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1.
Front Psychiatry ; 15: 1393066, 2024.
Article in English | MEDLINE | ID: mdl-38757135

ABSTRACT

Introduction: Depression constitutes one of our largest global health concerns and current treatment strategies lack convincing evidence of effectiveness in youth. We suggest that this is partly due to inherent limitations of the present diagnostic paradigm that may group fundamentally different conditions together without sufficient consideration of etiology, developmental aspects, or context. Alternatives that complement the diagnostic system are available yet understudied. The Power Threat and Meaning Framework (PTMF) is one option, developed for explanatory and practical purposes. While based on scientific evidence, empirical research on the framework itself is still lacking. This qualitative study was performed to explore the experiences of adolescents and young adults with depression from the perspective of the PTMF. Methods: We conducted semi-structured interviews with 11 Swedish individuals aged 15- 22 years, mainly female, currently enrolled in a clinical trial for major depressive disorder. Interviews were transcribed verbatim and analyzed with framework analysis informed by the PTMF. Results: A complex multitude of adversities preceding the onset of depression was described, with a rich variety of effects, interpretations, and reactions. In total, 17 themes were identified in the four dimensions of the PTMF, highlighting the explanatory power of the framework in this context. Not all participants were able to formulate coherent narratives. Discussion: The PTMF provides a framework for understanding the complexities, common themes, and lived experiences of young individuals with depression. This may be essential for the development of new interventions with increased precision and effectiveness in the young.

2.
Issues Ment Health Nurs ; 45(6): 630-638, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38652917

ABSTRACT

Persons with severe mental ill-health die early from preventable physical ill-health. Registered nurses in psychiatric outpatient care play a key role in improving persons' physical health, and it is important to examine how they view their responsibility, their experiences of care, and the obstacles they meet in providing person-centred care. The purpose of this study was to explore registered nurses' experiences of caring for persons with mental ill-health and somatic comorbidity in psychiatric outpatient care, using qualitative content analysis to analyze data from semi-structured interviews. The results show that these nurses monitored the person's right to equal care, embraced the whole of the persons suffering, and dealt with unclear boundaries in care. This highlights the unique role that registered nurses play in psychiatric outpatient care via their ability to interpret symptoms and find ways to adapt care based on persons' needs. Registered nurses consider physical health in all care and provide a link between psychiatric and somatic care. Together with mental health nurses at primary health care centers, they are key in reducing persons' suffering. There is a need for structural and functional changes in line with person-centred care including collaboration both within and outside healthcare organizations.


Subject(s)
Ambulatory Care , Mental Disorders , Psychiatric Nursing , Humans , Mental Disorders/psychology , Mental Disorders/nursing , Female , Adult , Male , Comorbidity , Patient-Centered Care , Attitude of Health Personnel , Middle Aged , Patient Rights , Qualitative Research
3.
Int J Ment Health Nurs ; 32(6): 1681-1690, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37458217

ABSTRACT

Chemical restraints are used in forensic psychiatric inpatient care, however with caution as it can feel like an assault against patients' integrity. When waiting for decisions on treatment without consent, nursing staff are expected to care for patients with severe mental ill-health without the use of medical treatment, often with a feeling of already having tried all other available means. Knowledge about how registered nurses experience such situations is sparse but could contribute to the development of both teamwork and nursing approaches that could mean reduced suffering for patients. The aim of this study was to describe registered nurses' experiences of delayed decisions on treatment without consent in forensic psychiatric inpatient care. Eleven semi-structured interviews were conducted with registered nurses working in forensic psychiatric units in Sweden. Data were analysed through qualitative content analysis. The result showed that experiences of treatment without consent were about striving to protect patients from harm, striving for collaboration during difficult circumstances and striving to do good. This was interpreted as a struggle with unnecessary suffering. For registered nurses to be able to handle such challenging situations and relieve suffering for patients, experience and master-level education in mental health nursing are highlighted. Another aspect that is highlighted is the importance of having consultants familiar with the circumstances at the unit. A method for joint reflection is suggested, to promote an open-minded work culture with a well-functioning decision-making process and ensure that both consultants and nursing staff have support.


Subject(s)
Nurses , Psychiatric Nursing , Humans , Inpatients/psychology , Emotions , Informed Consent , Qualitative Research
4.
Int J Ment Health Nurs ; 32(3): 875-883, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36861747

ABSTRACT

People with severe mental ill-health have lower life expectancies than the rest of the population, partly due to unhealthy lifestyles. Counselling to help these people improve their health can also be complex, and registered nurses are key to its success. The aim of this study was to elucidate registered nurses' experiences of providing health counselling to people living with severe mental ill-health in supported housing. We conducted eight individual semi-structured interviews with registered nurses working in this context and subjected the responses to qualitative content analysis. The results show that registered nurses who counsel people with severe mental ill-health feel dispirited, but they defend their often fruitless endeavours and strive, through health counselling, to help these people meet healthier lifestyle goals. Shifting the focus from traditional health counselling to person-centred care using health-promoting conversations could strengthen registered nurses in their efforts towards improving lifestyles among people living with severe mental ill-health in supported housing. Therefore, to facilitate healthier lifestyles among this population, we recommend that community healthcare support registered nurses working in supported housing by educating them in the use of health-promoting conversations, including teach-back techniques.


Subject(s)
Housing , Nurses , Humans , Qualitative Research , Mental Health , Counseling
5.
Issues Ment Health Nurs ; 43(12): 1145-1154, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36383445

ABSTRACT

While people with mental ill-health report unsatisfying experiences and poor treatment in general emergency departments, nursing staff report a lack of adequate knowledge and training. This study describes nursing staff's experiences caring for people with mental ill-health in general emergency departments. A qualitative descriptive design was used and 14 interviews were subjected to qualitative content analysis. Results show that nursing staff are dealing with uncertainty and competing priorities when caring for people with mental ill-health. Nursing staff must both take and be given the opportunity to maintain and develop confidence and independence and need support in promoting mental health recovery.


Subject(s)
Mental Health , Nursing Staff , Humans , Emergency Service, Hospital , Nursing Staff/psychology , Qualitative Research , Health Knowledge, Attitudes, Practice
6.
Issues Ment Health Nurs ; 43(11): 1056-1063, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36053790

ABSTRACT

Mental health nursing focuses on patients' experiences, accessed through narratives developed in conversations with nursing staff. This study explored nursing staff's experiences of using the nursing intervention Daily Conversations in psychiatric inpatient care. We used a qualitative questionnaire and received 103 responses. Qualitative content analysis of the data resulted in three themes describing both advantages and obstacles with Daily Conversations: Promotes participation, Contributes to confirming relations and Challenges previous structures. To illuminate the significance of confirming acts and make nursing staff more comfortable, the intervention could benefit from being more flexible and allowing in its structure. For the intervention to succeed, nursing staff need training in conversation, thorough preparation, shared reflections on values in mental health nursing, and structures to maintain its implementation and use.


Subject(s)
Mental Health Services , Nursing Staff , Psychiatric Nursing , Humans , Inpatients , Communication
7.
BMC Med Educ ; 22(1): 132, 2022 Feb 28.
Article in English | MEDLINE | ID: mdl-35227281

ABSTRACT

BACKGROUND: Medical students have a higher risk for depression, anxiety, stress-related symptoms, burnout, and suicide, and more rarely seek professional help or treatment than the general population. Appeals are being made to address the mental health and resilience of physicians-to-be. The novel program Training for Awareness, Resilience, and Action (TARA) was originally developed to treat depressed adolescents, targeting specific neuroscientific findings in this population. TARA has shown feasibility and preliminary efficacy in clinically depressed adolescents and corresponding brain-changes in mixed community adolescent samples. The present study investigated the feasibility and acceptability of TARA as a potential indicated prevention program for symptoms of depression, anxiety, stress and burnout in Swedish medical students. METHODS: We conducted a single-arm trial with 23 self-selected students in their early semesters of medical school (mean age 25.38 years, 5 males and 18 females), with or without mental disorders. All participants received TARA. Self-reported symptoms of depression, anxiety, perceived stress and psychological inflexibility were collected before (T0) and after the intervention (T1). Qualitative data on the participants' experiences of TARA were collected in focus-group interviews conducted halfway through the program and upon completion of the program. Individual interviews were also conducted 2 years later. Qualitative content analysis was performed. RESULTS: The mean attendance rate was 61.22% and the dropout rate was 17.40%. The Child Session Rating Scale administered after every session reflected an overall acceptable content, mean total score 34.99 out of 40.00. Trends towards improvement were seen across all outcome measures, including the Hospital Anxiety and Depression Scale Anxiety (t = 1.13, p = 0.29) and Depression (t = 1.71, p = 0.11) subscales, Perceived Stress Scale (t = 0.67, p = 0.51) and Avoidance and Fusion Questionnaire for youth (t = 1.64, p = 0.10). None of the participants deteriorated markedly during the intervention. Qualitative content analysis resulted in a main theme labeled: "An uncommon meeting-ground for personal empowerment", with 4 themes; "Acknowledging unmet needs", "Entering a free zone", "Feeling connected to oneself and others" and "Expanding self-efficacy". CONCLUSION: TARA is feasible and acceptable in a mixed sample of Swedish medical students. The students' reports of entering an uncommon meeting-ground for personal empowerment supports effectiveness studies of TARA in this context.


Subject(s)
Mental Disorders , Students, Medical , Adult , Anxiety/prevention & control , Feasibility Studies , Female , Humans , Male , Mental Health
8.
Issues Ment Health Nurs ; 43(2): 154-163, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34346267

ABSTRACT

BACKGROUND: Self-harm is defined as intentional self-injury without the wish to die. People who self-harm report feeling poorly treated by healthcare professionals, and nurses wish to know how best to respond to and care for them. Increased understanding of the meaning of self-harm can help nurses collaborate with young people who self-harm to achieve positive healthcare outcomes for them. AIM: This review aimed to synthesise qualitative research on young peoples' experiences of living with self-harm. METHOD: A literature search in CINAHL, PubMed, and PsycINFO resulted in the inclusion of 10 qualitative articles that were subjected to metasynthesis. RESULTS: The results show that young people's experiences of living with self-harm are multifaceted and felt to be a necessary pain. They used self-harm to make life manageable, reporting it provided relief, security, and a way to control overwhelming feelings. They suffered from feeling addicted to self-harm and from shame, guilt, and self-punishment. They felt alienated, lonely, and judged by people around them, from whom they tried to hide their real feelings. Instead of words, they used their wounds and scars as a cry for help. CONCLUSION: Young people who harm themselves view self-harm as a necessary pain; they suffer, but rarely get the help they need. Further research is necessary to learn how to offer these people the help they need.


Subject(s)
Self-Injurious Behavior , Adolescent , Guilt , Humans , Pain , Qualitative Research , Self-Injurious Behavior/therapy , Shame
9.
Int J Qual Stud Health Well-being ; 16(1): 1952523, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34254902

ABSTRACT

BACKGROUND: Nurses often work alone in complex environments with ambiguous responsibilities and need ensured access to supervision.Online supervision has become common and has potential to support supervision in rural areas. AIM: To explore the experiences of registered nurses (RNs) learning online to be a supervisor in professional supervision in nursing. DESIGN: A longitudinal qualitative design was used. METHODS: A total of six focus group discussions, with 15 RNs divided in two groups, were conducted before, during, and after the training. Data underwent qualitative content analysis. RESULTS: Results showed that the participants experienced learning to be a supervisor online as a personal and professional journey, and learning online was an advantage rather than a disadvantage. Initially, they focused on themselves, then on themselves within the group, and finally on themselves and the group. Both the group and the internet environment were described as safe places. Online tutoring needs to include the creation of a social presence within the group.


Subject(s)
Clinical Competence , Learning , Focus Groups , Humans
10.
Int J Ment Health Nurs ; 30(6): 1539-1549, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34196099

ABSTRACT

People with mental ill health attend general emergency care more often than others for physical and psychiatric care needs. Staff in general emergency care report they lack knowledge and strategies to meet with and care for people with mental ill health. This study aimed to describe how people with mental ill health experience encounters with staff in general emergency care. We conducted individual semi-structured interviews with 11 people with mental ill health about their experiences in general emergency care and subjected the interview data to qualitative content analysis. Our results show the importance to people with mental ill health of being acknowledged as capable persons, and how this relates to their experiences of being recognized, ignored, or dismissed by staff in general emergency care. Even small, ordinary aspects of staff/patient interactions can have major impacts on a person's recovery and well-being. The study is reported according to the consolidated criteria for reporting qualitative research (COREQ) guidelines.


Subject(s)
Emergency Medical Services , Mental Health , Emergencies , Emergency Service, Hospital , Humans , Qualitative Research
11.
Issues Ment Health Nurs ; 42(12): 1114-1122, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34142934

ABSTRACT

The environment in psychiatric inpatient care is key to patient recovery and staff job satisfaction. In this qualitative study of patient and staff experiences of a new spatial design in psychiatric inpatient care, we analysed data from 11 semi-structured interviews with patients and five focus group discussions with staff using qualitative content analysis. The new design contributed to feelings of safety and recovery, but patients and staff also reported some frustration and added stress. The results lead us to conclude that while the new spatial design improves some conditions for recovery and job satisfaction, the design itself is simply not enough. Changes in care environments require that both patients and staff be informed and involved in the renovation to ensure that patients feel respected and staff feel confident in using the new environment before and during treatment and follow-ups.


Subject(s)
Inpatients , Mental Health Services , Focus Groups , Humans , Job Satisfaction , Qualitative Research
12.
Lakartidningen ; 1182021 03 17.
Article in Swedish | MEDLINE | ID: mdl-33754329

ABSTRACT

Psychiatric care has changed dramatically from inpatient to outpatient care in the last decades. While a lot of resources have been spent on developing outpatient care, less interest has been invested in inpatient care, which has repeatedly been critisezed for being dominated by control, lack of collaboration between staff and patient and boredom. We suggest that there are three main functions of the psychiatric ward: the asylum function, the intensive care and the observational/diagnostic function. We also present some recent projects aimed at improving the quality of care and we argue for more involvment of the psychiatrists in the internal life and functioning of the psychiatric ward.


Subject(s)
Inpatients , Mental Health Services , Hospitalization , Humans , Psychiatric Department, Hospital
13.
Issues Ment Health Nurs ; 42(8): 776-783, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33443452

ABSTRACT

Suicide risk assessment is a complex task for nurses working in psychiatric inpatient care. This study explored psychiatric inpatient nurses' experiences of assessing suicide risk. A qualitative design was used, and 10 interviews were subjected to qualitative content analysis. Nurses described suicide risk assessments as requiring them to create caring alliances and to take responsibility. Collaborating with colleagues was another part of nurses' experiences, as was feeling abandoned. To make the assessment safely, nurses need a combination of caring alliances, support from colleagues, clear guidelines, training and time for collegial reflection to create a supportive working climate.


Subject(s)
Nurses , Suicide Prevention , Humans , Inpatients , Qualitative Research , Violence
14.
Issues Ment Health Nurs ; 42(6): 564-572, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32937081

ABSTRACT

The aim of this study was to describe nursing staff's experiences of good nursing practice in psychiatric in-patient care for patients with self-harming behavior. The participants were nine nurses and eight nursing assistants working in two in-patient wards in general psychiatry. Four focus group discussions were held and subjected to qualitative content analysis. The findings showed that good nursing practice balanced a person-centred approach with a common staff approach, allowing people who self-harm and staff to share responsibility for structuring everyday life, keeping to the plan, communicating decisions, and finding individual opportunities for relief. Reflective discussions among the staff concerning prejudice, emotional stress, lack of resources, and shortcomings in care planning could also prevent a stigmatizing culture and organizational deficiencies, which would be beneficial for both the people who self-harm and the staff.


Subject(s)
Nurses , Nursing Staff , Self-Injurious Behavior , Attitude of Health Personnel , Focus Groups , Humans
15.
Issues Ment Health Nurs ; 42(6): 549-554, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32975473

ABSTRACT

Interactions with staff are important aspects in patients' experiences of psychiatric inpatient care (PIC). This study aimed to evaluate patients' satisfaction with their interactions with PIC staff and whether sociodemographic factors, depression and anxiety symptoms were associated with their perceptions of these interactions. In this cross-sectional study, we collected data from 84 patients receiving inpatient care in three psychiatric settings in Sweden. The patients' perceptions of interactions with staff and self-reported degrees of depression and anxiety were evaluated through questionnaires. Overall, patients were satisfied with the patient-staff interaction. However, significantly higher scores were related to staffs' practical competence than to their compassion. Older patients reported significantly more satisfaction than younger patients with their most recent meeting with staff. Tailored nursing interventions may improve staff's compassionate capacity. Further research in larger samples is needed to improve our understanding of the factors associated with how patients perceive their interactions with staff.


Subject(s)
Empathy , Patient Satisfaction , Cross-Sectional Studies , Humans , Inpatients , Surveys and Questionnaires , Sweden
16.
Int J Ment Health Nurs ; 29(6): 1192-1201, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32618398

ABSTRACT

A lack of meaningful activities for people with mental ill health admitted to psychiatric inpatient care has been related to feelings of boredom and 'doing nothing' and is not in line with recovery-oriented care. Staff in psychiatric inpatient care report having limited time, ambiguous responsibilities, and insufficient support that counteracts their ideals of good nursing care and puts them at risk for high levels of stress and stress of conscience. Research highlights a need for interactions between patients and staff, but few nursing interventions with such a focus are described in the literature. This qualitative study aimed to illuminate staff experiences of introducing and participating in the nursing intervention Time Together, via qualitative content analysis of 17 individual semi-structured interviews with nursing staff in psychiatric inpatient care. The results show that these staff members experienced Time Together as an arena for mental health nursing. They prepared for the introduction of the intervention by laying a framework for success. Although the actual implementation led to them feeling burdened, they found that Time Together fostered relationships between patients and staff. For successful implementation, mental health nurses need to advocate the intervention. As Time Together constitutes an arena for mental health nursing, play and conversations based on reciprocity and equality can contribute to patients' recovery.


Subject(s)
Mental Disorders , Mental Health Services , Psychiatric Nursing , Humans , Inpatients , Mental Disorders/therapy , Patient Care , Qualitative Research
17.
Int J Ment Health Nurs ; 28(1): 7-21, 2019 Feb.
Article in English | MEDLINE | ID: mdl-29975446

ABSTRACT

Historically, people with mental ill-health have been isolated from society. Although mental health care has moved from closed to more open forms of care, in many societies care is still provided in locked wards, and people with mental ill-health are sometimes secluded from their fellow patients, families, friends, and visitors. The aim of this study was to illuminate patients' experiences of isolation in psychiatric inpatient care. A systematic review of qualitative research was conducted, and the key findings were subjected to meta-ethnographic synthesis. The findings were twofold: 'being admitted to prison' and 'having access to shelter'. The experience of isolated care as prison-like symbolizes patients' longing for freedom and feeling restricted and limited by rules, stripped of rights, abandoned, controlled, powerless, and unsupported. In contrast, the experience of isolation as shelter symbolizes safety and the opportunity to regain control over one's own situation. A stigmatizing public view holds that people with mental ill-health are dangerous and unpredictable and, therefore, unsafe to themselves and others. Being placed in isolation because these fears contribute to self-stigma among patients. Promoting a sheltered experience in which isolation is used with respect for patients and the reasons are made explicit may encourage recovery. A shift in emphasis in ward culture from observation to engagement is needed to reduce blame, shift patient experiences from prison to shelter, and to support autonomy as a therapeutic intervention.


Subject(s)
Inpatients/psychology , Patient Isolation/psychology , Adult , Anthropology, Cultural , Hospitals, Psychiatric , Humans , Mental Disorders/psychology , Mental Disorders/therapy , Psychiatric Department, Hospital
18.
Int J Ment Health Nurs ; 28(2): 551-559, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30501013

ABSTRACT

This qualitative study aimed to illuminate patients' experiences of taking part in the nursing intervention Time Together. The data were drawn from 11 individual semi-structured interviews with patients and analysed with qualitative content analysis using an inductive approach. The results show that patients taking part in Time Together felt confirmed and participated on equal terms; thus, they experienced being seen as humans among other humans. Time Together offered patients a break, and they felt strengthened, which contributed to their hopes for recovery. Furthermore, when Time Together was absent patients felt disconfirmed, which fostered feelings of distance from staff. The results support the effectiveness of the intervention, indicating that Time Together may be a tool to facilitate patients' personal recovery. However, the success of the intervention depends on staff compliance with the predetermined structure of the intervention in combination with engagement.


Subject(s)
Mental Disorders/nursing , Nurse-Patient Relations , Psychiatric Nursing/methods , Adult , Female , Humans , Inpatients/psychology , Male , Mental Disorders/therapy , Psychiatric Department, Hospital
19.
Int J Ment Health Nurs ; 27(6): 1698-1708, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29691976

ABSTRACT

The facilitation of quality time between patients and staff in psychiatric inpatient care is useful to promote recovery and reduce stress experienced by staff. However, interventions are reported to be complex to implement and are poorly described in the literature. This multisite study aimed to evaluate the feasibility and effects of the nursing intervention Time Together, using mixed methods. Data consisted of notes from participant observations and logs to evaluate feasibility, and questionnaires to evaluate effects. The primary outcome for patients was quality of interactions, and for staff, it was perceived stress. The secondary outcome for patients was anxiety and depression symptom levels, and for staff, it was stress of conscience. Data were analysed using visual analysis, percentage of nonoverlapping data, and qualitative content analysis. The results showed that Time Together was a feasible intervention, but measurements showed no effects on the two patient outcomes: quality of interactions and anxiety and depressive symptoms and, questionable effects on perceived stress and stress of conscience among staff. Shared responsibility, a friendly approach, and a predictable structure enabled Time Together, while a distant approach and an unpredictable structure hindered the intervention. In conclusion, the intervention proved to be feasible with potential to enable quality interactions between patients and staff using the enabling factors as supportive components. It also had some effects on perceived stress and stress of conscience among staff. Further evaluation is needed to build on the evidence for the intervention.


Subject(s)
Mental Disorders/nursing , Psychiatric Nursing/methods , Adolescent , Adult , Aged , Anxiety/nursing , Anxiety/therapy , Depression/nursing , Depression/therapy , Feasibility Studies , Female , Humans , Male , Mental Disorders/therapy , Middle Aged , Nurse-Patient Relations , Surveys and Questionnaires , Young Adult
20.
Pilot Feasibility Stud ; 4: 191, 2018.
Article in English | MEDLINE | ID: mdl-30607254

ABSTRACT

BACKGROUND: Research shows that worn-out physical environments are obstacles to psychiatric inpatient care. Patients want better relationships with staff and things to do; staff want an environment that offers hope, a calm atmosphere, and joint activities. A county council in northern Sweden and Philips Healthcare partnered to create solutions to the environmental challenges of psychiatric inpatient care. One ward at a county psychiatric clinic was selected for a pilot project to test solutions that could improve the care environment for patients, staff, and relatives. The aim of the overall project is to evaluate the effects of a newly designed psychiatric inpatient ward on patients and staff in terms of quality of care and stress. In this study, we focus on the feasibility through testing questionnaires and exploring barriers to recruiting staff and patients. METHODS: This study had a single-system experimental design, comparing a psychiatric unit pre- and post-implementation of the novel spatial design, using repeated measures with the same questionnaires twice a week during baseline and intervention phases. Primary outcomes were quality interactions (patients) and perceived stress (staff). Secondary outcomes were levels of anxiety and depression (patients), and stress of conscience (staff). A process evaluation was aimed to describe contextual factors and participant experiences of the new design. Data was collected using questionnaires and semi-structured individual interviews with patients and focus group discussions with staff. Both visual and statistical methods were used to analyse the quantitative data and content analysis for the qualitative data. DISCUSSION: The findings will contribute insights into whether and how a new spatial design might contribute to quality interactions and reduced stress. This is relevant both nationally and internationally, as similar interventions are needed but sparse. The findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03140618, registered 4 May 2017.

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