Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Work-related factors predict changes in physical activity among nurses participating in a web-based worksite intervention: A randomized controlled trial.

BACKGROUND: Despite the numerous benefits associated with physical activity (PA), most nurses are not active enough and few interventions have been developed to promote PA among nurses. A secondary analysis of raw data from a single-centre, three-arm parallel-group randomized controlled trial was conducted to assess whether work-related characteristics and general mood states predict changes in total weekly moderate-to-vigorous intensity PA (MVPA) and average daily step-count among nurses participating in a 6-week web-based worksite intervention. METHODS: Seventy nurses (meanage: 46.1 ± 11.2 years) were randomized to an individual-, friend-, or team-based PA challenge. Participants completed questionnaires pre- and post-intervention assessing work-related characteristics (i.e., shift schedule and length, number of hours worked per week, work role) and general mood states (i.e., tension, depression, anger, confusion, fatigue, vigour). Participants received a PA monitor to wear before and during the 6-week PA challenge, which was used to assess total weekly MVPA minutes and average daily step-count. Data were analyzed descriptively and using multilevel modeling for repeated measures. RESULTS: Change in total weekly MVPA minutes, but not change in average daily step-count, was predicted by shift schedule (rotating vs. fixed) by time (estimate = - 17.43, SE = 6.18, p = .006), and work role (clinical-only vs. other) by time (estimate = 18.98, SE = 6.51, p = .005). General mood states did not predict change in MVPA or change in average daily step-count. CONCLUSIONS: Given that nurses who work rotating shifts and perform clinical work showed smaller improvements in MVPA, it may be necessary to consider work-related factors/barriers (e.g., time constraints, fatigue) and collaborate with nurses when designing and implementing MVPA interventions in the workplace. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04524572 . August 24, 2020. This trial was registered retrospectively. This study adheres to the CONSORT 2010 statement guidelines.

Process evaluation of a complex workplace intervention to prevent musculoskeletal pain in nursing staff: results from INTEVAL_Spain.

BACKGROUND: INTEVAL_Spain was a complex workplace intervention to prevent and manage musculoskeletal pain among nursing staff. Process evaluations can be especially useful for complex and multifaceted interventions through identifying the success or failure factors of an intervention to improve the intervention implementation. OBJECTIVES: This study performed a process evaluation of INTEVAL_Spain and aimed to examine whether the intervention was conducted according to the protocol, to investigate the fulfilment of expectations and the satisfaction of workers. METHODS: The intervention was a two-armed cluster randomized controlled trial and lasted 1 year. The process evaluation included quantitative and qualitative methods. Quantitative methods were used to address the indicators of Steckler and Linnan's framework. Data on recruitment was collected through a baseline questionnaire for the intervention and the control group. Reach and dose received were collected through participation sheets, dose delivered and fidelity through internal registries, and fulfilment of expectations and satisfaction were collected with two questions at 12-months follow-up. Qualitative methods were used for a content analysis of discussion groups at the end of the intervention led by an external moderator to explore satisfaction and recommendations. The general communication and activities were discussed, and final recommendations were agreed on. Data were synthesized and results were reported thematically. RESULTS: The study was performed in two Spanish hospitals during 2016-2017 and 257 workers participated. Recruitment was 62 and 51% for the intervention and the control group, respectively. The reach of the activities ranged from 96% for participatory ergonomics to 5% for healthy diet. The number of sessions offered ranged from 60 sessions for Nordic walking to one session for healthy diet. Fidelity of workers ranged from 100% for healthy diet and 79% for participatory ergonomics, to 42 and 39% for Nordic walking and case management, respectively. Lowest fidelity of providers was 75% for case management and 82% for Nordic walking. Fulfilment of expectations and satisfaction ranged from 6.6/10 and 7.6/10, respectively, for case management to 10/10 together for the healthy diet session. Discussion groups revealed several limitations for most of the activities, mainly focused on a lack of communication between the Champion (coordinator) and the workers. CONCLUSIONS: This process evaluation showed that the implementation of INTEVAL_Spain was predominantly carried out as intended. Process indicators differed depending on the activity. Several recommendations to improve the intervention implementation process are proposed. TRIAL REGISTRATION: ISRCTN15780649 .

Effectiveness of an educational program for mid-level Japanese public health nurses to improve program planning competencies: A preliminary randomized control trial.

OBJECTIVE: To evaluate the effectiveness of an education program for mid-level Japanese public health nurses (PHNs) to improve their competencies in program planning, which will fulfill community health needs. DESIGN: Randomized control trial. SAMPLE: During 2017, 103 PHNs with 5-20 years of PHN work experience in Japan were enrolled and randomly allocated to the intervention (n = 51) or control group (n = 52). MEASUREMENTS: The primary outcome measured competency in program planning based on Competency Measurement of Creativity for PHNs (CMC), knowledge, and skills regarding program planning. INTERVENTION: Six web-based learning modules followed by two face-to-face group sessions. RESULTS: The PHN participants averaged about 12 years of experience. In the intervention group, 25 PHNs completed all modules (49.0%). Post intervention, there were no statistically significant differences among any between-group CMC scores. However, the intervention group's CMC 3 score was significantly higher than that of the control group of ≥12 years of experience. Total knowledge and skill scores also improved significantly in the intervention group compared with the control group. CONCLUSIONS: The results suggest that PHNs with ≥12 years of experience are a suitable target of this educational program, and should play a key role in program planning.

Educational program for middle-level public health nurses to develop new health services regarding community health needs: protocol for a randomized controlled trial.

BACKGROUND: Developing health services is a key strategy for improving the community health provided by public health nurses. However, an effective educational program for improving their skills in planning such services has not been developed. To describe our program and its evaluation protocol for the education of middle-level public health nurses to improve their skills in developing new health services to fulfil community health needs in Japan. METHODS: In this randomized control trial, eligible participants in Japan will be randomly allocated to an intervention group and a control wait-list group. We will provide 8 modules of web-based learning for public health nurses from July to October 2018. To ensure fairness of educational opportunity, the wait-list group will participate in the same program as the intervention group after collection of follow-up data of the intervention group. The primary outcomes will be evaluated using the scale of competency measurement of creativity for public health nurses at baseline, immediately after the intervention. Secondary outcomes will be knowledge and performance regarding program development of public health nurses. DISCUSSION: This study will enable the analysis of the effects of the educational program on public health nurses for improving their competency to develop new health services for fulfilling community health needs and enriching health care systems. TRIAL REGISTRATION: We registered our study protocol to the University hospital Medical Information Network- Clinical Trials Registry approved by International Committee of Medical Journal Editors (No. UMIN000032176, April, 2018).

Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway.

BACKGROUND: It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. METHODS/DESIGN: The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption. DISCUSSION: The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. TRIAL REGISTRATION: ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

A self-liberation intervention using a pedometer to encourage physical activity among sedentary nursing staff: A randomized controlled trial.

Objective: Nurses make up the majority of the workforce in any healthcare system. Physical inactivity due to heavy workloads has been widely reported among nurses. This study aimed to examine whether a self-liberation intervention could help nurses increase their physical activity levels that would result in other health benefits. Methods: A two-armed randomized controlled trial was implemented among 40 nurses (20 per arm). The control arm received information about the benefits of physical activity, but with no intervention. The intervention arm received the same information and were given pedometers for 12 weeks to record their daily steps while also receiving weekly reminders. Measurements were taken for anthropometric data, self-reported physical activity, exercise stage-of-change, exercise self-efficacy, and pedometer steps (intervention arm only). All statistical analyses were two-sided, with p ⩽ 0.05. Results: The respondents' mean age was 47.9 ± 7.02 years with 90% being female. After the intervention, the intervention arm achieved a higher self-efficacy score (4.60 ± 1.75 to 5.63 ± 2.48) while a decline was observed in the control arm (5.02 ± 2.08 to 4.50 ± 1.90). At baseline, 16.7% (n = 3) of the control arm and 27.8% (n = 5) of the intervention arm were classified as moderately physically active (McNemar's test = 1.20, p = 0.549). After 12 weeks, this proportion increased to 27.7% (n = 5) in the control arm and 50.0% (n = 9) in the intervention arm (McNemar's test = 5.00, p = 0.172). For the intervention arm, mean daily step counts rose from 8889 ± 579.84 at week 1 to 9930 ± 986.52 at week 12 and reached the level of statistical significance (p < 0.01). Waist circumference of the intervention arm decreased significantly more than that of the control group (p < 0.01). Conclusion: The self-liberation intervention using a pedometer had positive effects on assisting sedentary nursing staff to progress through the stages of health behavior change and on their exercise self-efficacy, which could further help increase their exercise adherence and overall physical and mental wellbeing.

Nurse-delivered acupressure on early postoperative gastrointestinal function among patients undergoing colorectal cancer surgery.

Objective: Postoperative gastrointestinal dysfunction occurred up to 25% of patients who undergo colorectal cancer surgery, which could cause severe complications and increase economic burden. This study aims to evaluate the effectiveness of nurse-delivered acupressure on early postoperative gastrointestinal function among patients undergoing colorectal cancer surgery. Methods: A total of 112 adult patients (≥ 18 years) scheduled to receive colorectal cancer surgery were randomized into two groups. Acupressure was practiced at ST36 for five days after operation, while the control group used gently rubbing skin. Primary outcomes were the time to first passage of flatus and defecation, while the secondary outcomes were the degree of abdominal distention and bowel motility. The Student's t-test and Mann-Whitney U test or Chi-square test and regression analyses were used, while for repeated measures of outcomes, area under the curve (AUC) was compared between groups and subgroups. Results: After adjusting for potential confounding variables, acupressure significantly shortened the time to have first flatus passage by 11.08 â€‹h (95%CI: -19.36 to -2.81; P â€‹< â€‹0.01). The first passage time of defecation (mean, 77.00 â€‹± â€‹36.27 â€‹h vs. 80.08 â€‹± â€‹28.88 â€‹h), abdominal distention (AUC, 5.68 â€‹± â€‹5.24 vs. 5.92 â€‹± â€‹4.03), and bowel motility (AUC, 12.09 â€‹± â€‹4.70 vs. 11.51 â€‹± â€‹3.00) in the intervention group had some improvement although the differences were not statistically significant (P â€‹> â€‹0.05). Conclusions: This study indicated that acupressure done by trained nurses could be an effective and feasible solution to promote early gastrointestinal function recovery among patients undergoing colorectal cancer surgery. Trial registration: Chinese Clinical Trial Registry (ChiCTR-IOR-17012460).

Effectiveness of an educational intervention about inhalation technique in healthcare professionals in primary care: a cluster randomized trial.

Background: Incorrect inhalation technique (IT) is an important issue for chronic obstructive pulmonary disease (COPD) patients and healthcare professionals. Studies in which counseling is carried out with healthcare professionals beforehand so that they can properly educate their patients are required. The objective of the present trial is to assess the improvement in the performance of the IT in subjects with COPD and prescribed inhaled therapy after the implementation of an educational intervention conducted by their general practitioners. Methods: A cluster randomized clinical trial was conducted. A total of 286 COPD patients received scheduled inhalation therapy from 27 general practices in seven primary care centers. A teach-back educational intervention was implemented for both healthcare professionals and patients. The primary outcome of this study was the performance of the correct inhalation technique. It is considered a good technique if all steps in the inhalation data sheet are correctly performed. The secondary outcomes were assessed using forced spirometry, the basal dyspnea index, the Medical Research Council dyspnea scale, St George's Respiratory Questionnaire (SGRQ), and EuroQoL5D-5L for health-related quality of life. A one-year follow-up was conducted using an intention-to-treat analysis. Results: After the intervention, incorrect IT was observed in 92% of professionals and patients, with rates reaching 50% and 69.2%, respectively. The effectiveness in patients was significant, with a number needed to treat of 2.14 (95% CI 1.79-2.66). Factors related to correct IT in patients included the type of intervention, length of intervention (>25 min), good pulmonary function, age (youngest <=65, oldest >83), and less limitation of activity due to dyspnea. There was no relation with the cluster. Conclusion: This study shows the effectiveness of direct inhaler technique training provided by a trained professional on an appropriate timescale (for example, a specific consultation for medication reviews), aiming to help subjects improve their performance using the teach-back method. This could be an encouraging intervention to improve medication adherence and health promotion in people with COPD. Clinical Trial Registration: clinicaltrials.gov, identifier ISRCTN93725230.

Protocol of Randomized Controlled Trial to Evaluate the Effectiveness of Nurse-Led Intervention on Weight Reduction among Adults with Obesity in Urban Areas of Puducherry.

Background: A large percentage of non-communicable diseases are preventable through the reduction of behavioral risk factors which is due to physical inactivity and unhealthy diet. Reducing the burden of obesity is likely to make a substantial impact on mitigating the mortality and morbidity due to non-communicable diseases. This study aims to evaluate the effectiveness of a nurse-led intervention on weight reduction among urban adults. Methods: This trial is a two-arm parallel group randomized controlled trial comparing the intervention arm-nurse-led intervention (NLI, n = 219) with the control arm-general care (GC, n = 219). Participants randomized to the NLI group will receive the interventional package for 12 months which includes health education and motivational strategies during follow-up. Baseline, 6-month and 12-month follow-ups will be conducted to assess primary and secondary outcomes for both arms using the WHO Steps questionnaire. The analysis will use an intention-to-treat approach to examine the change in behavioral and physical and biochemical parameters. Conclusion: The nurse-led intervention aims to provide an evidence-based acceptable and flexible support strategy for weight reduction in obese adults. This will impart healthy life skills to adults and also improve their health status and enable an adult to take charge of their health and this will ultimately prevent or delay non-communicable diseases. Trial Registration: Clinical Trials Registry India, CTRI/2021/12/038785. Registered prospectively with CTRI on 21/12/2021.

Effects of a Community Health Worker-Led Health Literacy Intervention on Lifestyle Modification Among Patients With Hypertension and Diabetes in the City of Harare, Zimbabwe: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol. OBJECTIVE: This study aims to evaluate the effects of a community health worker (CHW)-led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence. METHODS: This is a 6-month-long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle. RESULTS: Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants' recruitment, and the final data collection will be completed by January 31, 2024. CONCLUSIONS: There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47512.

Psychological stress self-help interventions for healthcare workers in the context of COVID-19 in China: A randomized controlled trial protocol.

Background: Public health emergencies may lead to severe psychological stress, especially for healthcare workers, including frontline healthcare workers and public health workers. However, few stress management interventions have been implemented for healthcare workers even though they require more comprehensive interventions than the general public. Self-Help Plus (SH+) is a novel psychological self-help intervention developed by the World Health Organization. It is accessible, scalable, and cost-effective and has the potential to be quickly applied to help people cope with stress and adversity. The major objective of this study is to evaluate the effectiveness of SH+ interventions on the alleviation of stress levels and mental health problems among healthcare workers. Methods: A randomized controlled trial of SH+ will be conducted to investigate the stress level and mental health status of Chinese healthcare workers and control subjects in Guangzhou. Assessments will be performed before (baseline), at the end of (1 month), and 2 months after (3 months) the intervention. After completing the baseline screening questionnaire, eligible participants will be randomly assigned to one of the two groups in a 1:1 ratio by block randomization. During the 1-month intervention period, the intervention group will receive the SH+ intervention and the control group will receive information about mental health promotion. The intervention will be delivered by the research assistant via social media platforms. The primary outcome is the level of stress, which will be measured by a 10-item Perceived Stress Scale. Secondary outcomes including mental health symptoms will also be collected. Discussion: Given the potential for multiple COVID-19 waves and other infectious disease pandemics in the future, we expect that SH+ will be an effective stress management intervention for healthcare workers. The findings from this study will facilitate the application of SH+, and the trial is expected to be extended to a larger population in the future.

Feasibility of an educational program for public health nurses to promote local healthcare planning: protocol for a pilot randomized controlled trial.

BACKGROUND: Promoting of local healthcare planning is crucial for assisting public health nurses in improving community health inequities. However, there is no effective educational program for developing relevant skills and knowledge among these nurses. Therefore, this study aims to assess the feasibility of a newly developed web-based self-learning program to promote the involvement of public health nurses in the local healthcare planning process. METHODS: A pilot randomized control trial randomly allocated eligible public health nurses to intervention and control wait-list groups [1:1]. The former will be exposed to six web-based learning modules from July to October 2021. After collecting post-test data, the wait-list group will be exposed to the same modules to ensure learning equity. The primary outcome will be evaluated by implementing a validated and standardized scale designed to measure public health policy competencies at the baseline and post-intervention, while secondary outcome will be measured on an action scale to demonstrate the necessity of healthcare activities. The third outcome will be the knowledge and skills related to local healthcare planning by public health nurses. The participants will provide feedback through free descriptions on the trial feasibility and a web-based self-learning program to identify improvement points for continual refinement. DISCUSSION: The results will provide suggestions in preparation for a future definitive randomized controlled trial. This will provide preliminary data for an intervention aimed at improving relevant competencies among public health nurses who are tasked with resolving health inequities in their respective communities through local health planning. TRIAL REGISTRATION: The protocol for this study was registered with the University Hospital Medical Information Network Clinical Trials Registry and approved by the International Committee of Medical Journal Editors (No. UMIN000043628 , March 23, 2021).

A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial.

BACKGROUND: Mental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers-the Thrive program-has been newly developed to promote habits and activities that contribute to brain health and overall mental well-being. OBJECTIVE: This paper describes the protocol for a randomized controlled trial whose objective is to evaluate the Thrive program in comparison with an active control condition to measure whether the program is effective at increasing well-being and decreasing symptoms of psychological distress in health care workers at a designated Australian hospital. METHODS: The trial will comprise two groups (intervention vs active control) and 4 measurement occasions over a 12-week period. A survey will be administered in each of weeks 0, 4, 8, and 12, and the well-being program will be delivered in weeks 1-7 (via web-based video presentations or digital pamphlets). Each of the 4 surveys will comprise a range of questionnaires to measure well-being, psychological distress, and other key variables. The planned analyses will estimate group-by-time interaction effects to test the hypothesis that mental health will increase over time in the intervention condition relative to the active control condition. RESULTS: The Thrive program was delivered to a small number of wards at the hospital between February 2021 and July 2021, and it will be delivered to the remaining wards from October 2021 to December 2021. A power calculation has recommended a sample size of at least 200 participants in total. A linear mixed model will be used to estimate the interaction effects. CONCLUSIONS: This trial seeks to evaluate a new web-based well-being program for health care workers at a major public hospital. It will contribute to the growing body of research on mental well-being and ways to promote it. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000027819; https://tinyurl.com/58wwjut9. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34005.

Testing the Effectiveness of Cognitive Behavioral Therapy in Relieving Nurses' Ageism Toward Older Adults: A Randomized Controlled Trial.

BACKGROUND: Although cognitive-behavioral therapy (CBT) techniques are well known for targeting psychological distresses, to date, no study has investigated their effectiveness in relieving death anxiety and ageism among nurses. METHODS: A parallel randomized controlled trial was conducted according to the CONSORT guidelines during October 2019 at the university hospital. A total of 110 nurses were selected through proportional stratified sampling and randomly assigned to the experimental and control groups. The intervention consisted of six two-hour training sessions delivered over five modules with the integration of different CBT exercises. The effect of CBT was assessed by measuring the differences in the students' responses to a series of validated questionnaires of study variables pre-test (before the training sessions) and post-test (after the training sessions). Clinical registration was completed at ClinicalTrial.gov (ID: NCT04319393). RESULTS: Overall, using CBT techniques led to significant improvements in the study outcomes. At postintervention, the nurses who had received CBT training had significantly better self-esteem and interpersonal relationships, a greater sense of symbolic immortality, and less death anxiety and ageism than the nurses in the control group. CONCLUSIONS: CBT is an effective evidence-based psychological intervention for relieving nurses' ageism towards older adults. The psychological well-being of nurses caring for older adults is crucial, and new techniques should be adopted to relieve nurses' accumulated stress and decrease their death anxiety. Future studies which investigate the effectiveness of CBT on other forms of discrimination, such as racism and sexism in healthcare settings, are recommended.

Nurse-Led Randomized Controlled Trials in the Perioperative Setting: A Scoping Review.

PURPOSE: Nurses provide care at each phase of the complex, perioperative pathway and are well placed to identify areas of care requiring investigation in randomized controlled trials. Yet, currently, the scope of nurse-led randomized controlled trials conducted within the perioperative setting are unknown. This scoping review aims to identify areas of perioperative care in which nurse-led randomized controlled trials have been conducted, to identify issues impacting upon the quality of these trials and identify gaps for future investigation. METHODS: This scoping review was conducted in reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Searches were conducted in PubMed, Embase, Cumulative Index for Nursing and Allied Health Literature and the Cochrane Central Register of Controlled Trials, with a date range of 2014-19. Sources of unpublished literature included Open Grey, and ProQuest Dissertation and Theses, Clinical Trials.gov and the Australian and New Zealand Clinical Trials Registry. After title and abstract checking, full-text retrieval and data extraction, studies were appraised using the Joanna Briggs Institute Critical Appraisal Checklists for randomized controlled trials. Data were synthesized according to the main objectives. Key information was tabulated. RESULTS: From the 86 included studies, key areas where nurses have led randomized controlled trials include patient or caregiver anxiety; postoperative pain relief; surgical site infection prevention: patient and caregiver knowledge; perioperative hypothermia prevention; postoperative nausea and vomiting; in addition to other diverse outcomes. Issues impacting upon quality (including poorly reported randomization), and gaps for future investigation (including a focus on vulnerable populations), are evident. CONCLUSION: Nurse-led randomized controlled trials in the perioperative setting have focused on key areas of perioperative care. Yet, opportunities exist for nurses to lead experimental research in other perioperative priority areas and within different populations that have been neglected, such as in the population of older adults undergoing surgery.

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

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

Effectiveness of a Brief Psychological Intervention Delivered by Nurse for Depression in Pregnancy: Study Protocol for a Multicentric Randomized Controlled Trial from India.

BACKGROUND: Perinatal depression (PD) has important implications for maternal and infant well-being but largely goes undetected. There is a need to develop low-intensity psychosocial interventions applicable to obstetric health care facilities. OBJECTIVE: To assess the effectiveness of a brief psychological intervention for mild to moderate PD delivered by a nurse as compared to treatment-as-usual (TAU). METHODS: This study is a randomized, open-label, parallel-group, multicentric trial being conducted in four sites of India. A total of 816 pregnant women with mild to moderately severe depression (Patient Health Questionaire-9 score of 5-19) are being assessed for the effectiveness of the intervention. Participants are randomly allocated to two groups of trial intervention (psychological intervention given by nurse) and TAU. The primary outcome is to compare the proportion of women reporting improvement across both groups. Participants are serially followed-up in each trimester and at 6, 10, 14 weeks, and 6 months postpartum. Secondary outcomes include pregnancy outcomes, feeding practices, physical growth, and immunization status of the infants. CONCLUSION: It is a prospective pregnancy birth cohort with a robust design and long-term follow-up. This is one of the largest studies utilizing non-specialist health workers for the screening and management of PD. This study also holds promise to cast light on the course and outcome of depression during pregnancy in different parts of India. It is envisaged to help in developing a sound screening and referral-based protocol for obstetric settings.

A Randomized Controlled Trial Evaluating the Effectiveness of Face-to-Face and Digital Training in Improving Child Mental Health Literacy Rates in Frontline Pediatric Hospital Staff.

Background: Children with chronic physical health conditions are up to six times more likely to develop a mental health condition than their physically well peers. Frontline pediatric hospital staff are in a good position to identify mental health problems and facilitate appropriate support for patients. To date, no evaluation of mental health literacy training has taken place with this professional group to enable early identification of difficulties. It is also not known whether face-to-face or digital training is more effective or preferable in this setting. To improve the skills of frontline hospital staff, a face-to-face and digital mental health literacy training course was delivered using MindEd content and evaluated in a randomized controlled trial. Method: Two-hundred and three frontline staff across different professions from a tertiary pediatric hospital were randomized to a face-to-face (n = 64), digital (n = 71), or waitlist control group (n = 68). Face-to-face training was two and a half hours and digital training took ~1 h. The effects of training were evaluated pre- and post-training and at two-week follow-up. Questionnaires assessed mental health knowledge, stigma, confidence in recognizing concerns and knowing what to do, actual helping behavior, as well as training delivery preference, completion rate, and satisfaction. Results: Both face-to-face and digital training increased mental health knowledge, confidence in recognizing mental health problems and knowing what to do compared to waitlist controls. Digital training increased actual helping behavior relative to the waitlist controls and stigma decreased across all groups. Staff were satisfied with both delivery methods but preferred face-to-face training. Conclusions: The results provide promising findings that digital content is an effective way of improving mental health literacy in frontline pediatric hospital staff. Providing digital training could be a time-efficient way of upskilling non-mental health professionals to identify mental health needs in a pediatric population and facilitate access to appropriate care.