BACKGROUND: Although research interest in fear of childbirth has increased, interventions targeting especially multiparas with fear of childbirth have been overlooked, although untreated fear can cause serious adverse effects on the mother and the whole family. Thus MOTIVE (Multiparas overcoming Childbirth Fear Through Intervention and Empowerment), an intervention for pregnant multiparas with fear of childbirth, was designed.
METHODS: This is a protocol of a single-arm non-randomized feasibility study of the MOTIVE trial with a mixed-methods design. The primary aim of the intervention is to assist pregnant multiparas with fear of childbirth, with the desired outcome to alleviate fear. MOTIVE consists of four group sessions (2 h each); three during pregnancy and one after giving birth and in addition of a phone call after birth. The intervention is provided by a midwife and a psychiatric nurse at the maternity hospital. Quantitative data will be gathered via self-report questionnaires at three time points, at baseline, at 4 weeks post-baseline and post-intervention. Qualitative data will be gathered by diaries, open-ended questions from post-intervention questionnaires, and individual interviews. The target is to assemble four groups of four multiparas over a 12-month period.
CONCLUSIONS: The findings will provide insights into the feasibility and acceptability of the intervention and will inform revisions to it. The results will guide the development of a definitive, larger-scale trial evaluation to further examine the efficacy of the refined intervention.

The low incidence of vincristine-induced peripheral neuropathy (VIPN) in Kenyan children may result from low vincristine exposure. We studied vincristine exposure in Kenyan children and dose-escalated in case of low vincristine exposure (NCT05844670). Average vincristine exposure was high. Individual vincristine exposure was assessed with a previously developed nomogram. A 20% dose increase was recommended for participants with low exposure and no VIPN, hyperbilirubinemia, or malnutrition. None of the 15 participants developed VIPN. Low vincristine exposure was seen in one participant: a dose increase was implemented without side effects. In conclusion, the participants did not develop VIPN despite having high vincristine exposure.

Early career professionals (ECPs) are a critical target for physical activity (PA) promotion. Affect contributes to an established PA intention-behaviour gap and is pertinent among ECPs.
UNASSIGNED: The purpose of this study was to examine the feasibility and acceptability of a web-based intervention and explore the effects on secondary outcomes (moderate-to-vigorous PA (MVPA), emotion regulation, multi-process action control constructs).
UNASSIGNED: Adults aged 25-44 who were employed at least part-time in a desk-based job and not meeting PA guidelines (<150 min MVPA) were recruited and randomized into a 6-week online intervention integrating acceptance and commitment principles and affect regulation strategies, or a control group.
UNASSIGNED: Forty adults were recruited and randomized to the web-based intervention (n = 21) and waitlist control (n = 19). The recruitment rate was 29%, retention was 75%, engagement was 68%, and satisfaction was high in both quantitative and qualitative assessment. Participants allocated to the intervention improved MVPA (ηp2=0.30), emotion regulation (ηp2 =0.49), behavioural regulation (ηp2=0.53), affective attitude (ηp2=0.23), identity (ηp2=0.24), and constructs of mindfulness (ηp2=0.44), and valued living (ηp2=0.20).
UNASSIGNED: Primary outcomes concerning feasibility were adequate and secondary outcomes improved, suggesting a full-scale randomized controlled trial is feasible with minor modifications. A large-scale study is warranted to establish intervention effectiveness.

BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.
OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
BACKGROUND: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
UNASSIGNED: RR1-10.2196/13642.

BACKGROUND: The purpose of this study was to examine the feasibility of adapting and translating an evidence-based occupational therapist-delivered program shown to be effective in the community to residential aged care (RAC). The program aims to improve quality of care and quality of life for people living with dementia and the wellbeing of the family care partner.
METHODS: This study took place in a not-for-profit RAC home in Adelaide, South Australia. Mixed methods, specifically questionnaires, activity logs, focus group, and one-on-one interviews were used to evaluate the feasibility of the program implementation. Staff working in the participating home, occupational therapists trained to deliver the program, and residents and their family carer partners were included. Quantitative data were analysed using proportions, means, and standard deviations. Qualitative data were analysed using a thematic approach.
UNASSIGNED: This study was conducted together with a consumer (person living with dementia) and a carer representative (family member of someone residing in RAC). These representatives provided input towards the study design, interpretation of study data, discussion of results, and recommendations for future consideration.
RESULTS: Small changes to the program improved feasibility and acceptability for delivery in RAC. While the care home staff required added support during implementation, the intervention therapists felt that the program could be delivered in this setting. Family care partners of residents with dementia felt that the program may be better suited if provided upon entry to RAC or in early stages of dementia.
CONCLUSIONS: Adapting a community-based dementia care program to RAC can be safe and feasible. Program adaptations are necessary for feasibility. Further adaptations and evaluations of associated outcomes (related to residents with dementia and their family care partners) are needed to assess the program effectiveness in larger scale.
CONCLUSIONS: Spending quality time with family members in residential aged care is important. However, many struggle to know what to say or do when visiting a family member who lives with dementia. Programs that teach families about how to communicate with people living with dementia, how to support them to take part in important everyday living activities, or how to understand why changes in behaviours may occur have not been available in residential aged care. This paper describes how we adapted one such evidence-based program from community to residential aged care settings. We consulted with people living with dementia, carers, and families and found that the program could also be valuable in this care setting. Residential aged care staff described how the program is very different to what is usually available in residential aged care, but they were optimistic that with the right support, it could be a valuable way to support residents with dementia and their families. Family members of residents with dementia and therapists delivering the program felt that residents in early stages of living in residential aged care and/or early stages of dementia could benefit the most from these programs. We found that including family members in the intervention process can be useful and empowering for families and residents. Future work should also focus on involving other staff members caring for residents in the process. Communication between staff and families is the key for program delivery and success and treating each person as an individual.

OBJECTIVE: To assess first-trimester recruitment and retention of pregnant patients who regularly used cannabis, but not other substances, measured by willingness to participate in a research study, completion of self-administered electronic questionnaires, and willingness to provide urine samples during each trimester of pregnancy. We designed and launched a prospective feasibility study titled, Cannabis Legalization in Michigan (CALM) - Maternal & Infant Health (MIH), in two Michigan clinics after the recreational use of cannabis became legal for adults 21 years and older.
RESULTS: Over half (52%) of patients asked to participate in CALM-MIH were consented to the study. Two-thirds (66%) of screened patients initiated prenatal care during their first trimester of pregnancy and 50% used cannabis, of which the majority did not concurrently use other substances. Of those recruited into the prospective study, all participants completed the first-trimester questionnaire and provided urine samples. Study retention was 80% and all participants who completed follow-up assessments were willing to provide urine samples.

BACKGROUND: Dental caries remains a significant problem in England, affecting 11% of 3-year-olds and 23% of 5-year-olds. While current approaches have been extensively investigated, their ability to (1) control pain and infection; (2) prevent hospital admissions, and (3) be implemented within the National Health Service (NHS) contractual arrangements, remains unsatisfactory. Silver diamine fluoride (SDF) is an alternative, non-invasive approach that has proven efficacy in arresting caries progression in primary teeth, principally from studies conducted outside of Europe. Its use in primary dental care in the UK is limited, despite the acknowledged need. The clinical and cost-effectiveness of SDF has not been compared to usual care in the UK. Before a pragmatic randomised controlled trial (RCT) can be conducted to compare SDF to usual care for caries management in young children, there are several uncertainties that require investigation. This study aims to establish whether such an RCT is feasible.
METHODS: This mixed-method parallel design study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with 13 dentists and therapists, in 8 different dental primary care sites with a sample size of 80 child participants aged 1-8 years old. The aim will be to recruit ten participants per site with equal arm allocation. Follow-up will be for 1 year. The study will inform whether an RCT is feasible by resolving several key uncertainties. The acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement representatives will be involved throughout recruitment and retention strategies, participant documentation, analysis, engagement and dissemination.
CONCLUSIONS: The ability to conduct an RCT will be evaluated. If feasible, this RCT has the potential to evaluate the effectiveness of a non-invasive approach for the management of untreated caries in young children. A feasibility study also offers the opportunity to consider factors associated with the implementation of SDF at an early stage through a process evaluation that will inform the definitive trial and an implementation strategy for SDF by identifying relevant barriers and facilitators.
BACKGROUND: ClinicalTrials.gov identifier: NCT06092151. Date: 19/10/2023.

BACKGROUND: The global aging population presents challenges that are particularly acute in China. Older Chinese adults\' attitudes towards death significantly impact their quality of life. Death education is crucial for promoting positive perspectives on life and death. Narrative education offers a promising approach to facilitating death education. Integrating the Knowledge-Attitude-Practice (KAP) model into death education will enhance the feasibility and acceptability of death education programs.
METHODS: This mixed-methods feasibility study included a quasi-experimental trial and semi-structured interviews. Older adults in the intervention group (N = 27) received a 6-week KAP-based narrative life education program in addition to standard community health education; participants in the control group (N = 20) received only the normal community health education. In both groups, attitudes toward death and the meaning of life were assessed at baseline and immediately after the intervention. A post-intervention semi-structured interview and satisfaction survey were also conducted for the intervention group.
RESULTS: Forty out of 47 older adults completed the program for an 85.1% retention rate. All of the older adults in the experiment were very satisfied and satisfied with the life education program, and no adverse events were reported. Compared to the control group, participants in the intervention group had a significant decrease in the fear of death (P = 0.028), and substantial improvement in their value of life (P = 0.031), goal of life (P = 0.035), freedom of life (P = 0.003), and the total score for purpose in life (P = 0.017). The qualitative results yielded four themes: profound recognition of life and death, contradiction between thoughts and action, conflict between one\'s acceptance and others\' avoidance, and evaluation of the life education program.
CONCLUSIONS: The KAP-based narrative life education program is feasible and acceptable for older Chinese community-dwelling adults. It is also potentially effective in improving attitudes toward death attitudes and the meaning of life in this cohort.
BACKGROUND: This study was retrospectively registered at China Clinical Trial Registry as ChiCTR2300069551 on 2023-03-20. URL of registration: https://www.chictr.org.cn/showproj.html?proj=183176 .

Home exercise programs are beneficial in managing frozen shoulder (FS), yet adherence remains challenging. This pilot study introduces the remote app, Defrozen, designed for home exercises and assesses its feasibility and clinical outcomes in FS patients undergoing intra-articular and sub-acromial corticosteroid treatment. Over a four-week period, patients used the Defrozen-app, engaging in guided exercises. The feasibility of the intervention was assessed through several measurement scales, including adherence, the Technology Acceptance Model 2 (TAM2), the System Usability Scale (SUS), and User Satisfaction and Engagement (USE). Clinical outcomes included pain scale, Oxford Shoulder Score (OSS), Quick Disability of the Arm, Shoulder, and Hand (QuickDASH) Score, and passive range of motion. The TAM2 results indicated high perceived usefulness (4.5/5), ease of use (4.8/5), and intention to use (4.4/5); the SUS score was high at 81.7/100, complemented by USE scores reflecting ease of learning (4.9/5) and satisfaction (4.3/5). Clinical outcomes showed significant pain reduction, improved shoulder function, reduced shoulder-related disability, and increased shoulder range of motion. These findings suggest the Defrozen-app as a promising solution for FS, significantly improving adherence and showing potential to enhance clinical outcomes. However, these clinical outcome results are preliminary and necessitate further validation through a large-scale randomized controlled trial to definitively confirm efficacy and assess long-term benefits.

The extent to which group therapy benefits individuals who have experienced couple infidelity remains unexamined. In this study, a brief group intervention for individuals who experienced couple infidelity was designed, and the feasibility of the intervention was evaluated (i.e., acceptability; implementation; measurements\' performance and, limited-efficacy testing). The final sample was composed of 20 women and 4 men (M = 29.95 years, SD = 12.3). Twenty-four completed pre and post assessments and 20 of these completed the follow-up assessment. At pre, post, and follow-up, participants responded to a questionnaire packet that included measures of depression, anxiety and PTSD symptoms, relationship self-efficacy, centrality of event, cognitive fusion, and decision to forgive. Also, follow-up interviews were conducted. The closed group intervention consisted of eight 90-min weekly sessions. The group therapy process component was based on solution-focused therapy. Psychoeducation component included mindfulness, reflection on personal values, factors that contribute to infidelity, and forgiveness. Session rating scores indicated an overall high acceptance of the intervention, its contents, and goals. Interview reports showed that dealing with thoughts and emotions, understanding infidelity, and forgiveness were the most helpful contents. Group support and processes were also positively valued. Repeated-measures MANOVA results indicated statistically significant decrease in symptoms, cognitive fusion, and importance of the event, as well as an increase in self-efficacy. Measurement instruments showed adequate reliability. These results indicate that a group treatment may be an alternative format to help individuals deal with psychological consequences of couple infidelity, when couple therapy is not possible.