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Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial.

ABSTRACT: Background: Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will assess the influence of specific variables that could modify these effects, analyse the correlates related to nocturnal wakefulness and consider the diurnal consequences according to the sleep characteristics identified.

Methods: This single-blind, multicentre, randomised clinical trial will focus on informal providers of care for cancer patients. Two samples of 40 caregivers will be recruited. The first, intervention, group will receive seven music-based sessions. The control group will be masked with seven sessions of therapeutic education (reinforcing previous sessions). Outcomes will be evaluated using the Pittsburgh Sleep Quality Index, a triaxial accelerometer, EuroQol-5D-5L, the Caregiver Strain Index, the Epworth Sleepiness Scale and the Client Satisfaction Questionnaire. The caregivers' satisfaction with the intervention performed will also be examined.

Discussion: This study is expected to extend our understanding of the efficacy of music therapy in enhancing the sleep quality of caregivers for patients receiving home palliative care. To our knowledge, no reliable scientific investigations of this subject have previously been undertaken. Music is believed to benefit certain aspects of sleep, but this has yet to be proven and, according to a Cochrane review, high-quality research in this field is necessary. One of the main strengths of our study, which heightens the quality of the randomised clinical trial design, is the objective assessment of physical activity by accelerometry and the use of both objective and subjective measures of sleep in caregivers. Music therapy for the caregivers addressed in this study is complementary, readily applicable, provokes no harmful side effects and may produce significant benefits.

Trial registration: The IMECA study is registered at Clinical Trials.gov, ClinicalTrials.gov Identifier: NCT04491110 . Registered 29 July, 2020.

SUBMITTER: Valero-Cantero I

PROVIDER: S-EPMC7670676 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial.

Valero-Cantero Inmaculada I Carrión-Velasco Yolanda Y Casals Cristina C Martínez-Valero Francisco Javier FJ Barón-López Francisco Javier FJ Vázquez-Sánchez María Ángeles MÁ

BMC nursing 20201116 1

<h4>Background</h4>Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will as ...[more]

PMID: 33292183

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Project description:Background Perceived stress, burnout, and poor sleep quality are high among medical students. Interventions designed to target these issues are necessary to promote the health and well-being of medical students. The purpose of this study was twofold: 1) to assess the feasibility of implementing a sunrise alarm clock intervention with medical students and 2) to evaluate the impact of the intervention on perceived stress, burnout scores, and sleep quality. Methods We conducted a feasibility study to evaluate the efficacy of a two-week, sunrise alarm clock intervention in combination with electronic device removal at bedtime. We assessed first- and second-year medical students’ perceived stress, burnout scores, including Emotional Exhaustion, Depersonalization, and Low Sense of Personal Achievement, and sleep quality before and after the intervention. In addition, we measured smartphone addiction prior to the intervention. Results A total of 57 students consented to participate, of which 55 completed both the pre- and post-assessments (3.5% attrition). The mean age of the participants was 24.8?±?1.9?years, 50.9% (n =?29) identified as women, and 68.4% (n =?39) identified as white. Pre-intervention, 42.1% (n =?24) of students met criteria for smartphone addiction and 77.2% (n =?44) met criteria for poor sleep quality. In addition, 22.8% (n =?13) of participants had high emotional exhaustion, 64.9% (n =?31) high depersonalization, and 42.1% (n =?24) low sense of personal accomplishment prior to the intervention. Following the two-week intervention, participants showed improvements in emotional exhaustion (p =?0.001, Cohen’s d?=?0.353), depersonalization (p?=?0.001, Cohen’s d?=?0.411) low sense of personal accomplishment (p =?0.023, Cohen’s d?=?0.275), perceived stress (p <?.001, Cohen’s d?=?.334), and sleep quality (p <?0.001, Cohen’s d?=?0.925). The number of participants who reported poor sleep quality decreased to 41.8% (n =?23), demonstrating a significant decline (p =?0.026). Participants also improved subjective sleep quality (p <?0.001, Cohen’s d?=?1.033), sleep duration (p =?0.001, Cohen’s d?=?0.431), sleep latency (p?<?0.001, Cohen’s d?=?0.433), and sleep efficiency (p =?0.021, Cohen’s d?=?0.673). Conclusions These findings suggest that the two-week sunrise alarm clock protocol with electronic device removal was effective in improving sleep quality and reducing burnout scores, and perceived stress. However, additional research comparing this intervention to a proper control group is needed to draw meaningful conclusions about the effectiveness of this intervention.

Project description:IntroductionAdolescents with attention deficit hyperactivity disorder (ADHD) experience a more disrupted sleep and more sleep problems compared with typically developing adolescents. This is particularly concerning, because disrupted sleep is related to worsened clinical, neurocognitive and functional outcomes and leads to increased ADHD symptom impairment. Due to the specific difficulties adolescents with ADHD experience, a tailored sleep treatment is needed. Therefore, our lab developed a cognitive behavioural treatment-Sleep IntervEntion as Sympom Treatment for ADHD (SIESTA)-that integrates sleep training with motivational interviewing, and planning/organisational skills training with the aim of improving sleep problems in adolescents with ADHD.Methods and analysisA randomised, controlled, investigator-blinded monocentre trial is used to test whether SIESTA in combination with treatment as usual (TAU) for ADHD results in greater improvement in sleep problems than TAU only. Adolescents (aged 13-17 years) with ADHD and sleep problems are included. They complete measurements before treatment (pre-test), approximately 7 weeks after the pre-test (post-test), and approximately 3 months after the post-test (follow-up). The assessment includes questionnaires filled out by adolescents, parents and teachers. Additionally, sleep is assessed by actigraphy and sleep diaries at all time-points. Primary outcomes include objectively and subjectively measured sleep architecture (specified as total sleep time, sleep onset latency, sleep efficiency and number of awakenings), subjectively measured sleep problems and sleep hygiene. Secondary outcomes include ADHD symptoms, comorbidities and functional outcomes. To analyse the data, a linear mixed effects model will be used with an intent-to-treat approach.Ethics and disseminationThe study activities, informed consent and assent forms have been approved by the Ethical Committee Research UZ/KU Leuven (study ID S64197). If proven effective, the intervention will be implemented throughout Flanders. Therefore, an advisory board consisting of societal partners in healthcare is appointed at the start of the project, giving advice throughout the project and assistance with implementation afterwards.Trial registration numberNCT04723719.

Project description:BackgroundThere is increasing recognition of the delicate balance between the modest benefits of palliative chemotherapy and the burden of treatment. Decision aids (DAs) can potentially help patients with advanced cancer with these difficult treatment decisions, but providing detailed information could have an adverse impact on patients' well-being. The objective of this randomised phase II study was to evaluate the safety and efficacy of DAs for patients with advanced cancer considering second-line chemotherapy.MethodsPatients with advanced breast or colorectal cancer considering second-line treatment were randomly assigned to usual care (control group) or usual care plus a DA (intervention group) in a 1:2 ratio. A nurse offered a DA with information on adverse events, tumour response and survival. Outcome measures included patient-reported well-being (primary outcome: anxiety) and quality of the decision-making process and the resulting choice.ResultsOf 128 patients randomised, 45 were assigned to the control group and 83 to the intervention group. Median age was 62 years (range 32-81), 63% were female, and 73% had colorectal cancer. The large majority of patients preferred treatment with chemotherapy (87%) and subsequently commenced treatment with chemotherapy (86%). No adverse impact on patients' well-being was found and nurses reported that consultations in which the DAs were offered went well. Being offered the DA was associated with stronger treatment preferences (3.0 vs. 2.5; p=0.030) and increased subjective knowledge (6.7 vs. 6.3; p=0.022). Objective knowledge, risk perception and perceived involvement were comparable between the groups.ConclusionsDAs containing detailed risk information on second-line palliative treatment could be delivered to patients with advanced cancer without having an adverse impact on patient well-being. Surprisingly, the DAs only marginally improved the quality of the decision-making process. The effectiveness of DAs for palliative treatment decisions needs further exploration.Trial registrationNetherlands Trial Registry (NTR): NTR1113 (registered on 2 November 2007).

Project description:BackgroundSleep disturbance in older people is an important health issue that is associated with many other health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been suggested as a potential therapeutic technique to improve sleep. The aim of this study is to evaluate the effects of an acupressure intervention on sleep quality, anxiety, depression, and quality of life among older persons in residential aged care facilities within an Australian context.Methods/designThis is a randomised controlled trial with two parallel groups in a pre- and post-test study. Study participants will be older people living in residential aged care facilities. They will be assigned to intervention and control groups using computer-generated random numbers. The intervention group will receive 12-min acupressure three times per week for four consecutive weeks, applied on three acupoints: HT7, PC6, and SP6. The control group will receive only routine care. The primary outcome measure is sleep quality, and secondary outcomes include anxiety, depression, and quality of life. Data will be collected before the intervention, immediately after the end of the intervention, and 2 weeks after the intervention.DiscussionThis study targets a poorly met healthcare need of older people who are experiencing sleep disturbance and its negative consequences. To the researchers' knowledge, this is the first study evaluating acupressure in an Australian aged care context, using specific acupoints and a standardised acupressure protocol. If the results show positive outcomes, acupressure could be used to manage sleep disturbances for older people in the Australian context as well as in the global ageing population. This will contribute to reducing negative consequences of sleep disturbance and use of sleep medications.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12619000262101. Registered on 20 February 2019.

Project description:Objective To evaluate the effectiveness of feedback on safety of prescribing compared with moderately enhanced usual care.Design Three arm, highly pragmatic cluster randomised trial.Setting and participants 262/278 (94%) primary care practices in three Scottish health boards.Interventions Practices were randomised to: "usual care," consisting of emailed educational material with support for searching to identify patients (88 practices at baseline, 86 analysed); usual care plus feedback on practice's high risk prescribing sent quarterly on five occasions (87 practices, 86 analysed); or usual care plus the same feedback incorporating a behavioural change component (87 practices, 86 analysed).Main outcome measures The primary outcome was a patient level composite of six prescribing measures relating to high risk use of antipsychotics, non-steroidal anti-inflammatories, and antiplatelets. Secondary outcomes were the six individual measures. The primary analysis compared high risk prescribing in the two feedback arms against usual care at 15 months. Secondary analyses examined immediate change and change in trend of high risk prescribing associated with implementation of the intervention within each arm.Results In the primary analysis, high risk prescribing as measured by the primary outcome fell from 6.0% (3332/55 896) to 5.1% (2845/55 872) in the usual care arm, compared with 5.9% (3341/56 194) to 4.6% (2587/56 478) in the feedback only arm (odds ratio 0.88 (95% confidence interval 0.80 to 0.96) compared with usual care; P=0.007) and 6.2% (3634/58 569) to 4.6% (2686/58 582) in the feedback plus behavioural change component arm (0.86 (0.78 to 0.95); P=0.002). In the pre-specified secondary analysis of change in trend within each arm, the usual care educational intervention had no effect on the existing declining trend in high risk prescribing. Both types of feedback were associated with significantly more rapid decline in high risk prescribing after the intervention compared with before.Conclusions Feedback of prescribing safety data was effective at reducing high risk prescribing. The intervention would be feasible to implement at scale in contexts where electronic health records are in general use.Trial registration Clinical trials NCT01602705.

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Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial.

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Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial.

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