User Experiences of Ball Blankets in Adults with Depression-Related Insomnia: A Qualitative Content Analysis Study.

Insomnia is prevalent in patients suffering from depression and may itself exacerbate the disability associated with depression and impede the path to recovery. Although crucial in ensuring meaningful interactions and interventions for patients, research on patients' experiences of depression-related insomnia and its treatment is limited. The purpose of this study was therefore to investigate how adult patients with depression-related insomnia experience sleeping with a weighted Protac Ball Blanket®, focusing on how the blanket feels and works and contributes to their subjective sleep quality experience. An inductive content analysis approach was adopted. Semi-structured interviews were conducted with 13 patients. Four categories were identified: 1) Deep and dynamic touch pressure from the plastic balls induced calmness; 2) Changing sensory impressions from the rolling balls distracted attention from distressing thoughts and emotions; 3) The ball blanket improved the quality and quantity of sleep, which increased daily well-being; 4) Sleeping with the ball blanket was associated with positive as well as negative experiences depending on personal preferences for sensory stimulation. This study explains how the Protac Ball Blanket® as a potential non-pharmacological sleep-intervention improved the sleep of adult patients with depression-related insomnia. The blanket was found meaningful for coping with sleeplessness and with mental and physical unrest.

The efficacy of ball blankets on insomnia in depression in outpatient clinics: A randomised crossover multicentre trial.

Many patients with depression report insomnia symptoms that profoundly affect their health and well-being. Non-pharmacological treatments of insomnia may be preferable for some patients. In this randomised crossover trial, we investigated the efficacy of the Protac Ball Blanket® on insomnia among patients with depression. Included patients (n = 45) were diagnosed with unipolar depression, and with subjective insomnia and poor sleep quality (Pittsburgh Sleep Quality Index Score > 5). Each patient slept 2 weeks with a Protac Ball Blanket® and 2 weeks with a control duvet. Randomisation defined the order of the 2-week sleep periods. Patients served as their own control in this design. The primary outcome was changes in total night-time sleep. Secondary outcomes were sleep-onset latency, number of awakenings, wake after sleep onset, daily use of pro necessitate sedatives and hypnotics, subjective sleep quality (Pittsburgh Sleep Quality Index), insomnia severity (Insomnia Severity Index), symptoms of depression (Hamilton Depression Rating Scale, Major Depression Inventory), symptoms of anxiety (Beck Anxiety Index), and patient-reported outcomes concerning interpersonal sensitivity, neurasthenia, anxiety and depression (Self-Reported Symptom State Scale). Paired two-sided t-tests were used to compare the means of the differences of the outcomes. Protac Ball Blanket® increased total night-time sleep by 12.9 min (95% confidence interval: 1.21-24.63, p = 0.031). Among the secondary outcomes, Protac Ball Blanket® decreased Hamilton Depression Rating Scale by 2.78 (95% confidence interval: -5.44; -0.11, p = 0.042) and Insomnia Severity Index by 2.98 (95% confidence interval: -5.45; -0.50, p = 0.020). No changes were observed in sleep-onset latency, number of awakenings, wake after sleep onset, Pittsburgh Sleep Quality Index, Major Depression Inventory, Beck Anxiety Index, Self-Reported Symptom State Scale, and medication use. The results suggest that some patients may benefit from Protac Ball Blanket® as an add-on non-pharmacological treatment to improve sleep in depression.

The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial.

BACKGROUND: Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design. METHODS: This study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence "AB" or "BA" each lasting 4 weeks (28 nights). Patients randomized to the "AB" sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed. DISCUSSION: This clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03730974 . Registered on 5 November 2018.

Perceptions of patients, significant others and health professionals of the role of significant others in programs for chronic non-malignant pain patients: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The objective of this review is to identify and synthesize the perceptions of patients, significant others and health professionals regarding the role of significant others in chronic pain programs or healthcare regimens that target patients with chronic non-malignant pain. More specifically, the objective is to identify the role of significant others in chronic pain programs and healthcare regimens for adult patients with chronic non-malignant pain in primary, secondary or tertiary healthcare settings.

Experiences and management of fatigue in everyday life among adult patients living with heart failure: a systematic review of qualitative evidence.

BACKGROUND: Fatigue, a common and distressing symptom of heart failure, is a non-specific, invisible and subjective experience, which is difficult to describe and for which there are no effective interventions. Fatigue negatively impacts on patients' everyday life, prognosis and quality of life, therefore it is important that patients can manage, monitor and respond to changes in fatigue. To cope with fatigue patients may need or seek advice on self-management strategies. OBJECTIVES: To synthesize the best available evidence on the experiences and management of fatigue in everyday life among adult patients with stable heart failure. INCLUSION CRITERIA TYPES OF PARTICIPANTS: Adults with confirmed and stable heart failure. PHENOMENA OF INTEREST: Studies exploring the experiences and management of fatigue in everyday life among adults with heart failure. TYPES OF STUDIES: Qualitative studies focusing on qualitative data, including, but not limited to, designs within phenomenology, grounded theory or ethnography. SEARCH STRATEGY: A three-step search strategy was used to identify published and unpublished qualitative studies from 1995 to 2014. METHODOLOGICAL QUALITY: Studies that met the inclusion criteria were assessed by two independent reviewers for methodological validity using the standardized critical appraisal tools of the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI). DATA EXTRACTION: Data was extracted from the five included studies using JBI-QARI. DATA SYNTHESIS: Findings were identified and arranged according to the three research questions: patients' experiences of fatigue, impact of fatigue on everyday life and how patients' managed fatigue and its consequences in everyday life. Findings were pooled using JBI-QARI. RESULTS: From the five included studies, 108 findings were derived and subsequently aggregated into 24 categories, which were finally meta-synthesized into five syntheses: "A pervasive and unignorable bodily experience" captured the patients' descriptions of fatigue experiences; "Limited performance of daily living and social activities" and "Loss of self-esteem, identity and intellectual function" aggregated the impact of fatigue on patients' everyday life; "Using protecting and restoring strategies according to the body barometer" and "A dynamic balance between accepting and struggling against fatigue" captured how patients managed fatigue and its consequences. CONCLUSION: Three different types of bodily fatigue challenge patients with heart failure. Decreased physical capacity, unpredictability and fluctuating intensity are dominant features of fatigue experiences, which cause limitations in performing daily and social activities, increased dependency of others, and loss of self-esteem, identity and intellectual function. Patients' management of fatigue and its consequences is an ongoing process involving use of protective and restorative activities to handle the specific bodily fatigue. However it also relates to living constructively with fatigue by striking a balance between adjusting to and struggling against fatigue. IMPLICATIONS FOR PRACTICE: Healthcare providers should be accountable to their patients, recognizing and taking into consideration patients' fatigue experiences and the meaning of fatigue, in order to provide optimal and individual care to their patients. IMPLICATIONS FOR RESEARCH: Further qualitative research is needed to consider cultural factors of importance for managing fatigue in everyday life among patients with heart failure. Furthermore research should explore and test different kinds of physical and mind-body activities on the patients' functional capacity and wellbeing.

The meaningfulness of participating in support groups for informal caregivers of older adults with dementia: a systematic review.

BACKGROUND: Informal caregivers who perform at-home care of older people with dementia might have feelings of a meaningless existence, burden, anxiety, stress and fatigue. Support groups are considered an especially effective and economical way to relieve informal caregivers' stress and burden, although it is unclear if participating in group meetings produces a meaningful outcome for the informal caregiver. OBJECTIVES: To identify the meaningfulness of participating in support groups for informal caregivers of older adults with dementia living in their own home. TYPES OF PARTICIPANTS: Informal caregivers of older adults aged 65 years and over with dementia. The informal caregiver was a family member, and care was performed at home. PHENOMENA OF INTEREST: How the informal caregivers perceived the meaningfulness of participating in support groups. The setting was all locations where support groups for informal caregivers were held and studied. TYPES OF STUDIES: Studies that focused on qualitative data including, but not limited to, designs such as phenomenology, grounded theory, ethnography, action research and feminist research. TYPES OF OUTCOMES: Subjective accounts of the informal caregivers' perceptions of the meaningfulness associated with participating in support groups. Beliefs, benefits, rewards and attitudes related to a caregiver's experiences as a participant in support groups and in the role as caregiver. The perception by informal caregivers of participating in support groups as a way to release stress. SEARCH STRATEGY: The search aimed at finding published and unpublished studies in English, German, Danish, Swedish and Norwegian, and was unrestricted by time. Eleven electronic databases and eleven websites were searched. METHODOLOGICAL QUALITY: Methodological quality of the qualitative papers was assessed independently by two reviewers using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument. DATA EXTRACTION: Qualitative data were extracted from papers included in the review using the standardized data extraction tool from the Joanna Briggs Institute Qualitative Assessment and Review Instrument. DATA SYNTHESIS: Qualitative research findings were synthesized using the Joanna Briggs Institute Qualitative Assessment and Review Instrument. RESULTS: A total of 59 findings from five studies were aggregated into five categories. Three synthesized findings were generated based on the meta-aggregation of the categories: 1) emotional benefits of peer-based support; 2) facing the challenges of caregiving; and 3) embracing the future through virtual configuration of group meetings. CONCLUSIONS: The five studies provided useful and credible findings from caregivers' voices that are not often heard in regard to the meaning of participating in support groups. Peer support is beneficial for caregivers, and it provides a source of positive emotional support and a means of venting negative feeling and gaining help to address issues in the everyday life of caring for older adults with dementia.