were statistically different. There was a reduction in behavior modifications in incarcerated youths after implementing the exercise program, but further studies are needed to confirm these results.

Short partial doffs of release/relock sockets may effectively stabilize limb fluid volume in prosthesis users with transtibial amputation.

BACKGROUND: A challenge often faced by people with lower extremity amputation is management of prosthetic socket fit due to changes in fluid volume within their residual limb. Prior research suggests that intermittently doffing the prosthetic socket may help stabilize daily residual limb fluid volume. METHODS: To assess the effects of partial doff duration on residual limb fluid volume retention, participants with transtibial amputation were tested by walking on a treadmill in a controlled, laboratory setting under three conditions. An automated system to release the locking pin and enlarge the socket was used to produce the partial doffing. Percent limb fluid volume changes after partial doffing for 4 min (Short Rest) and for 10 min (Long Rest) were compared with no partial doffing (No Release). Limb fluid volume was monitored using bioimpedance analysis. FINDINGS: Mean percent fluid volume changes in the posterior region were  -1.2% for No Release, 2.7% for Short Rest, and 1.0% for Long Rest. Short and Long Rests had larger increases than No Release (P = 0.005 and 0.03, respectively); Short and Long Rests were not statistically different (P = 0.10). Eight of the thirteen participants experienced a higher percent fluid volume gain for both release protocols while four experienced a higher percent fluid volume gain for only one release protocol. INTERPRETATION: A partial doff duration as short as 4 min may be an effective strategy to stabilize limb fluid volume in prosthesis users with transtibial amputation. Trials in at-home settings should be pursued.

Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized-Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women.

We report the successful closure of Phase I clinical trials, comprising Phases Ia and Ib, of the vaccine candidate against human schistosomiasis: the Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE). Shown here are the results of Phase Ib, an open, non-placebo-controlled, standardized-dose immunization trial involving 10 healthy 18-49-year-old women. Fifty micrograms of the Sm14 protein plus 10 µg GLA-SE per dose was given intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant female rabbits, we did not find any toxicological features in either the offspring or mothers, and the vaccine induced adaptive immunity in the animals. In women, no adverse events were observed, and vaccination induced high titers of anti-Sm14 serum IgG antibody production. Vaccination also elicited robust cytokine responses, with increased TNFα, IFNγ, and IL-2 profiles in all vaccinees on days 90 and 120. The completion of Phase I clinical trials, which were performed to the highest standards set by Good Clinical Research Practice (GCP) standards, and preclinical data in pregnant rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.

Perceived Community Participation and Associated Factors in People With Stroke.

Objective: To examine individual- and environmental-level factors associated with perceived participation performance and satisfaction in people with chronic stroke. Design: Cross-sectional study using secondary data analysis of baseline data from a randomized controlled trial. Setting: Community-based setting. Participants: Community-dwelling adults with mild to moderate stroke (N=113; mean age=57 years; 58 males). Interventions: Not applicable. Main Outcome Measures: Main outcomes were measured with the Reintegration to Normal Living Index (perceived participation performance) and Patient-Reported Outcome Measure Information System satisfaction with participation in social roles (perceived participation satisfaction). Other variables collected included personal (eg, age, perceived recovery), health-related (eg, time since stroke, number of comorbidities), body function-related (eg, Stroke Impact Scale, Center for Epidemiologic Studies Depression Scale), and environmental (eg, World Health Organization Quality of Life Short Form Environmental subscale) data. Results: Depression, fatigue, mobility, and environmental support showed moderate to strong, statistically significant associations with participation performance and satisfaction in people with stroke. Perceived recovery was moderately associated with participation performance but not with participation satisfaction. Conclusions: Returning to participation is a complex process after stroke. Results suggest that various personal, body function-related, and environmental factors are associated with participation performance and satisfaction.

Implementation of a Physical Activity Vital Sign in Primary Care: Associations Between Physical Activity, Demographic Characteristics, and Chronic Disease Burden.

INTRODUCTION: Physical activity is important to prevent and manage multiple chronic medical conditions. The objective of this study was to describe the implementation of a physical activity vital sign (PAVS) in a primary care setting and examine the association between physical activity with demographic characteristics and chronic disease burden. METHODS: We extracted data from the electronic medical records of patients who had visits from July 2018 through January 2020 in a primary care clinic in which PAVS was implemented as part of the intake process. Data collected included self-reported physical activity, age, sex, body mass index, race, ethnicity, and a modified Charlson Comorbidity Index score indicating chronic disease burden. We classified PAVS into 3 categories of time spent in moderate to strenuous intensity physical activity: consistently inactive (0 min/wk), inconsistently active (<150 min/wk), and consistently active (≥150 min/wk). We used χ2 tests of independence to test for association between PAVS categories and all other variables. RESULTS: During the study period, 13,704 visits, corresponding to 8,741 unique adult patients, had PAVS recorded. Overall, 18.1% of patients reported being consistently inactive, 48.3% inconsistently active, and 33.7% consistently active. All assessed demographic and clinical covariates were associated with PAVS classification (all P < .001). Larger percentages of consistent inactivity were reported for female, older, and underweight or obese patients. Larger percentages of consistent activity were reported for male, younger, and normal weight or overweight patients. CONCLUSION: Using PAVS as a screening tool in primary care enables physicians to understand the physical activity status of their patients and can be useful in identifying inactive patients who may benefit from physical activity counseling.

Performance of an auto-adjusting prosthetic socket during walking with intermittent socket release.

Introduction: A challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking. Methods: Adjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume. Results: In six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator's range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system. Conclusions: Stable operation of the control system suggests that the auto-adjusting socket is ready for testing in users' at-home settings.

Cyclic socket enlargement and reduction during walking to minimize limb fluid volume loss in transtibial prosthesis users.

The purpose of this research was to pursue an innovative cyclic panel-pull strategy during ambulation to minimize limb fluid volume loss in transtibial prosthesis users. Participants' traditional socket shapes were duplicated, and test sockets prepared with three adjustable motor-driven panels that were controlled by a microprocessor. After donning the prosthesis, participants' liners were fastened to the panels. During a 40 min test session, participants conducted three cycles of sitting (5 min) and walking (8 min). During the 5th and 6th min of each cycle of walking, the panels were cyclically pulled outward in late stance phase, decreasing pressure on the residual limb. Panels were returned to their original position in swing phase. Eight of twelve participants gained more fluid volume while walking when panel-pull was added than when it was removed. When the liner was uncoupled from the panels and panel-pull was executed, eight of twelve participants gained less fluid volume compared to when the liner was fastened to the panels. Panel-pull may facilitate limb fluid volume retention in transtibial prosthesis users. Efforts to simplify the design so that it can be implemented in long-term testing during at-home use should be considered.

Effects of hypnosis vs mindfulness meditation vs education on chronic pain intensity and secondary outcomes in veterans: a randomized clinical trial.

ABSTRACT: Effective, rigorously evaluated nonpharmacological treatments for chronic pain are needed. This study compared the effectiveness of training in hypnosis (HYP) and mindfulness meditation (MM) with an active education control (ED). Veterans (N = 328) were randomly assigned to 8 manualized, group-based, in-person sessions of HYP (n = 110), MM (n = 108), or ED (n = 110). Primary (average pain intensity [API]) and secondary outcomes were assessed at pretreatment, posttreatment, and 3 and 6 months posttreatment. Treatment effects were evaluated using linear regression, a generalized estimating equation approach, or a Fisher exact test, depending on the variable. There were no significant omnibus between-group differences in pretreatment to posttreatment change in API; however, pretreatment to posttreatment improvements in API and several secondary variables were seen for participants in all 3 conditions. Participation in MM resulted in greater decreases in API and pain interference at 6 months posttreatment relative to ED. Participation in HYP resulted in greater decreases in API, pain interference, and depressive symptoms at 3 and 6 months posttreatment compared with ED. No significant differences on outcomes between HYP and MM were detected at any time point. This study suggests that all 3 interventions provide posttreatment benefits on a range of outcomes, but the benefits of HYP and MM continue beyond the end of treatment, while the improvements associated with ED dissipate over time. Future research is needed to determine whether the between-group differences that emerged posttreatment are reliable, whether there are benefits of combining treatments, and to explore moderating and mediating factors.

The effect of reinforcing an educational programme using telephone follow-up on health-related quality of life of individuals using warfarin: A randomised controlled trial.

OBJECTIVES: To evaluate the effect of reinforcing an educational programme through telephone follow-up on health-related quality of life and anxiety and depression symptoms in individuals starting warfarin therapy. BACKGROUND: Educational interventions have improved quality of life in individuals using warfarin. Few studies have examined the addition of telephone follow-up to enhance educational interventions. DESIGN: Randomised controlled trial in outpatient setting. METHODS: Hospitalised adults starting warfarin therapy who agreed to participate received an educational programme about the warfarin treatment. At discharge, they were randomised to receive either five telephone follow-up calls (intervention) or no telephone calls (controls). Both groups were evaluated for health-related quality of life (using Duke Anticoagulation Satisfaction Scale) and symptoms of anxiety and depression (using Hospital Anxiety and Depression Scale) at three and six months post-discharge. Groups were compared at each time by independent-samples t test, and over time by repeated-measures analysis of variance, with time (three and six months), groups (intervention and control) and an interaction between time and group as factors. Level of significance was set at 0.05. The Consolidated Standards of Reporting Trials was used for reporting. RESULTS: Fifty-two individuals (26 per group) completed the study. There were no statistical differences between groups in health-related quality of life, anxiety and depression symptoms, at both times post-discharge. Participants who received follow-up telephone calls reported better positive psychological impact (a subscale of quality of life) than controls. CONCLUSIONS: Reinforcing an educational programme with telephone follow-ups did not have an overall effect on health-related quality of life of individuals using warfarin but promoted positive psychological impact. RELEVANCE TO CLINICAL PRACTICE: The low cost of reinforcing educational programmes with telephone calls and the improvement in positive psychological aspects indicate that this type of intervention is still a promising intervention that could be further investigated and improved.

Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial.

Moderate to severe traumatic brain injury (TBI) is a common cause of long-term disability. Due to challenges that include inconsistent access to follow-up care, persons with TBI being discharged from inpatient rehabilitation facilities (IRFs) are at risk for rehospitalization, poor reintegration into the community, family stress, and other unfavorable outcomes resulting from unmet needs. In a six-center randomized pragmatic comparative effectiveness study, the BRITE trial (Brain Injury Rehabilitation: Improving the Transition Experience, ClinicalTrials.govNCT03422276), we compare the effectiveness of two existing methods for transition from IRF to community living or long-term nursing care. The Rehabilitation Discharge Plan (RDP) includes patient/family education and referrals for continued care. The Rehabilitation Transition Plan (RTP) provides RDP plus individualized, manualized care management via phone or videoconference, for 6 months. Nine hundred patients will be randomized (1:1) to RDP or RTP, with caregivers also invited to participate and contribute caregiver-reported outcomes. Extensive stakeholder input, including active participation of persons with TBI and their families, has informed all aspects of trial design and implementation planning. We hypothesize that RTP will result in better patient- and caregiver-reported outcomes (societal participation, quality of life, caregiver well-being) and more efficient use of healthcare resources at 6-months (primary outcome) and 12-months post-discharge, compared to RDP alone. Planned analyses will explore which participants benefit most from each transition model. With few exclusion criteria and other pragmatic features, the findings of this trial are expected to have a broad impact on improving transitions from inpatient TBI rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03422276.

Pain-related beliefs, cognitive processes, and electroencephalography band power as predictors and mediators of the effects of psychological chronic pain interventions.

ABSTRACT: The current study used data from a clinical trial to identify variables that are associated with and/or mediate the beneficial effects of 4 psychological chronic pain treatments: one teaching patients self-hypnosis to reduce pain intensity (HYP), one teaching self-hypnosis to change thoughts about pain (hypnotic cognitive therapy [HYP-CT]), one teaching cognitive restructuring skills to change thoughts about pain (cognitive therapy [CT]), and one providing education about pain (ED; included as an active control condition). Of 17 possible mechanism variables examined, and with alpha not corrected for multiple comparisons, significant between-group differences were observed for 3. Two of these (changes in beliefs about control over pain and number of days of skill practice) were supported as mediators of the beneficial effects of HYP, CT, or HYP-CT, relative to ED. Six mechanism variables evidenced significant pretreatment to post-treatment changes in the sample as a whole, without showing significant between-group differences. Pretreatment to post-treatment changes in all 6 were associated with improvements in pain interference, pain intensity, or both. In addition, participant ratings of therapeutic alliance at post-treatment were associated significantly with improvements in both pain intensity and pain interference in the sample as a whole. Thus, of the 17 possible mediators examined, there were relatively few that served as mediators for the beneficial effects of specific treatments; a larger number of variables predicted treatment outcome overall. The extent to which these variables are treatment mediators (ie, are responsible for, rather than merely associated with, treatment-related improvements) will require further research.

Impact of replacing powdered gloves with powder-free gloves on hand-hygiene compliance among healthcare workers of an intensive care unit: a quasi-experimental study.

BACKGROUND/OBJECTIVE: After wearing powdered gloves, healthcare workers (HCW) are supposed to wash their hands instead of using alcohol-based hand-rub (ABHR). Washing hands takes longer than using ABHR, and the use of powdered gloves may be an obstacle to hand-hygiene compliance. This study aimed to evaluate the impact of replacing powdered gloves with powder-free gloves on hand-hygiene compliance among HCW of an intensive care unit (ICU). METHODS: A quasi-experimental study was conducted in a general ICU of a tertiary care university hospital in Brazil. From June 1st to July 15th, 2017, all HCW were provided with powdered latex gloves only for all clinical procedures. From July 15th to August 31st, 2017, HCW were provided with nitrile powder-free gloves only. Hand-hygiene compliance was assessed through direct observation, and evaluated according to the World Health Organization Hand Hygiene guidelines. We calculated that a sample size of 544 hand hygiene opportunities needed to be observed per period. Data analysis were performed using the STATA SE® version 14, and we compared the individual's percentage of compliance using the t test for paired data before and after the intervention. RESULTS: Overall, 40 HCW were assessed before and after the introduction of nitrile powder-free gloves, with 1114 and 1139 observations of hand hygiene opportunities, respectively. The proportion of compliance with hand hygiene was 55% (95% confidence interval [CI] 51-59%) using powdered latex gloves and 60% (95% CI 57-63%) using powder-free gloves. The difference in proportions between the two types of gloves was 5.1% (95% CI 2.5-7.6%, p < 0.001). CONCLUSION: Our data indicate that replacing powdered gloves with powder-free gloves positively influenced hand-hygiene compliance by HCW in an ICU setting.

Chamomile Gel versus Urea Cream to Prevent Acute Radiation Dermatitis in Head and Neck Cancer Patients: Results from a Preliminary Clinical Trial.

We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.

Effects of hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education in adults with chronic pain: a randomized clinical trial.

Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of 4 treatment sessions each of 4 nonpharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive 4 sessions of 1 of the 4 treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pretreatment, posttreatment, and 3-, 6-, and 12-month follow-up. Treatment effects were evaluated using analysis of variance, a generalized estimating equation approach, or a Fisher exact test, depending on the outcome domain examined. All 4 treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months posttreatment. Pretreatment to posttreatment improvements were observed across the 4 treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pretreatment levels at 12-month follow-up. No significant between-group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the 2 significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine whether the significant differences that emerged are reliable.

The use of mentholated popsicle to reduce thirst during preoperative fasting: A randomised controlled trial.

AIMS AND OBJECTIVES: To compare mentholated popsicle with usual care (absolute fasting) in the change of thirst intensity and discomfort of patients in the preoperative fasting. BACKGROUND: Thirst is defined as the desire to drink water, and it is considered to be a multifactorial symptom. In the preoperative fasting, the patient may experience intense thirst, often for a long time, that can lead to feelings of suffocation, desperation, fear and anxiety. DESIGN: A randomised controlled trial. METHODS: Forty patients, aged between 18-60 years, were randomised to mentholated popsicle group or absolute fasting group (twenty in each). The primary outcomes were thirst intensity, evaluated by a numeric scale ranging from 0 (no thirst)-10 (the worst possible thirst), and discomfort from thirst (evaluated by the Perioperative Thirst Discomfort Scale), both measured twice (baseline and after 20 min of intervention). The CONSORT checklist was used to report this study. RESULTS: Mean age was similar in both groups (38 years in the mentholated popsicle group and 39 in the absolute fasting group). At baseline, the mentholated popsicle group had higher median for the scales of intensity (6.5) and discomfort (7.5) from thirst than the absolute fasting group (5.0 and 5.0, respectively). At the end of 20 min, the popsicle group had a statistically significant decrease in intensity and discomfort from thirst (median decreases of 5.0 and 7.0 points, respectively) when compared to the absolute fasting group (median increases of 0.5 and 1.0 points, respectively). CONCLUSIONS: The use of mentholated popsicle decreased the intensity and discomfort from thirst, and it is a viable strategy for the management of thirst in the preoperative fasting. RELEVANCE TO CLINICAL PRACTICE: In the preoperative fasting, making mentholated popsicles available to patients is an easy strategy to manage thirst, which might lead to better care.

Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol.

BACKGROUND: Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments' outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. METHODS: We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. DISCUSSION: Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.