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Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial.

ABSTRACT: Nightshift working is associated with sleep deprivation, fatigue and attention/concentration deficits which, in healthcare workers, may impact on patient safety. Clinical staff in the UK routinely work several 12 h nightshifts in a row at about 1-3 month intervals. We investigated the feasibility and acceptability of a crossover trial of melatonin administration in clinical staff working nightshifts with an exploration of effects on sleep measures and attention/concentration tasks. This was a pilot, double-blinded, randomized, placebo-controlled crossover feasibility trial in doctors and nurses working 3 consecutive nightshifts at a tertiary referral hospital in the UK. Twenty five male and female subjects were randomized to receive either 6mg Circadin™ slow release melatonin or placebo before sleep after each consecutive nightshift, followed by a washout period, before crossing over to the other experimental arm. We used actigraphy for objective assessment of sleep parameters. The trial design was feasible and acceptable to participants with negligible side effects, but elevated melatonin levels were prolonged during the active arm (P=0.016). Double digit addition testing, a concentration/attention task, improved with melatonin treatment (P<0.0001). Lapses of vigilance or judgement while doctors or nurses are working nightshifts could impact on patient safety and melatonin may be a useful intervention. This study supports the conclusion that a larger definitive trial of this design is both feasible and safe. Clinical Trial Registration: identifier ISRCTN15529655. https://www.isrctn.com/.

SUBMITTER: Thottakam BMVJ

PROVIDER: S-EPMC7481467 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial.

Thottakam Bensita M V J BMVJ Webster Nigel R NR Allen Lee L Columb Malachy O MO Galley Helen F HF

Frontiers in psychiatry 20200827

Nightshift working is associated with sleep deprivation, fatigue and attention/concentration deficits which, in healthcare workers, may impact on patient safety. Clinical staff in the UK routinely work several 12 h nightshifts in a row at about 1-3 month intervals. We investigated the feasibility and acceptability of a crossover trial of melatonin administration in clinical staff working nightshifts with an exploration of effects on sleep measures and attention/concentration tasks. This was a pi ...[more]

PMID: 33192634

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Project description:ObjectiveAlthough mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy.Design26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone.SettingOutpatient.PatientsAdults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer.InterventionsTargeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. "Usual care" for opioid-treated CLBP was provided to participants by their regular clinicians.Outcome measuresFeasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants.ResultsThirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants.ConclusionsMM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.

Project description:IntroductionChildren with autism spectrum disorder (ASD) benefit when their caregivers can effectively advocate for appropriate services. Barriers to caregiver engagement such as provider mistrust, cultural differences, stigma, and lack of knowledge can interfere with timely service access. We describe Mind the Gap (MTG), an intervention that provides education about ASD, service navigation, and other topics relevant to families whose children have a new ASD diagnosis. MTG was developed via community partnerships and is explicitly structured to reduce engagement barriers (e.g., through peer matching, meeting flexibility, culturally-informed practices). We also present on the results of a pilot of MTG, conducted in preparation for a randomized controlled trial.MethodsMTG was evaluated using mixed methods that included qualitative analysis and pre/post-test without concurrent comparison group. Participants (n=9) were primary caregivers of children (ages 2-7 years) with a recent ASD diagnosis and whose annual income was at or below 185% of the federal poverty level. In order to facilitate trust and relationship building, peer coaches delivered MTG. The coaches were parents of children with ASD who we trained to deliver the intervention. MTG consisted of up to 12 meetings between coaches and caregivers over the course of 18 weeks. Coaches delivered the intervention in homes and other community locations. Coaches shared information about various "modules," which were topics identified as important for families with a new ASD diagnosis. Coaches worked with families to answer questions, set weekly goals, assess progress, and offer guidance. For the pilot, we focused on three primary outcomes: feasibility, engagement, and satisfaction. Feasibility was measured via enrollment and retention data, as well as coach fidelity (i.e., implementation of MTG procedures). Engagement was measured via number of sessions attended and percentage completion of the selected outcome measures. For completers (n=7), satisfaction was measured via a questionnaire (completed by caregivers) and open-ended interviews (completed by caregivers and coaches).ResultsWe enrolled 56% of referred caregivers and 100% of eligible families. Retention was high (78%). Coaches could deliver the intervention with fidelity, completing, on average, 83% of program components. Engagement also was high; caregivers attended an average of 85% of total possible sessions and completed 100% of their measures. Caregivers indicated moderately high satisfaction with MTG. Qualitative data indicated that caregivers and coaches were positive about intervention content, and the coach-caregiver relationship was important. They also had suggestions for changes.ConclusionMind the Gap demonstrates evidence of feasibility, and data from the pilot suggest that it addresses intervention engagement barriers for a population that is under-represented in research. The results and suggestions from participants were used to inform a large-scale RCT, which is currently underway. Overall, MTG shows promise as an intervention that can be feasibly implemented with under-resourced and ethnic minority families of children with ASD.Trial registrationThis study is registered with ClinicalTrials.gov: NCT03711799.

Project description:PurposeOngoing symptoms and impairments in quality of life (QOL) among breast cancer survivors remain a significant problem. We tested the feasibility and acceptability of a manualized Ayurvedic nutrition and lifestyle intervention for breast cancer survivors.MethodsEligible participants had Stage I-III breast cancer, underwent treatment within the past year that included chemotherapy, and were without active disease. The 4-month individualized Ayurvedic intervention included counseling on nutrition, lifestyle, yoga, and marma (like acupressure) during 8 one-on-one visits with an Ayurvedic practitioner. Feasibility and acceptability were the primary outcomes. QOL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C30]) and symptoms-sleep disturbance (General Sleep Disturbance Scale [GSDS]), fatigue (Lee Fatigue Scale [LFS]), depressive symptoms (Center for Epidemiological Studies-Depression Scale [CES-D]), anxiety (Spielberger State-Trait Anxiety Inventory [STAI-S, STAI-T]), and stress (Perceived Stress Scale [PSS])-were measured prior to, at midpoint, and at the end of the 4-month intervention. Effect sizes (Cohen's d) were calculated along with paired t tests comparing baseline to end of month 4 time points. Mixed effects models were used for repeated measures analyses.ResultsParticipants (n?=?32) had a mean age of 48?years (SD?=?10). Retention at the end of the intervention was 84%. Among those who completed the intervention (n?=?27), adherence was high (99.5% of visits with practitioners attended). Large improvements were seen in QLQ-C30 emotional functioning (d?=?0.84, P?<?0.001), QLQ-C30 cognitive functioning (d?=?0.86, P?<?0.001), GSDS (d?=?-1.23, P?<?0.001), and CES-D (d?=?-1.21, P?<?0.001). Moderate improvements were seen in QLQ-C30 global health (d?=?0.65, p?=?0.003), LFS (d?=?-0.68, P?=?0.002), and PSS (d?=?-0.75, P?<?0.001). No adverse events were observed due to the intervention.ConclusionThis 4-month Ayurvedic whole-systems multimodal nutrition and lifestyle intervention was feasible and acceptable for breast cancer survivors. Promise of clinical benefit was seen in terms of improvements in symptoms and QOL that warrants further investigation.

Project description:BackgroundThe World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion.MethodsThe aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother's groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen's d statistic.ResultsRecruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen's d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants.ConclusionGroup tummy time classes delivered in a mother's group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted.Trial registrationANZCTR, ACTRN12617001298303p. Registered 11 September 2017.

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Project description:OBJECTIVES:(1) Assess whether cardiac rehabilitation (CR) is a feasible and acceptable model of rehabilitation for postsurgical colorectal cancer (CRC) survivors, (2) evaluate trial procedures. This article reports the results of the first objective. DESIGN AND SETTING:A pragmatic pilot randomised controlled trial with embedded qualitative study was conducted in 3 UK hospitals with CR facilities. Descriptive statistics were used to summarise trial parameters indicative of intervention feasibility and acceptability. Interviews and focus groups were conducted and data analysed thematically. PARTICIPANTS:People with CRC were considered for inclusion in the trial if they were ? 18 years old, diagnosed with primary CRC and in the recovery period postsurgery (they could still be receiving adjuvant therapy). 31% (n=41) of all eligible CRC survivors consented to participate in the trial. 22 of these CRC survivors, and 8 people with cardiovascular disease (CVD), 5 CRC nurses and 6 CR clinicians participated in the qualitative study. INTERVENTION:Referral of postsurgical CRC survivors to weekly CR exercise classes and information sessions. Classes included CRC survivors and people with CVD. CR nurses and physiotherapists were given training about cancer and exercise. RESULTS:Barriers to CR were protracted recoveries from surgery, ongoing treatments and poor mobility. No adverse events were reported during the trial, suggesting that CR is safe. 62% of participants completed the intervention as per protocol and had high levels of attendance. 20 health professionals attended the cancer and exercise training course, rating it as excellent. Participants perceived that CR increased CRC survivors' confidence and motivation to exercise, and offered peer support. CR professionals were concerned about CR capacity to accommodate cancer survivors and their ability to provide psychosocial support to this group of patients. CONCLUSIONS:CR is feasible and acceptable for postsurgical CRC survivors. A large-scale effectiveness trial of the intervention should be conducted. TRIAL REGISTRATION NUMBER:ISRCTN63510637.

Dataset Information

Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial.

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Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial.

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