Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review.

OBJECTIVES: Despite the known adverse effects of sleep deprivation on recovery from illness, studies have shown that sleep deprivation remains an incompletely addressed problem among acutely ill inpatients. Behavioral interventions are recommended as first-line therapy prior to using pharmacologic therapy due to the side effects of sedative hypnotics. The objective of this systematic review was to identify non-pharmacologic interventions that have been used to improve sleep quality and quantity of non-intensive care unit (ICU) inpatients. DATA SOURCES: PubMed, Embase, Web of Science, CINAHL, and Cochrane Library through January 2013; manual searches of reference lists. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, INTERVENTIONS: Any study in which a non-pharmacologic intervention was conducted in a general inpatient setting, and nighttime sleep quantity or quality was assessed. STUDY APPRAISAL AND SYNTHESIS METHODS: Information on study design, populations, interventions, comparators, outcomes, time frame, and risk of bias were independently abstracted by two investigators. RESULTS: 13 intervention studies with 1,154 participants were included. Four studies were randomized controlled trials. Seven studies had a low to medium risk of bias, and there was significant heterogeneity in the interventions. Relaxation techniques improved sleep quality 0-38%, interventions to improve sleep hygiene or reduce sleep interruptions improved sleep quantity 5%, and daytime bright light exposure improved sleep quantity 7-18%. LIMITATIONS: The heterogeneity in the types and dose of interventions, outcome measures, length of follow-up, differences in patient populations, and dearth of randomized trials may dilute effects seen or make it more difficult to draw conclusions. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: There is insufficient to low strength of evidence that any non-pharmacologic intervention improves sleep quality or quantity of general inpatients. Further studies are needed in this area to guide clinicians.

Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.

Objectives: Preventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine. Method: An unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of sitting meditation. Participants with chronic or episodic migraine were enrolled and followed for 1 year. The primary outcome was a change in mean monthly migraine days at 12 months from baseline. Secondary outcomes included headache frequency and intensity, acute medication use, work days missed, home meditation, sleep quality, general health, quality of life, migraine impact, positive and negative affect, perceived stress, mindfulness, and pain catastrophizing. Results: Three hundred people were screened and 58 (19%) agreed to participate and enrolled in the intensive meditation training. Forty-six participants with chronic migraine (≥ 15 headaches/month of which ≥ 8 were migraines) and 12 with episodic migraine (< 15 and ≥ 4 migraines/month) attended and 45 (78%) completed the retreat. At 12 months, the average migraine frequency was reduced by 2.7 days (from 16.6 at baseline) per 28 days (95%CI - 4.3, - 1.3) and headaches by 3.4 (20.1 at baseline) per 28 days (- 4.9, - 1.9). Fifty percent responder rate was 29% for migraine. Acute medication use dropped by an average of 2.2 days (- 3.9, - 0.5) per 28 days, and participants reported 2.3 fewer days (- 4.0, - 0.5) on which they reduced their activity due to migraines. The most striking and promising effects were in several secondary outcomes, including migraine-specific quality of life, pain catastrophizing, and perceived stress. The significant improvements observed immediately following the intervention were sustained at 12 months follow-up. Conclusions: Training in Vipassana meditation via a 10-day retreat may reduce the frequency and burden of migraine. Preregistration: ClinicalTrials.gov: NCT00663585.

Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial.

ABSTRACT: Patients with migraine suffer from high morbidity related to the repeated headache attacks, characteristic of the disorder, poor sleep, and a high prevalence of comorbid psychosocial disorders. Current pharmacological therapies do not address these aspects of migraine, but nonpharmacological treatments such as mindfulness-based stress reduction (MBSR) have been shown to improve both pain and psychological well-being. In this secondary analysis, we examined the change over time in sleep quality and psychosocial outcomes from the magnetic resonance imaging outcomes for mindfulness meditation clinical trial and assessed how these mediated treatment response (50% reduction in headache frequency postintervention). We also examined the relationship between baseline values and treatment response. The trial (primary outcomes previously reported) included 98 patients with episodic migraine randomized to either enhanced MBSR (MBSR+) or stress management for headache. They completed psychosocial questionnaires and headache diaries at baseline (preintervention), midintervention (10 weeks after baseline), and postintervention (20 weeks after baseline). There was a significant improvement in sleep quality from baseline to postintervention (P = 0.0025) in both groups. There were no significant changes from baseline or between groups in anxiety, depression, and stress. There was also no significant association between baseline scores and treatment response. Mediation analysis showed a significant indirect effect of 6% for sleep: In other words, small improvements in sleep may have contributed to the efficacy of MBSR+.Trial registration: NCT02133209.

Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes.

We aimed to evaluate the efficacy of an enhanced mindfulness-based stress reduction (MBSR+) vs stress management for headache (SMH). We performed a randomized, assessor-blind, clinical trial of 98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n = 50) with SMH (n = 48). MBSR+ and SMH were delivered weekly by group for 8 weeks, then biweekly for another 8 weeks. The primary clinical outcome was reduction in headache days from baseline to 20 weeks. Magnetic resonance imaging (MRI) outcomes included activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula to DLPFC and cognitive task network, and gray matter volume of DLPFC, dorsal anterior insula, and anterior midcingulate. Secondary outcomes were headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses. Reduction in headache days from baseline to 20 weeks was greater for MBSR+ (7.8 [95% CI, 6.9-8.8] to 4.6 [95% CI, 3.7-5.6]) than for SMH (7.7 [95% CI 6.7-8.7] to 6.0 [95% CI, 4.9-7.0]) (P = 0.04). Fifty-two percent of the MBSR+ group showed a response to treatment (50% reduction in headache days) compared with 23% in the SMH group (P = 0.004). Reduction in headache-related disability was greater for MBSR+ (59.6 [95% CI, 57.9-61.3] to 54.6 [95% CI, 52.9-56.4]) than SMH (59.6 [95% CI, 57.7-61.5] to 57.5 [95% CI, 55.5-59.4]) (P = 0.02). There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed. Enhanced mindfulness-based stress reduction is an effective treatment option for episodic migraine.

Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

CONTEXT: A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. OBJECTIVE: To determine the impact of informing resource-poor rural populations about entitled services. DESIGN, SETTING, AND PARTICIPANTS: Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. INTERVENTION: Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. MAIN OUTCOME MEASURES: Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. RESULTS: At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P < .001), 27% more tetanus vaccinations (95% CI, 12%-41%; P < .001), 24% more prenatal supplements (95% CI, 8%-39%; P = .003), 25% more infant vaccinations (95% CI, 8%-42%; P = .004), and decreased excess school fees of 8 rupees (95% CI, 4-13 rupees; P < .001). In a difference-in-differences analysis, 21% more village council meetings were reported (95% CI, 5%-36%; P = .01). There were no improvements in visits by a nurse midwife or in development work in the villages. Both low-caste and mid- to high-caste intervention households reported significant improvements in service delivery. CONCLUSIONS: Informing resource-poor rural populations in India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00421291.

High Frequency Migraine Is Associated with Lower Acute Pain Sensitivity and Abnormal Insula Activity Related to Migraine Pain Intensity, Attack Frequency, and Pain Catastrophizing.

Migraine is a pain disorder associated with abnormal brain structure and function, yet the effect of migraine on acute pain processing remains unclear. It also remains unclear whether altered pain-related brain responses and related structural changes are associated with clinical migraine characteristics. Using fMRI and three levels of thermal stimuli (non-painful, mildly painful, and moderately painful), we compared whole-brain activity between 14 migraine patients and 14 matched controls. Although, there were no significant differences in pain thresholds nor in pre-scan pain ratings to mildly painful thermal stimuli, patients did have aberrant suprathreshold nociceptive processing. Brain imaging showed that, compared to controls, patients had reduced activity in pain modulatory regions including left dorsolateral prefrontal, posterior parietal, and middle temporal cortices and, at a lower-threshold, greater activation in the right mid-insula to moderate pain vs. mild pain. We also found that pain-related activity in the insula was associated with clinical variables in patients, including associations between: bilateral anterior insula and pain catastrophizing (PCS); bilateral anterior insula and contralateral posterior insula and migraine pain intensity; and bilateral posterior insula and migraine frequency at a lower-threshold. PCS and migraine pain intensity were also negatively associated with activity in midline regions including posterior cingulate and medial prefrontal cortices. Diffusion tensor imaging revealed a negative correlation between fractional anisotropy (a measure of white matter integrity; FA) and migraine duration in the right mid-insula and a positive correlation between left mid-insula FA and PCS. In sum, while patients showed lower sensitivity to acute noxious stimuli, the neuroimaging findings suggest enhanced nociceptive processing and significantly disrupted modulatory networks, particularly involving the insula, associated with indices of disease severity in migraine.

Altered cognition-related brain activity and interactions with acute pain in migraine.

Little is known about the effect of migraine on neural cognitive networks. However, cognitive dysfunction is increasingly being recognized as a comorbidity of chronic pain. Pain appears to affect cognitive ability and the function of cognitive networks over time, and decrements in cognitive function can exacerbate affective and sensory components of pain. We investigated differences in cognitive processing and pain-cognition interactions between 14 migraine patients and 14 matched healthy controls using an fMRI block-design with two levels of task difficulty and concurrent heat (painful and not painful) stimuli. Across groups, cognitive networks were recruited in response to a difficult cognitive task, and a pain-task interaction was found in the right (contralateral to pain stimulus) posterior insula (pINS), such that activity was modulated by decreasing the thermal pain stimulus or by engaging the difficult cognitive task. Migraine patients had less task-related deactivation within the left dorsolateral prefrontal cortex (DLPFC) and left dorsal anterior midcingulate cortex (aMCC) compared to controls. These regions have been reported to have decreased cortical thickness and cognitive-related deactivation within other pain populations, and are also associated with pain regulation, suggesting that the current findings may reflect altered cognitive function and top-down regulation of pain. During pain conditions, patients had decreased task-related activity, but more widespread task-related reductions in pain-related activity, compared to controls, suggesting cognitive resources may be diverted from task-related to pain-reduction-related processes in migraine. Overall, these findings suggest that migraine is associated with altered cognitive-related neural activity, which may reflect altered pain regulatory processes as well as broader functional restructuring.

Altered Brain Structure and Function Correlate with Disease Severity and Pain Catastrophizing in Migraine Patients.

To investigate the neuroanatomical and functional brain changes in migraine patients relative to healthy controls, we used a combined analytical approach including voxel- and surface-based morphometry along with resting-state functional connectivity to determine whether areas showing structural alterations in patients also showed abnormal functional connectivity. Additionally, we wanted to assess whether these structural and functional changes were associated with group differences in pain catastrophizing and migraine-related disease variables in patients. We acquired T1-weighted anatomical and functional magnetic resonance imaging scans during rest in human subjects with a diagnosis of migraine and healthy controls. Structural analyses revealed greater left hippocampal gray matter volume and reduced cortical thickness in the left anterior midcingulate in patients compared with controls. We also observed negative associations between pain catastrophizing and migraine disease variables and gray matter in areas implicated in processing the sensory, affective, and cognitive aspects of pain in patients. Functional connectivity analyses showed that migraine patients displayed disrupted connectivity between default mode, salience, cognitive, visuospatial, and sensorimotor networks, which was associated with group differences in pain catastrophizing and migraine-related disease variables in patients. Together, our findings show widespread morphological and functional brain abnormalities in migraineurs in affective, cognitive, visual, and pain-related brain areas, which are associated with increased pain catastrophizing, disease chronicity, and severity of symptoms, suggesting that these structural and functional changes may be a consequence of repeated, long-term nociceptive signaling leading to increased pain sensitivity, mood disturbances, and maladaptive coping strategies to deal with unrelenting pain.

Meditation programs for psychological stress and well-being: a systematic review and meta-analysis.

IMPORTANCE: Many people meditate to reduce psychological stress and stress-related health problems. To counsel people appropriately, clinicians need to know what the evidence says about the health benefits of meditation. OBJECTIVE: To determine the efficacy of meditation programs in improving stress-related outcomes (anxiety, depression, stress/distress, positive mood, mental health-related quality of life, attention, substance use, eating habits, sleep, pain, and weight) in diverse adult clinical populations. EVIDENCE REVIEW: We identified randomized clinical trials with active controls for placebo effects through November 2012 from MEDLINE, PsycINFO, EMBASE, PsycArticles, Scopus, CINAHL, AMED, the Cochrane Library, and hand searches. Two independent reviewers screened citations and extracted data. We graded the strength of evidence using 4 domains (risk of bias, precision, directness, and consistency) and determined the magnitude and direction of effect by calculating the relative difference between groups in change from baseline. When possible, we conducted meta-analyses using standardized mean differences to obtain aggregate estimates of effect size with 95% confidence intervals. FINDINGS: After reviewing 18 753 citations, we included 47 trials with 3515 participants. Mindfulness meditation programs had moderate evidence of improved anxiety (effect size, 0.38 [95% CI, 0.12-0.64] at 8 weeks and 0.22 [0.02-0.43] at 3-6 months), depression (0.30 [0.00-0.59] at 8 weeks and 0.23 [0.05-0.42] at 3-6 months), and pain (0.33 [0.03- 0.62]) and low evidence of improved stress/distress and mental health-related quality of life. We found low evidence of no effect or insufficient evidence of any effect of meditation programs on positive mood, attention, substance use, eating habits, sleep, and weight. We found no evidence that meditation programs were better than any active treatment (ie, drugs, exercise, and other behavioral therapies). CONCLUSIONS AND RELEVANCE: Clinicians should be aware that meditation programs can result in small to moderate reductions of multiple negative dimensions of psychological stress. Thus, clinicians should be prepared to talk with their patients about the role that a meditation program could have in addressing psychological stress. Stronger study designs are needed to determine the effects of meditation programs in improving the positive dimensions of mental health and stress-related behavior.

Intensive meditation for refractory pain and symptoms.

OBJECTIVE: The objective of this study was to assess patient interest in intensive meditation training for chronic symptoms. DESIGN AND SETTING: This was a cross-sectional anonymous survey among six chronic disease clinics in Baltimore including Chronic Kidney Disease, Crohn's Disease, Headache, Renal Transplant Recipients, General Rheumatology, and lupus clinic. SUBJECTS: Subjects were 1119 consecutive patients registering for their appointments at these clinics. OUTCOME MEASURES: Outcome measures were 6-month pain, global symptomatology, four-item perceived stress scale, use of complementary and alternative medicine (CAM) therapies, and attitudes toward use of meditation for managing symptoms. We then gave a scripted description of an intensive, 10-day meditation training retreat. Patient interest in attending such a retreat was assessed. RESULTS: Seventy-seven percent (77%) of patients approached completed the survey. Fifty-three percent (53%) of patients reported moderate to severe pain over the past 6 months. Eighty percent (80%) reported use of some CAM therapy in the past. Thirty-five percent (35%) thought that learning meditation would improve their health, and 49% thought it would reduce stress. Overall, 39% reported interest in attending the intensive 10-day meditation retreat. Among those reporting moderate to severe pain or stress, the percentages were higher (48% and 59%). In a univariate analysis, higher education, nonworking/disabled status, female gender, higher stress, higher pain, higher symptomatology, and any CAM use were all associated with a greater odds of being moderately to very interested in an intensive 10-day meditation retreat. A multivariate model that included prior use of CAM therapies as predictors of interest in the program fit the data significantly better than a model not including CAM therapies (p = 0.0013). CONCLUSIONS: Over 50% of patients followed in chronic disease clinics complain of moderate to severe pain. Patients with persistent pain or stress are more likely to be interested in intensive meditation.

Economic and health consequences of selling a kidney in India.

CONTEXT: Many countries have a shortage of kidneys available for transplantation. Paying people to donate kidneys is often proposed or justified as a way to benefit recipients by increasing the supply of organs and to benefit donors by improving their economic status. However, whether individuals who sell their kidneys actually benefit from the sale is controversial. OBJECTIVE: To determine the economic and health effects of selling a kidney. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey conducted in February 2001 among 305 individuals who had sold a kidney in Chennai, India, an average of 6 years before the survey. MAIN OUTCOME MEASURES: Reasons for selling kidney, amount received from sale, how money was spent, change in economic status, change in health status, advice for others contemplating selling a kidney. RESULTS: Ninety-six percent of participants sold their kidneys to pay off debts. The average amount received was 1070 US dollars. Most of the money received was spent on debts, food, and clothing. Average family income declined by one third after nephrectomy (P<.001), and the number of participants living below the poverty line increased. Three fourths of participants were still in debt at the time of the survey. About 86% of participants reported a deterioration in their health status after nephrectomy. Seventy-nine percent would not recommend that others sell a kidney. CONCLUSIONS: Among paid donors in India, selling a kidney does not lead to a long-term economic benefit and may be associated with a decline in health. Physicians and policy makers should reexamine the value of using financial incentives to increase the supply of organs for transplantation.