To examine which elements of thriving and PERMA may be associated with thriving and intentions to leave both the job and profession among early career nurses.
Retention of early career nurses is a global concern, with up to 60% leaving the profession within 2 years. While organisational factors have been widely examined, psychological constructs such as thriving and well-being are underexplored.
A cross-sectional design.
The study surveyed early career nurses (n = 90, response rate 34.1%) across Australia. Validated instruments assessed thriving, PERMA dimensions, organisational support and intention to leave. Multiple linear and logistic regressions identified key factors associated with thriving and intention to leave the job or profession. Reporting adhered to STROBE guidelines for observational studies.
Thriving was a significant factor associated with engagement (β 0.039, p = 0.031), relationships with colleagues (β 0.167, p = 032), and occupational hardiness (β 0.502, p = 0.001), while accomplishment was a negative factor associated with thriving (β −0.163, p = 0.001). Intention to leave the job was linked to lower levels of thriving (β −1.303, p = 0.048), reduced perceived organisational support (β −0.180, p = 0.048), and higher negative emotions (β 0.747, p = 0.009). Intention to leave the profession was associated with accomplishment (β 0.222, p = 0.048), perceived organisational support (β 0.193, p = 0.001), and years since graduation (β 0.299, p = 0.016).
Thriving was associated with engagement, peer support, and resilience, whereas attrition was associated with poor organisational support and negative affect. Accomplishment is negatively aligned with thriving and may reflect unmet expectations, increasing role strain, or other personal factors not directly related to organisational contexts. Results suggest psychologically supportive environments and PERMA-informed strategies may be important for enhancing early career nurse retention. Supporting nurses to thrive should be a key focus for managers seeking to sustain the nursing workforce.
This study provides actionable insights for creating psychologically supportive environments that may be associated with improved early career nurse retention. By applying the PERMA framework, healthcare leaders may consider implementing targeted strategies, such as fostering engagement, informing the importance of collegial relationships, and promoting resilience, in order to positively inform well-being and achieve lower levels of attrition in clinical settings.
No patient or public contribution.
To identify and report how gender justice is conceptualised and discussed in contemporary health literature in relation to the Triple Planetary Crisis of climate change, pollution and biodiversity loss, with a particular focus on the experiences of women and gender-diverse populations, and the representation of nurses and other healthcare professionals dominated by women.
Scoping review.
Searches were conducted across MEDLINE (Ovid), Scopus, CINHAL, Embase and ProQuest, focusing on studies published from January 1 2000–23 September 2024.
The review was conducted in accordance with the JBI methodology for scoping reviews and reported against the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Data were extracted according to a pre-specified extraction framework, developed a priori, encompassing components of gender justice and intersectionality.
A total of 39 studies were included: 17 (43.6%) qualitative, 17 (43.6%) quantitative and 5 (12.8%) mixed methods. The focus of the studies included gendered experiences of climate change (30.8%), decision-making and governance (20.5%), health and wellbeing (17.9%), women's economic participation (15.4%), cultural and spiritual connections to land (7.7%), and intersectionality and human rights (7.7%). Gender-diverse populations, nurses and other healthcare professions dominated by women were not represented in the literature.
The literature reported that women experienced differentiated exposure to the Triple Planetary Crisis. The underrepresentation of gender diverse people and nurses in recent studies remains a significant barrier to advancing understanding of gender justice. Integrating gender justice into health systems is increasingly important to prevent women from being disproportionately impacted by the Triple Planetary Crisis.
More attention to inclusion of frontline healthcare professionals, including nurses, in governance, policy discussions and leadership roles could strengthen the response to systemic environmental threats.
No patient or public involvement.
To examine participation in workplace and non-workplace emotional well-being programs among nurses.
Cross-sectional survey.
Survey was administered to nurses who participated in the Virtual Schwartz Rounds peer support program retrospectively (sessions November 19, 2020–March 31, 2024; survey administered April 23, 2024–June 22, 2024) or immediately following a session (April 1–December 12, 2024). Of 290 respondents, 55 were excluded due to missing data, yielding an analytic sample of 235 nurses.
Nurses who participated in workplace emotional well-being programs reported greater use of external resources than those who did not. These nurses were more likely to spend time with animals for emotional support, use mindful or physical self-care strategies, and participate in community support, social media, online nursing forums and counselling.
Nurses adopt a multipronged approach to well-being, combining self-care, group and individual supports. Findings underscore maintaining well-being resources, with non-workplace programs complementing workplace initiatives to support the emotional needs of the nursing workforce.
Findings highlight the need for leaders to invest in organizational well-being programs and increase awareness of resources outside the workplace that may support nurses' emotional well-being. These insights can inform development of well-being programs that increase engagement and support patient care.
Nurses experience emotional strain, yet little is known about the resources they use outside workplace programs. This study found that nurses who participate in workplace well-being programs are more likely to engage with additional supports, including self-care practices, peer or community groups and counselling. These findings can inform healthcare organizations and nursing leaders designing well-being initiatives that better support nurses.
The study adheres to Strengthening the Reporting of Observational Studies in Epidemiology guidelines.
This study did not include patient or public involvement in its design, conduct or reporting.
To address the gap in existing postpartum care literature by gaining an in-depth understanding of Australian child and family health nurses' experiences of providing postpartum contraceptive care.
A qualitative exploratory study design, using semi-structured interviews.
Convenience and snowballing sampling methods were employed to recruit child and family health nurses currently practising in Australia. Semi-structured interviews were conducted with 15 nurses in July 2023, and data were analysed using reflexive thematic analysis as outlined by Braun and Clarke. The consolidated criteria for Reporting Qualitative research checklist were used to support the research process.
Despite their frequent contact with postpartum women and acknowledging the importance of postpartum contraceptive care, most participants did not commonly discuss contraception or family planning with mothers and did not feel it was part of their role to do so. Participants cited role ambiguity, limited knowledge of postpartum contraception, lack of clinical practice guidance, time constraints, and competing priorities as contributing to inconsistencies in postpartum contraceptive care provision.
This study highlights critical gaps in the provision of postpartum contraceptive care by child and family health nurses in Australia and underscores the need for systemic changes to promote postpartum contraceptive care as a key component of routine maternal health services.
This study provides actionable evidence for improving the delivery of postpartum contraceptive care, ensuring women are provided with accurate information about their options, and supporting contraceptive uptake to reduce the incidence of short interpregnancy intervals.
Our findings provide practical guidance relevant for healthcare policy and practice, emphasising the need to enhance child and family health nurses training in reproductive health, develop clear clinical practice guidelines, and address systemic barriers such as time constraints to improve the provision of postpartum contraceptive care and support women's reproductive health needs.
Standards for reporting qualitative research (SRQR).
No patient or public contribution.
To investigate the effects of organisational interventions on the incidence, healing and management of pressure injuries in adult patients in acute hospital settings.
Systematic review.
The review included adult patients at risk of or with pre-existing pressure injuries in acute hospital settings, excluding mental health units, emergency departments or operating theatres. Interventions employed in the included studies were categorised using the Cochrane Effective Practice and Organisation of Care taxonomy.
Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Complete and Web of Science Core Collection were searched from 01 January 2012 to 31 December 2023.
Of 8861 records identified, 7 prevention studies met the inclusion criteria. Six studies reported reductions in pressure injury incidence. Included studies employed various combinations of 14 organisational strategies to enhance practices. Educational interventions were utilised in six studies, including educational meetings, materials and outreach visits. Other common strategies included audit and feedback, communities of practice and continuous quality improvement. The interventions targeted patients and clinicians, primarily nurses, with some involving multidisciplinary teams. The focus was on enhancing healthcare practices through systematic approaches and stakeholder engagement.
Organisational strategies targeting both patients and clinicians as part of an intervention bundle may enhance the prevention of pressure injuries in acute hospital settings. Further, high-quality effectiveness–implementation hybrid trials are required to evaluate these strategies.
Organisational factors influence clinicians' ability to implement evidence-based practices. The effectiveness of specific organisational strategies in acute settings is uncertain. Multiple organisational strategies targeting patients and clinicians may improve the implementability of a pressure injury prevention intervention.
This study adhered to PRISMA guidelines.
Neither patients nor the public were directly involved in this study.
This systematic review and meta-analysis evaluated the efficacy of infrared (IR) devices versus the traditional palpation technique for first-attempt success of peripheral intravenous catheter (PIVC) insertion in adults.
Systematic review and meta-analysis of randomised controlled trials (RCTs).
A comprehensive search of PubMed, Embase, Cochrane Library, Scopus and CINAHL was conducted on 28 May 2024 and included articles in English or French published from 1st January 2000 onwards.
Eligible studies included RCTs comparing IR devices with the traditional palpation method for PIVC insertion in adults. The primary outcome was first-attempt success. Secondary outcomes included overall success, number of attempts, cannulation time and patient pain. The risk of bias was assessed using the RoB2 tool, and a random-effects model was applied for meta-analysis.
Five RCTs were included, involving 690 patients and 704 catheters, including 289 PIVCs in patients with Difficult Intravascular Access (DIVA) criteria. First attempt insertion success was similar when using infrared devices (139/331, 42%) and traditional palpation (143/373, 38%) with Risk Ratio (RR) 1.08 (95% CI, 0.69 to 1.70). No significant statistical differences were noted in secondary outcomes: overall insertion success, number of attempts, time to cannulate and patient pain. Clinical and statistical heterogeneity were substantial (primary analysis I 2 = 83%).
Current evidence does not support the systematic use of infrared devices to improve PIVC insertion success, reduce the number of attempts or alleviate patient pain compared with traditional palpation in adults. Further high-quality studies with suitable sample sizes and varied populations are needed to better establish the potential place of infrared devices.
This study highlights the limited benefit of IR devices in routine clinical practice and underscores the need for further research into their use in specialised settings.
No Patient or Public Involvement. This study did not include patient or public involvement in its design, conduct or reporting.
This study examined associations between pregnancy-related fear and stress, occupational exposures, and workplace modifications among pregnant registered nurses in the United States engaged in direct patient care.
A cross-sectional design was used with data collected via an online survey between November 2021 and April 2022. Participants (n = 358) were recruited through social media and listservs. Log-binomial regression models, adjusted for age and parity, estimated prevalence ratios and confidence intervals for associations between occupational exposures and workplace modifications with prevalence of pregnancy-related stress at work and fear of pregnancy or infant complications. Stress, a non-specific physical/psychosocial response to demands, and fear, an emotional response to perceived threat, functioned as distinct constructs.
Emotional and physical environmental hazards were associated with increased prevalence of stress. Emotional and environmental hazards, as well as physical movement, administering antineoplastic medications, infectious disease transmission and scans, were associated with increased prevalence of fear. Each additional occupational exposure increased prevalence of stress by 4% and fear by 12%. Nurses also mitigated risks by implementing workplace modifications. Stress was associated with changing work schedules, while fear was statistically significantly associated with taking extra infection precautions and seeking assistance for CPR.
Findings highlight the need for interventions that address modifiable occupational hazards and improve access to modifications that reduce stress and fear among pregnant nurses.
Strengthening workplace protections could reduce occupational stress, improve nurse retention and enhance patient care quality.
Pregnant nurses face significant occupational hazards, yet limited research has examined their psychosocial effects and mitigation strategies. This study identified key exposures associated with increased stress and fear and showed that workplace modifications varied by stress/fear levels and pregnancy trimester, informing policies to better protect pregnant nurses.
Authors adhered to the STROBE checklist for cross-sectional studies.
This study did not include patient or public involvement in its design, conduct or reporting.
To explore how Early Career Nurses perceive their preparedness for nursing practice, the teaching and learning experiences, and the role of professional experience placements on their professional development.
A qualitative study using a hermeneutic phenomenological approach.
The study involved 25 Early Career Nurses who participated in follow-up interviews 4 years post-graduation in Australia between 2022 and 2024. Data were collected through semi-structured interviews and analysed using Thematic Analysis.
Three key themes emerged: gaps in preparedness, the power of being embedded and too many balls to juggle. Participants indicated a mixed sense of preparedness with significant gaps in clinical skills. They emphasised the critical role of professional experience placements and mentorship to bridge the gap between theoretical knowledge and practical application. Placements and mentorship opportunities were considered essential to develop confidence and competence for effective nursing practice.
The study highlights the necessity for nursing curricula to address significant gaps in clinical skills, particularly in surgical and emergency nursing. By incorporating more simulation-based learning, interprofessional education and robust mentorship programmes, nursing education can better prepare graduates for the realities of clinical practice. These enhancements will help ease the transition from academic training to clinical practice, reducing reality shock and fostering a more confident, competent and resilient nursing workforce.
Nursing education must integrate more simulation-based learning and interprofessional education opportunities, which are crucial for bridging the gap between theoretical knowledge and practical application, ensuring that graduates are adequately prepared for the demands of clinical practice. Additionally, professional experience placements and mentorship should be prioritised to develop the confidence and competence for effective nursing practice.
This study adheres to the Consolidated criteria for reporting qualitative research guidelines.
No Patient or Public Contribution.
To describe nurses' and community-based organization representatives' collaborative strategies for advancing climate justice with communities.
This study used a descriptive, qualitative research design.
Data were gathered from August 2022 to February 2023 with nurses (n = 8) and their community partners (n = 5) in the United States. Community partners were representatives of community-based organizations. Photovoice provided greater context for the thematic analysis of collaborative strategies discussed in semi-structured interviews.
Nurse participants worked in academic or non-profit settings. Nurse-community partnerships addressed corporate pollution and promoted Indigenous sovereignty and multispecies justice. Themes included investigating disease and health events, identifying at-risk populations and connecting them with resources, providing health teaching and counseling, organizing communities and coalitions, and advocating for policy development and enforcement. Self-care supported resilience and well-being in the long struggle for climate justice.
Findings from this study indicated that nurses and their community partners strategize to transition communities away from systems of extraction towards local and regenerative systems that support resilience. Nurses and their community partners recognized the importance of applying an expansive understanding of climate justice, including intersections of pollution and multispecies justice, to promoting planetary health.
Findings from this study support nurse-community collaboration in policy work to advance planetary health. This study also supports nurses' collective action with their community partners to address the effects of white supremacy and colonization. Future research is needed to evaluate the outcomes of nurse-community partnerships for planetary health.
Nurses have called for action on climate justice; however, evidence of effective nursing strategies that advance climate justice is sparse. This study is the first to describe the collaborative strategies nurses implement with community partners to support the transition from injustice to justice in communities most burdened by climate change and industrial pollution.
Healthcare waste production is a significant contributor to carbon emissions, negatively impacting the environment. Ineffective healthcare waste disposal results in greater measures to manage it which is costly to both the environment and healthcare organizations. This study aimed to improve waste management in a tertiary maternity hospital. Specifically, the impact of a midwife-led intervention to improve waste segregation, staff knowledge and attitudes and waste management-related costs was investigated.
A multi-method study including pre- and post-intervention staff waste management knowledge and attitude surveys and waste audits of bins located on the postnatal ward.
The intervention included education sessions, posters and signage by waste bins and monthly newsletters distributed throughout 2021 to raise staff awareness of correct waste segregation processes. Pre- and post-intervention surveys were distributed in early 2021 and early 2022, respectively. The waste audits occurred on three occasions, January, July and December of 2021. The waste audit included total waste in kilograms (kg), waste in kg by segregation and identification of correct and incorrect segregation. Waste audit and quantitative staff survey data were analysed using descriptive statistics and chi square. Qualitative data from the staff surveys were analysed using content analysis.
Knowledge and attitudes to waste management were similar across pre- and post-intervention staff surveys. Knowledge of accurate allocation of specific items to waste streams was variable with errors identified in both the pre- and post-surveys. Waste audit data showed reductions in clinical waste at each measurement, with a 71.2% decrease in clinical waste from baseline to the final audit. Accuracy of waste segregation also improved from the baseline to final audit, resulting in a 48% reduction in waste management costs.
The midwife-led initiative improved waste segregation and achieved the associated waste management cost reduction.
A midwifery-led initiative to address waste production and segregation on a maternity ward had a positive impact on waste segregation practices and associated waste management costs. The existence of change champions along with in-service sessions, posters and newsletters to raise awareness of correct waste segregation resulted in a 71% reduction of incorrect items being placed in clinical waste bins. Challenges such as COVID-19 pressures and workload made it difficult for midwives to engage in waste management education and effective waste segregation.
No patient or public contribution.
Implementing clinician-led waste management interventions across hospital wards while addressing workload issues are likely to have significant cost benefits for organisations and minimise the environmental impacts of healthcare settings.
To examine the direct and indirect predictors of thriving at work and its impact on intention to leave the organisation or profession among early career nurses.
A repeated cross-sectional design.
A sub-study of early career nurses as part of an Australian longitudinal follow up study, commenced in 2018, was conducted. The sub-study asked early career nurses between their second and sixth year after graduating to complete a structured online questionnaire assessing thriving at work and several predictor variables. Data were analysed using Pearson's correlation, multiple linear regression, and path analysis.
Among the 67 participants (response rate of 42.9%), thriving at work was positively correlated with occupational hardiness, social support from colleagues, and wellbeing, while negatively correlated with compassion fatigue. Thriving at work and perceived organisational support were the significant predictors of intention to leave the organisation, while perceived organisational support was the only significant predictor of intention to leave the profession.
The importance of strong collegial relationships, compassion fatigue, and improving wellbeing to enhance thriving at work are highlighted. Fostering an environment where employees can thrive is crucial to reduce the intentions to leave an organisation. Relationships with the managers and quality of care provision also play a crucial role in reducing turnover and leave intentions. Perceived organisational support enhances employee wellbeing, thereby reducing turnover intentions. Future strategies should focus on comprehensive support systems to retain nurses in their organisation and the profession.
Enhancing thriving at work and perceived organisational support can reduce early career nurses' intention to leave their organisation. However, job stressors and interpersonal conflicts also influence professional leave decisions.
This study has adhered to the STROBE guidelines.
No Patient or Public Contribution.
To provide an overview of the challenges that Intensive Care Unit nurses experience during the organ donation process and identify recommended support models or strategies that may assist them when caring for potential organ donors and their families during the organ donation process.
A scoping review was conducted in accordance with JBI methods.
Cochrane Library, MEDLINE (via Ovid), Embase (via OVID), APA PsycINFO (via OVID), Scopus, OVID Emcare, Web of Science and CINAHL (via EBSCO) were searched from the first available start date of the individual database to December 2023.
Eligible studies included peer-reviewed empirical quantitative, qualitative and mixed method studies exploring the challenges experienced by Intensive Care Unit nurses during the organ donation process in adult intensive or critical care settings. Reviewers used Rayyan systematic review software to screen titles, abstracts and full-text articles. Data were gathered using an adapted JBI data extraction tool for scoping reviews.
Twenty-eight papers were included that were published between 1983 and 2023. Most studies (71.4%) used a qualitative approach. Seven key challenges were identified: direct patient care, care for the next of kin, concept of brainstem death, ethical challenges, emotional challenges, challenges around communication and organisational challenges. Several support models were identified including debriefing, training and education, and availability of local or national protocols and guidelines for organ donation.
This scoping review provides an increased understanding of the challenges that Intensive Care Unit nurses experience during the organ donation process. Appropriate support models or strategies may potentially improve nurses' care experience during the organ donation process.
Improved understanding of the nature of challenges during the organ donation process can facilitate the implementation of supportive strategies that may ultimately improve quality of care, consent rates and nurses' and donors' family experiences.
A public representative with family experience of organ donation was involved in developing the protocol and search strategy.
To describe unit leadership and climates for evidence-based practice implementation and test for differences in unit leader and staff nurses' perceptions within maternal–infant units.
A cross-sectional descriptive study.
A convenience sample of maternal–infant unit leaders and nurses (labour, postpartum, neonatal intensive care, paediatrics) from four Midwestern United States hospitals completed a survey including the Implementation Leadership Scale (ILS) and Implementation Climate Scale (ICS). Descriptive statistics described items, subscales and total scores. Independent t-tests with Bonferroni correction tested for differences in perceptions.
A total of 470 nurses and 21 unit leaders responded, representing 17 units. Ratings of unit leadership and climates for implementation were modest at best [ICS: M = 2.17 (nurses), 2.41 (leaders); ILS: M = 2.4 (nurses), 2.98 (leaders)]. Unit leader ratings were statistically significant and higher than nurse ratings.
This study is one of the first to describe unit leadership and climates for implementation in maternal–infant health. To improve outcomes and equity in maternal–infant health, attention on leadership behaviours and unit climates for evidence-based practice implementation is needed.
Nurse leaders are encouraged to evaluate their leadership behaviours and the unit climates they facilitate, and work to improve areas of concern or where staff perceptions differ. Staff nurses should work with their leaders to identify resources and rewards/recognition which support and facilitate EBP implementation.
This study addressed a gap in research examining the social dynamic factors of unit leadership and climate for evidence-based practice implementation in maternal–infant units. Leadership behaviours for implementation and unit climate were rated moderately by both staff and leaders. Unit leaders rated their implementation leadership and climates higher in almost all items. This study is relevant to unit leaders and nurses in maternal–infant units in the United States.
This study adhered to STROBE guidelines.
No patient or public contribution.
To predict nurses' turnover intention using machine learning techniques and identify the most influential psychosocial, organisational and demographic predictors across three countries.
A cross-sectional, multinational survey design.
Data were collected from 1625 nurses in the United States, Türkiye and Malta between June and September 2023 via an online survey. Twenty variables were assessed, including job satisfaction, psychological safety, depression, presenteeism, person-group fit and work engagement. Turnover intention was transformed into a binary variable using unsupervised machine learning (k-means clustering). Six supervised algorithms—logistic regression, random forest, XGBoost, decision tree, support vector machine and artificial neural networks—were employed. Model performance was evaluated using accuracy, precision, recall, F1 score and Area Under the Curve (AUC). Feature importance was examined using logistic regression (coefficients), XGBoost (gain) and random forest (mean decrease accuracy).
Logistic regression achieved the best predictive performance (accuracy = 0.829, f1 = 0.851, AUC = 0.890) followed closely by support vector machine (polynomial kernel) (accuracy = 0.805, f1 0.830, AUC = 0.864) and random forest (accuracy = 0.791, f1 = 0.820, AUC = 0.859). In the feature importance analysis, job satisfaction consistently emerged as the most influential predictor across all models. Other key predictors identified in the logistic regression model included country (USA), work experience (6–10 years), depression and psychological safety. XGBoost and random forest additionally emphasised the roles of work engagement, group-level authenticity and person–group fit. Job-stress-related presenteeism was uniquely significant in XGBoost, while depression ranked among the top predictors in both logistic regression and random forest models.
Machine learning can effectively predict turnover intention using multidimensional predictors. This methodology can support data-driven decision-making in clinical retention strategies.
This study provides a data-driven framework to identify nurses at risk of turnover. By integrating machine learning into workforce planning, healthcare leaders can develop targeted, evidence-based strategies to enhance retention and improve organisational stability.
This study adhered to STROBE reporting guideline.
This study did not include patient or public involvement in its design, conduct or reporting.
To determine the association between patient characteristics, techniques, and technologies with first-time peripheral intravenous catheter insertion in paediatric acute care.
Single-centre, prospective cohort study.
Data on patient, provider, and peripheral intravenous catheter insertion characteristics were collected at a large quaternary paediatric hospital in Queensland, Australia. Inpatients aged 0 to ≤ 18 years requiring a peripheral intravenous catheter or who had one inserted in the last 24 h, were eligible. Proportionate stratified random sampling was used. Generalised linear regression with modified Poisson regression assessed associations between patient variables (e.g., age) and first-time insertion success, along with technique (e.g., inserting clinician) and technology (e.g., ultrasound) variables. Models were adjusted for confounding variables identified through direct acyclic graphs.
199 children required 250 peripheral intravenous catheters (July 2022–September 2023). In the adjusted model, each year of age increase and every 5-kg increase in weight were associated with higher first-time insertion success. Children with a history of prematurity had an increased risk of first-time insertion failure. Vascular access specialists were more likely to succeed on the first attempt, as was ultrasound-guidance when adjusted for difficult intravenous access risk.
We identified techniques (expert clinicians) and technologies (ultrasound guidance) that improve first-time insertion success in paediatric patients.
A multi-faceted approach combining technique (clinician), technology (ultrasound guidance), and standardised policy can improve first-time peripheral intravenous catheter insertion. These strategies minimise patient discomfort, trauma, and emotional distress, enhancing the overall healthcare experience for children and their families.
This study emphasises the need to standardise healthcare policies and training, incorporating clinician expertise and ultrasound guidance to improve first-time insertion success, particularly for high-risk patients.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).
No Patient or Public Contribution.
Australia New Zealand Clinical Trials Registry, ACTRN12622000034730