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The 68th World Health Assembly, in 2015, called for surgical and anaesthesia services strengthening. Acknowledging the healthcare staff shortages, they referred to task sharing, among others, as a more effective use of the healthcare workforce. While task sharing has been increasingly proposed as an important strategy to increase the reach and safety of anaesthesia as well as a means of supporting the workforce in low-resource settings, most data on task sharing relate to non-anaesthetic healthcare contexts. The aim of this study was to understand anaesthetic task sharing as currently experienced and/or envisaged by non-physician anaesthesia providers in Zambia and Somaliland.
An exploratory qualitative research methodology was used. Participants were recruited initially via contacts of the research team, then through snowballing using a purposive sampling strategy. There were 13 participants: 7 from Somaliland and 6 from Zambia. Semistructured interviews took place synchronously, then were recorded, anonymised, transcribed and analysed thematically. Triangulation and respondents’ validation were used to maximise data validity.
Four major themes were identified in relation to task sharing practices: (1) participants recognised variable components of task sharing in their practice; (2) access to task sharing depends both on sources and resources; (3) implicit barriers may inhibit task sharing practices; (4) there is an appetite among participants for amelioration of current task sharing practices.
Empowering task sharing practices can be achieved only by understanding how these practices work, by identifying gaps and areas of improvement, and by addressing them. The findings from this exploratory study could help the global community understand how anaesthetic task sharing in low-resource settings works and inspire further research on the field. This could inform future modelling of workforce planning strategies in low-resource settings to maximise the effectiveness and professional well-being of the workforce.
Skin Cutaneous Melanoma (SKCM) is a form of cancer that originates in the pigment-producing cells, known as melanocytes, of the skin. Delay wound healing is often correlated with the occurrence of and progression of SKCM. In this comprehensive study, we investigated the intricate roles of two important wound healing genes in SKCM, including Matrix Metalloproteinase-2 (MMP2) and Matrix Metalloproteinase-9 (MMP9). Through a multi-faceted approach, we collected clinical samples, conducted molecular experiments, including RT-qPCR, bisulphite sequencing, cell culture, cell Counting Kit-8, colony formation, and wound healing assays. Beside this, we also used various other databases/tools/approaches for additional analysis including, UALCAN, GEPIA, HPA, MEXPRESS, cBioPortal, KM plotter, DrugBank, and molecular docking. Our results revealed a significant up-regulation of MMP2 and MMP9 in SKCM tissues compared to normal counterparts. Moreover, promoter methylation analysis suggested an epigenetic regulatory mechanism. Validations using TCGA datasets and immunohistochemistry emphasized the clinical relevance of MMP2 and MMP9 dysregulation. Functional assays demonstrated their synergistic impact on proliferation and migration in SKCM cells. Furthermore, we identified potential therapeutic candidates, Estradiol and Calcitriol, through drug prediction and molecular docking analyses. These compounds exhibited binding affinities, suggesting their potential as MMP2/MMP9 inhibitors. Overall, our study elucidates the diagnostic, prognostic, and therapeutic implications of MMP2 and MMP9 in SKCM, shedding light on their complex interplay in SKCM occurrence and progression.
Keloid are a fibroproliferative disorder caused by abnormal healing of skin, specifically reticular dermis, when subjected to pathological or inflammatory scars demonstrating redness, elevation above the skin surface, extension beyond the original wound margins and resulting in an unappealing cosmetic appearance. The severity of keloids and risk of developing keloids scars are subjected to elevation by other contributing factors such as systemic diseases, general health conditions, genetic disorders, lifestyle and natural environment. In particular, recently, daily physical work interpreted into mechanical force as well as the interplay between mechanical factors such as stress, strain and stiffness have been reported to strongly modulate the cellular behaviour of keloid formation, affect their location and shape in keloids. Herein, we review the extensive literature on the effects of these factors on keloids and the contributing predisposing mechanisms. Early understanding of these participating factors and their effects in developing keloids may raise the patient awareness in preventing keloids incidence and controlling its severity. Moreover, further studies into their association with keloids as well as considering strategies to control such factors may help clinicians to prevent keloids and widen the therapeutic options.
Nurses' vigor at work profoundly impacts the quality of patient care. However, the determinants of nurses' vigor remain underexplored in the current nursing literature, and the mechanism through which these determinants exert their effects remains unclear.
This study aimed to elucidate the mediating role of psychological ownership in linking decent work to nurses' vigor at work.
A two-wave, time-lagged study was conducted to collect data from 289 nurses working across three hospitals in Port Said, Egypt, between March and June 2023. Data were collected using the Decent Work Scale, the Psychological Ownership Scale, the Shirom–Melamed Vigor Measure, on an Introductory Information Form. Mediation testing was performed using structural equation modeling.
Decent work was significantly associated with psychological ownership and vigor at work. Psychological ownership partially mediated the relationship between decent work and nurses' vigor at work.
Decent work practices are critical in fostering nurses' vigor while working, and psychological ownership plays a mediating role in this relationship.
Hospital administrators should value decent work practices, which could enhance psychological ownership, resulting in a potential improvement in nurses' vigor at work.
Diabetic foot ulcers (DFUs) pose a significant clinical challenge, often leading to amputations and hospitalisation. This study aimed to investigate the characteristics and outcomes of DFUs treated with surgical debridement and standardised wound care. This descriptive cross-sectional study focused on diabetic patients with appropriate vascular conditions, as determined by an Ankle Brachial Index >0.9. Based on their infection status, participants were admitted to Poursina Hospital in Rasht, Iran, and subjected to initial supportive measures, antibiotic therapy and surgical debridement. The study incorporated primary treatment with wet bandages, silver spray and fibrinolysin ointment. Statistical analysis employed SPSS 22 software. Most patients were male (54.7%) and under 60 years old (50.7%). Overweight status was prevalent in 69.3% of diabetic ulcer patients, amongst whom 48% underwent wrist debridement. The 64% and 36% of the cases had grade III and grade II Texas index. Moreover, 96% of patients exhibited signs of infection and were classified as Stage Texas B. Reoperation was necessary for 34.7% of patients. The mean hospital stay was 8.5 ± 7.55 days, and the average recovery time was 15.2 ± 15.19 days. Out of 75 patients, 10 were unable to return to limb function due to disability. In this study, around one-third of patients required secondary repair with grafts and flaps. A small number of them were unable to recover because of underlying disability, and the mean recovery time in other cases was 24 days. Future studies should follow up with patients for longer periods to assess long-term therapeutic outcomes and quality of life.
This study explores the experiences of interprofessional collaboration of Canadian midwives and obstetricians from midwives' perspective.
A concurrent mixed-methods approach that combined a small validation study and qualitative thematic analysis was used to provide evidence of the nature and importance of collaboration between Registered Midwives (RMs) and obstetricians.
Eighteen RMs across Canada completed a demographic survey and the Midwifery-Obstetrician Collaboration (MOC) scale in 2023. The quantitative analyses were conducted to assess the reliability of the Midwifery-Obstetrician Collaboration (MOC) and accumulate preliminary evidence to support its validity. Semi-structured interviews were conducted with 13 participants. After completing the interviews, themes were identified using thematic analysis.
The primary themes identified were knowledge of midwifery scope affects collaboration, collaboration is necessary for effective patient care, midwife-physician collaboration is impacted by power differentials and hierarchies, and proposed methods to improve physician-midwife collaboration. Although a small sample size did not permit extensive statistical testing, the quantitative results supported the reliability of the MOC scale. In addition, a strong correlation between the MOC and the communication subscale of the Inter-Professional Collaboration (IPC) scale provided evidence of the MOC's concurrent validity as a measure of collaboration between midwives and physicians.
This study provides support for the Midwifery-Obstetrics Collaboration (MOC) Scale as an assessment tool to evaluate collaboration between midwives and OB/GYNs in obstetrics care. While the 18 RMs recruited for this study provided a fulsome analysis for the qualitative portion, a larger study is necessary to provide more extensive quantitative analysis to validate the MOC scale for continued use among RMs and OBs.
The implications of this study are to foster strong interprofessional relationships between midwives and OBs and to improve the health outcomes of pregnant women and newborns.
The authors adhered to Consolidated criteria for reporting qualitative research (COREQ).
The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.
Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.
Participants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.
Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.
Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.
This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.
Common goals for procedural sedation are to control pain and ensure the patient is not moving to an extent that is impeding safe progress or completion of the procedure. Clinicians perform regular assessments of the adequacy of procedural sedation in accordance with these goals to inform their decision-making around sedation titration and also for documentation of the care provided. Natural language processing could be applied to real-time transcriptions of audio recordings made during procedures in order to classify sedation states that involve movement and pain, which could then be integrated into clinical documentation systems. The aim of this study was to determine whether natural language processing algorithms will work with sufficient accuracy to detect sedation states during procedural sedation.
A prospective observational study was conducted.
Audio recordings from consenting participants undergoing elective procedures performed in the interventional radiology suite at a large academic hospital were transcribed using an automated speech recognition model. Sentences of transcribed text were used to train and evaluate several different NLP pipelines for a text classification task. The NLP pipelines we evaluated included a simple Bag-of-Words (BOW) model, an ensemble architecture combining a linear BOW model and a “token-to-vector” (Tok2Vec) component, and a transformer-based architecture using the RoBERTa pre-trained model.
A total of 15,936 sentences from transcriptions of 82 procedures was included in the analysis. The RoBERTa model achieved the highest performance among the three models with an area under the ROC curve (AUC-ROC) of 0.97, an F1 score of 0.87, a precision of 0.86, and a recall of 0.89. The Ensemble model showed a similarly high AUC-ROC of 0.96, but lower F1 score of 0.79, precision of 0.83, and recall of 0.77. The BOW approach achieved an AUC-ROC of 0.97 and the F1 score was 0.7, precision was 0.83 and recall was 0.66.
The transformer-based architecture using the RoBERTa pre-trained model achieved the best classification performance. Further research is required to confirm the that this natural language processing pipeline can accurately perform text classifications with real-time audio data to allow for automated sedation state assessments.
Automating sedation state assessments using natural language processing pipelines would allow for more timely documentation of the care received by sedated patients, and, at the same time, decrease documentation burden for clinicians. Downstream applications can also be generated from the classifications, including for example real-time visualizations of sedation state, which may facilitate improved communication of the adequacy of the sedation between clinicians, who may be performing supervision remotely. Also, accumulation of sedation state assessments from multiple procedures may reveal insights into the efficacy of particular sedative medications or identify procedures where the current approach for sedation and analgesia is not optimal (i.e. a significant amount of time spent in “pain” or “movement” sedation states).
by Mamaru Melkam, Demeke Demilew, Tilahun Kassew, Biruk Fanta, Sewbesew Yitayih, Kassahun Alemu, Yassin Muhammed, Berhanie Getnet, Eden Abetu, Gebrekidan Ewnetu Tarekeg, Mohammed Oumer, Goshu Nenko
IntroductionAnxiety disorder is an unpleasant emotional feeling with symptoms related to psychological and autonomic symptoms such as headache, perspiration, palpitations, dizziness, and stomach discomfort. The use of substances become a worldwide problem among youth which brings situation that leads to serious social and health-related problems. Anxiety disorders with substance use have a huge impact on their high prevalence, therapeutic issues, and poor prognosis on clinical effects. Although the prevalence of anxiety disorders is significant among young people who use substances, limited studies were conducted. Therefore, this study revealed the burden of anxiety disorders among youth with substance use and associated factors in Ethiopia.
MethodA community-based multi-stage with a simple random sampling technique was conducted. A total of 372 substance users study participants were recruited for this study. Alcohol, Smoking, and Substance Involvement Screening Tests, Depression Anxiety Stress Scales, and other tools were used to assess anxiety disorders with substance use and associated factors. Data were entered into Epi-data version 4.6, and exported to SPSS version 20 for further analysis. Bi-variables logistic regression analysis was employed to identify variables with a p-value of Results
From a total of 372 respondents the overall prevalence of anxiety disorders with substance use was 48.1%. Male sex [AOR = 1.99; 95% CI: (1.01–3.93)], low educational status of the father [AOR = 6.38 95%CI: (1.50–7.08)], and the presence of stress [AOR = 2.48; 95% CI: 2.48(2.43–4.40)] were significantly associated factors with anxiety disorders with substances use.
Conclusions and recommendationsThe prevalence of anxiety disorders with substance use was 48.1% therefore; it is recommended that the zonal administration give collaborative work with the health bureau and facilitate awareness creation about the impact of substance abuse. Clinicians are recommended to mitigate anxiety disorders with substance use to get a good prognosis for clients with controlling their stress.
Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.
To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.
Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (
Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p
There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.
To synthesise evidence from studies that explored the impact of electronic and self-rostering systems to schedule staff on healthcare organisations and healthcare workers.
Mixed-method systematic review.
Studies were screened by two independent reviewers and data were extracted using standardised data extraction tables. The quality of studies was assessed, and parallel-results convergent synthesis was conducted.
Academic Search Complete, CINAHL, ERIC, MEDLINE, PsycINFO and PsycARTICLES were searched on January 3, 2023.
Eighteen studies were included (10 quantitative descriptive studies, seven non-randomised studies and one qualitative study). Studies examined two rostering interventions including self-rostering (n = 12) and electronic rostering (n = 6). It was found that the implementation of electronic and self-rostering systems for staff scheduling impacted positively on both, healthcare workers and healthcare organisations. Benefits included enhanced roster efficiency, staff satisfaction, greater control and empowerment, improved work-life balance, higher staff retention and reduced turnover, decreased absence rates and enhanced healthcare efficiency. However, self-rostering was found to be less equitable than fixed rostering, was associated with increased overtime, and correlated with a higher frequency of staff requests for shift changes.
The impact of electronic and self-rostering systems to schedule staff on healthcare organisations and healthcare workers’ outcomes was predominantly positive. Further randomised controlled trials and longitudinal studies are warranted to evaluate the long-term impact of various rostering systems, including electronic and self-rostering systems.
Rostering is a multifaceted responsibility for healthcare administrators, impacting patient care quality, workforce planning and healthcare expenditure.
Given that healthcare staffing costs constitute a substantial portion of global healthcare expenditure, efficient and strategic resource management, inclusive of healthcare staff rostering, is imperative.
The 27-item Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist.
No Patient or Public Contribution.
Pressure ulcers are one of the leading complications in bedridden patients that result in multiple burdens on healthcare systems and patients (11 billion dollars/year). The prevalence of pressure ulcers in traumatic brain injury patients is 1.5-fold compared with the other bedridden patients. Moreover, critical traumatic brain injury patients who are admitted to the intensive care unit experience severe pressure ulcers and further complications. The motor/sensory disabilities and low supplementation and oxygenation to the pressured side were the main mechanisms of the typical pressure ulcers. Intellectual evaluation is the first essential step to prevent the development of pressure ulcers in high-risk patients. Till now, different scales, including Injury Scale Score and Braden Scale Score, have been provided to assess the pressure ulcer. Since low stages of pressure ulcers heal rapidly, traumatic brain injury patients require a periodical assessment to prevent further developments timely. Alongside different procedures provided to prevent and treat any pressure ulcer, traumatic brain injury patients required additional specific protections. For the first line, fast and efficient rehabilitation repairs motor/sensory disabilities and decreases the chance of pressure ulcer. Our review indicated that pressure ulcer in traumatic brain injury had several complex mechanisms that demand special care. Therefore, further studies are required to address these mechanisms and prevent their progression to typical and atypical pressure ulcers.
Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.
In the ongoing challenge to reduce burn-associated mortality rates, this study explores the predictive capacity of clinical factors in burn patients, focusing on vitamin D, calcium, and serum albumin levels during hospitalisation in cases with Pseudomonas aeruginosa infection. Our research involves a comprehensive analysis of 100 burn patients, encompassing crucial clinical parameters such as the burn severity index, serum albumin, vitamin D, and calcium levels at admission. Data were meticulously entered into IBM Statistics SPSS software version 28 and subjected to statistical analysis. The study reveals an average patient age of 39.75 years and a notable 34% mortality rate. Additionally, the average lengths of hospital and intensive care unit (ICU) stays are determined to be 11.33 and 7.79 days, respectively. Significantly, a correlation between calcium and albumin variables and treatment outcomes is established, showcasing their potential to predict variable changes in patient mortality rates. Furthermore, a noteworthy association is observed between serum calcium levels and the duration of ICU hospitalisation. In conclusion, albumin and calcium variables emerge as sensitive and specific indicators for predicting outcomes in burn patients. Importantly, the independence of these factors from the physician's experience and diagnosis reduces human error and thus increases the accuracy of mortality prediction in this patient population.
by Afsoon Dadvar, Melika Jameie, Mehdi Azizmohammad Looha, Mohammadamin Parsaei, Meysam Zeynali Bujani, Mobina Amanollahi, Mahsa Babaei, Alireza Khosravi, Hamed Amirifard
ObjectivesCaffeine’s potential benefits on multiple sclerosis (MS), as well as on the ambulatory performance of non-MS populations, prompted us to evaluate its potential effects on balance, mobility, and health-related quality of life (HR-QoL) of persons with MS (PwMS).
MethodsThis single-arm pilot clinical trial consisted of a 2-week placebo run-in and a 12-week caffeine treatment (200 mg/day) stage. The changes in outcome measures during the study period (weeks 0, 2, 4, 8, and 12) were evaluated using the Generalized Estimation Equation (GEE). The outcome measures were the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for self-reported ambulatory disability, Berg Balance Scale (BBS) for static and dynamic balance, Timed Up and Go (TUG) for dynamic balance and functional mobility, Multiple Sclerosis Impact Scale (MSIS-29) for patient’s perspective on MS-related QoL (MS-QoL), and Patients’ Global Impression of Change (PGIC) for subjective assessment of treatment efficacy. GEE was also used to evaluate age and sex effect on the outcome measures over time. (Iranian Registry of Clinical Trials, IRCT2017012332142N1).
ResultsThirty PwMS were included (age: 38.89 ± 9.85, female: 76.7%). Daily caffeine consumption significantly improved the objective measures of balance and functional mobility (BBS; P-value Conclusions
Caffeine may enhance balance, functional mobility, and QoL in PwMS. Being male was associated with a sharper increase in self-reported ambulatory disability over time. The effects of aging on balance get more pronounced over time.
Trial registrationThis study was registered with the Iranian Registry of Clinical Trials (Registration number: IRCT2017012332142N1), a Primary Registry in the WHO Registry Network.
Despite to high burden of road traffic injuries (RTIs), the RTI epidemiology has received less attention with rare investments on robust population cohorts. The PERSIAN Traffic Safety and Health Cohort (PTSHC) was designed to assess the potential causal relationships between human factors and RTI mortality, injuries, severity of the injury, hospitalised injury, violation of traffic law as well as offer the strongest scientific evidence.
The precrash cohort study is carried out in four cities of Tabriz, Jolfa, Shabestar and Osku in East Azerbaijan province located in northwest Iran. The participants were people who sampled among the general population. The cluster sampling method was used to enrol the households in this study. The PTSHC encompasses a wide and comprehensive range and types of data. These include not only the common cohort data collections such as medical examination measures, previous medical history, bio assays and behavioural assessments but also includes data obtained using advanced novel technologies, for example, electronic travel monitoring, driving simulation and neuro-psycho-physiologic laboratory assessments specifically developed for traffic health field.
A total of 7200 participants aged 14 years and above were enrolled at baseline, nearly half of them being men. The mean age of participants was 39.2 (SD=19.9) years. The majority of participants (55.4%) belonged to the age group of 30–56 years. Currently, approximately 1 200 000 person-measurements have been collected.
PSTHC will be used to determine the human-related risk factors by adjusting for the vehicle and land-use-related factors. Therefore, a lot of crashes can be prevented using effective interventions. Although this cohort provides valuable data, it is planned to increase its size to achieve the highest level of evidence with higher generalisability. Also, according to the national agreement this cohort is going to be extended to several geographical regions in second decade.
Menopausal women often complain of a range of physical and psychological symptoms known as menopausal syndrome. These symptoms are associated with fluctuating hormone levels, sleep disturbances, and mood swings.
This study aimed to examine the efficacy of a program-based cognitive behavioral group therapy (CBT) for insomnia and depression among women experiencing menopause.
A randomized controlled trial of 88 women experiencing menopause was conducted in Egypt from June to September 2022 in outpatient clinics at Mansoura University Hospitals in Egypt. Participants were randomly assigned to a control group (45 women) and an intervention group (43 women). The intervention group received 7 weeks of CBT sessions. Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory 2nd Edition (BDI-II) were administered before and after the intervention.
In the intervention group, there was a significant difference in scores of the subdomains of PSQI, including sleep efficiency, daytime dysfunction, subjective sleep quality, and sleep disturbance (t = 8.911, 11.77, 7.638, and 11.054, respectively), while no significant difference in domains of using sleep medication, sleep duration, and sleep latency. Significant improvements were observed between pre-and-post-intervention in the intervention group for the total scores of PSQI, ISI, and BDII-II (t = 12.711, 16.272, and 12.384, respectively), indicating a large effect size for the three studied variables (r = .81, .87, .8, respectively).
This study demonstrated the efficacy of group CBT for lowering insomnia and depression in women experiencing menopause. Thus, results indicated the need of considering prompt and appropriate interventions such as CBT as a safe treatment option to prevent the aggravation of sleep and emotional problems for menopausal women.
ClinicalTrials.gov Identifier: NCT05920460.
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