Reducing rural isolation through music: telehealth music therapy for community dwelling people living with dementia and their family caregivers in rural Ireland.

INTRODUCTION: Since the outset of COVID-19, we have become more reliant on technology to stay connected to others. Notable benefits of telehealth have been observed, including increased access to health and community support services for community dwelling people living with dementia and their family caregivers and diminishing barriers such as geographical location, mobility issues and increased cognitive decline. Music therapy is an evidence-based intervention for people living with dementia and has been proven to promote improved quality of life, increase social interaction and provide a form of meaningful communication and expression when language becomes difficult. This project is one of the first internationally to pilot telehealth music therapy for this population. METHODS: This mixed methods action research project has six iterative phases of planning, research, action, evaluation, and monitoring. Public and Patient Involvement (PPI) has been sought from members of The Dementia Research Advisory Team at the Alzheimer Society of Ireland at all stages of the research process to ensure the research remains relevant and applicable to those with dementia. The presentation will briefly outline the phases of the project. RESULTS: Preliminary results from this ongoing research suggest that there is feasibility for telehealth music therapy to provide psychosocial support to this population. Collaboration with PPI contributors resulted in the following research priorities: (1) ensuring a person-centered approach; (2) advanced care planning using music; and (3) the signposting of music related supports for community dwelling people living with dementia. Music therapy is being piloted currently and preliminary results will be outlined. DISCUSSION: Telehealth music therapy has the potential to complement existing rural health and community services for people living with dementia, in particular addressing social isolation. Recommendations regarding the relevance of cultural and leisure pursuits on health and well-being of people living with dementia will be discussed, particularly the development of online access.

Novel Screening Tool and Considerations for Music Therapists Serving Autistic Individuals via Telehealth: Qualitative Results from a Survey of Clinicians' Experiences.

During the COVID-19 pandemic, music therapists transitioned services from in-person to telehealth due to health and safety concerns. Though online delivery of music therapy services for autistic individuals occurred prior to 2020, the number of North American music therapists using telehealth with autistic clients rose substantially during the pandemic. The current paper's objective was to delineate music therapists' perceptions regarding factors that helped or hindered autistic persons' engagement in online music therapy sessions. In total, 192 participants completed the survey. Qualitative content analysis of an open-ended question identified seven overarching themes regarding the benefits and challenges of telehealth music therapy for autistic clients. Findings were used to create a screening tool to help music therapists evaluate autistic persons' suitability for telehealth and meet the needs of those who can benefit from telehealth music therapy.

Exploring Influencing Factors of Anxiety Improvement Following Mindfulness-Based Music Therapy in Young Adults with Cancer.

The purpose of this secondary analysis was to explore physiological, psychological, and situational influencing factors that may affect the impact of a mindfulness-music therapy intervention on anxiety severity in young adults receiving cancer treatment. Young adults receiving cancer treatment for ≥ eight weeks were recruited from adult and pediatric oncology outpatient centers at Dana-Farber Cancer Institute. Participants were asked to attend up to four, in-person (offered virtually via Zoom video conference after the onset of the COVID-19 pandemic) 45-min mindfulness-based music therapy sessions over twelve weeks with a board-certified music therapist. Participants completed questionnaires about anxiety, stress, and other cancer treatment-related outcomes before and after participating in the intervention. Changes in anxiety (i.e., PROMIS Anxiety 4a) over time were compared among baseline physiological (e.g., age or sex), psychological (e.g., stress), and situational influencing (i.e., intervention delivery format) factors using Wilcoxon-rank sum tests. Thirty-one of the 37 enrolled participants completed the baseline and post-intervention measures and were eligible for inclusion in the secondary analysis. Results revealed that higher baseline physical functioning (median change = -6.65), anxiety (median change=-5.65), fatigue (median change = -5.6), sleep disturbance (median change = -5.6),female sex (median change = -5.15), or virtual intervention delivery(median change = -4.65) were potential physiological, psychological, or situational influencing factors associated with anxiety improvement following mindfulness-based music therapy. Additional investigation into physiological, psychological, or situational influencing factors associated with anxiety response will help to tailor the design of future mindfulness-music therapy interventions to decrease psychological distress and address the unique psychosocial concerns among young adults receiving cancer treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03709225.

A qualitative study on stress, coping strategies and feasibility of music intervention among women with cancer receiving chemotherapy during COVID-19 pandemic in Vietnam.

Breast and gynaecological cancer (BGC) patients receiving chemotherapy may experience high levels of stress during the COVID-19 pandemic. Music interventions may be effective in lowering their stress levels. This study explored stressors, coping strategies, and the feasibility of music interventions among BGC patients in Vietnam. An exploratory qualitative study with individual face-to-face semi-structured interviews was conducted. A convenience sample of BGC patients receiving chemotherapy was recruited from the oncology centre of a public hospital in Vietnam. Twenty patients were interviewed with open-ended questions developed based on the transactional model of stress and coping to explore stress-causing factors and coping strategies and based on guidelines for music therapy practice to explore their music preferences and perceptions. Field notes and interview transcripts were analysed following the qualitative content analysis approach. Two stressor themes were identified: undesirable experiences during treatment and patients' inability to fulfil their own roles and responsibilities. Our findings revealed a new coping strategy-self-realisation of responsibilities towards the family-that is not listed in the transactional model of stress and coping. Future psychological interventions for stress management among BGC patients should focus on raising the patients' awareness of their values and responsibilities towards their families. Three categories of preferred music genres for stress reduction were identified: religious, softly melodic, and revolutionary music. The patients were aware of the positive effects of music and had different musical preferences. This study also explored the acceptance of music interventions and facilitators and barriers to implementing them among BGC patients in Vietnam. The findings suggest that before implementing music interventions, the musical preferences, religions, and beliefs of each individual should be considered to achieve desirable results. Music interventions for BGC patients receiving chemotherapy in Vietnam are feasible. Further intervention studies are needed to evaluate their effectiveness.

Social Work Intervention for Anxiety and Depression among Medical Workers during the COVID-19 Pandemic: "Internet Plus Music Therapy".

BACKGROUND: To explore the effect of social work intervention on psychological intervention of medical workers after the epidemic under the mode of "internet plus Music Therapy". SUBJECTS AND METHODS: The observation objects in this study were all medical workers in fever clinic under the epidemic situation in COVID-19. A total of 60 cases were selected, and the proportion of anxiety and depression of medical workers in fever clinic was investigated by electronic questionnaire. After completing the investigation, social work intervention measures under the mode of "internet plus Music Therapy" were implemented. RESULTS: After implementation, the proportion of anxiety and depression of medical workers were significantly lower than those before intervention (P<0.05). The development of music therapy activities has alleviated the job anxiety of medical workers to a great extent, and the job anxiety test, total score and scores of various factors have all decreased. CONCLUSIONS: Social work intervention under the mode of "internet plus Music Therapy" can relieve anxiety and depression, and ensure the mental health of frontline medical staff during the epidemic.

Dual-Task-Based Music Therapy to Improve Executive Functioning of Elderly Patients with Early Stage Alzheimer's Disease: A Multiple Case Study.

Deficits in executive functioning are a common feature of Alzheimer's disease (AD) and result from impairment in the central executive system. As a result, elderly patients with early stage AD may require interventions that are more cognitively intense than traditional interventions. To address this need, in this multiple case study, we explored a dual-task-based music therapy intervention that involved drum playing and singing designed to induce attentional and motor controls. Three octogenarians diagnosed with early stage AD participated in 12 dual-task-based music therapy sessions over 6 weeks. Measures of executive functioning and the performance of a bimanual drum tapping task were evaluated before and after the intervention. Improvements in executive functioning were observed for participants A and C. After the intervention, reduced mean synchronization errors were found for the simultaneous tapping condition for all three participants. Although there was variability in the functional changes between participants, it is noteworthy that positive improvements in the elderly patients with early stage AD were obtained following dual-task-based music therapy. The results suggest that music therapy integrated into the dual-task paradigm can be an effective way to address degenerative cognitive deficits among elderly patients with early stage AD.

The effect of music on pain and anxiety in patients receiving chemotherapy during COVID-19.

OBJECTIVE: This research has been conducted to determine the effect of music on pain and anxiety levels of patients receiving chemotherapy during COVID-19. METHODS: The research has been carried out in a real trial model with 92 adult patients (45 in the experimental group who received chemotherapy and 47 in the control group). The data have been collected by the researcher with Google Forms (using State and Trait Anxiety Inventory [STAI] and visual analogue scale [VAS]) through the links sent to the phones of participants on the day they received chemotherapy, between March 2020 and July 2020. RESULTS: The mean scores obtained from the post-test STAI (53.11 ± 4.77) and VAS (3.44 ± 2.53) in the experimental group have been determined to statistically significantly decrease when compared to the pre-test measurement data (STAI: 54.26 ± 4.26; VAS: 4.22 ± 2.41) (p < 0.05). No statistically significant difference has been determined between pre-test and post-test mean scores of the patients in the control group. CONCLUSION: It has been observed that music applications reduce the pain and anxiety levels of patients receiving chemotherapy during the COVID-19 process. It can be recommended to use music applications in the management of pain and anxiety symptoms.

Impact of Physical Contact on Preterm Infants' Vital Sign Response to Live Music Therapy.

Evidence that music therapy stabilises vital parameters in preterm infants is growing, but the optimal setting for therapy is still under investigation. Our study aimed to quantify the effect of physical contact during live music therapy in preterm infants born < 32 weeks' gestational age (GA) on post-therapy vital sign values. Live music therapy was delivered twice-weekly until discharge from hospital to 40 stable infants < 32 weeks' GA. Baseline and post-therapy heart rate, respiratory rate, oxygen saturation and physical contact during each session were recorded. 159 sessions were performed with, and 444 sessions without, physical contact. Descriptive and multivariable regression analyses based on directed acyclic graphs were performed. The mean GA was 28.6 ± 2.6 weeks, and 26 (65%) infants were male. Mean absolute values for heart and respiratory rates lowered during music therapy regardless of physical contact. The mean post-therapy SaO2 was higher compared to baseline values regardless of physical contact (mean differences -8.6 beats/min; -13.3 breaths/min and +2.0%). There were no clinically relevant changes in vital sign responses between therapy sessions, with or without physical contact, or adjusted post-therapy values for any of the studied vital signs. Physical contact caused better baseline and post-therapy vital sign values but did not enhance the vital sign response to music therapy. Thus, the effect of music therapy on preterm infants' vital signs is independent of physical contact and parents' presence during music therapy in the neonatal intensive care unit.

Leveraging Cross-Campus Expertise to Contribute to Dementia Care Through Music.

While there is evidence of the benefits of music for health and wellness, current US clinical practice does not commonly incorporate arts-based interventions, one drawback of which appears to be limited communication among practitioners within the arts, sciences, and health professions fields. This article shares a story of a 2-year multidisciplinary music in medicine program that aims to inspire joy and connection among people with dementia through interactive, creative musical experiences. The authors discuss the program from conception to pilot, canvass adaptations made to adhere to COVID-19 protocols, illuminate common themes of flexibility and curiosity, and share cross-campus, multidisciplinary collaboration experiences that guided the work.

The Listening to music tuned to 440 Hz versus 432 Hz to reduce anxiety and stress in emergency nurses during the COVID-19 pandemic: a double-blind, randomized controlled pilot study.

BACKGROUND AND AIM: Healthcare providers in the emergency first response units have been exposed to a considerable stress during the SARS-CoV-2 pandemic. This study was designed to identify the effects of listening to music during the work break compared to the routine break (in the absence of listening to music) on the level of state anxiety and on the vital parameters of the nurses on duty at the operations center. METHODS: Randomized, controlled, three-arm, double-blind, single-center clinical study. Healthcare providers were divided into three groups according to study intervention (Group 1: listening to 440Hz music; Group 2: listening to 432Hz music; Group 3: liberal activity). The study was conducted during the working hours of dayshifts in an emergency first response unit station located in Tuscany, Italy. Outcomes were measured against measures of stress (State-Trait Anxiety Inventory - STAIX1), heart rate (HR), respiratory rate (RR), systolic/diastolic blood pressure (SBP/DBP), pain and productivity (Likert Scale) measured at baseline (T0) and at the end of exposure (T1). RESULTS: Overall, 54 healthcare providers were enrolled; 32 females (59.3%); mean age of 39.64 years (SD±9.94); the total measurements performed were 83. The median values of STAI X1 decreased in all the 3 groups from T0 to T1 (Group 1: 34.5 vs. 32, p=0.0001; Group 2: 34 vs. 29, p=0.001; Group 3: 33 vs. 31, p=0.028). In Group 2 a reduction of mean values of respiratory rate and systolic blood pressure was recorded at T1 (-2.714 b/min, p=0.000 and -3.821 mmHg, p=0.031, respectively). CONCLUSIONS: Listening to music at 432 Hz is a low cost and short intervention that can be a useful resource to manage anxiety and stress. Further studies are needed to assess medium and long-term effects of listening to music.

Light acupuncture and five-element music therapy for nurses' mental health and well-being during and post-COVID-19: protocol for a randomised cross-over feasibility study.

INTRODUCTION: Australian nurses have experienced higher levels of anxiety during the COVID-19 pandemic compared with the prepandemic. This may have affected their long-term mental health and intention to stay in the profession resulting in a workforce shortage, which further impacts the health of the public. Management is urgently required to improve nurses' well-being. However, there is limited evidence available. The proposed clinical trial aims to evaluate the feasibility and therapeutic effects of using a combination of light acupuncture and five-element music therapy to improve nurses' mental health and well-being during and post-COVID-19. METHODS AND ANALYSIS: This randomised, single blinding, two-arm cross-over feasibility study involves a 1-week run-in period, 2-week intervention and 1-week run-in period in between interventions. Thirty-six eligible nurses will be recruited from the community and randomised into either a combination of light acupuncture treatment and five-element music therapy group or no treatment group for 2 weeks. After a 1-week run in period, they will be swapped to the different group. The primary outcome of this study is to evaluate the feasibility of a combination of light acupuncture treatment and five-element music therapy to improve nurses' mental health and well-being. The secondary outcomes will include anxiety and depression, work productivity and activity, and quality of life assessments. Participants will be asked to complete a set of online questionnaires throughout the trial period. All analyses will be performed in R Studio V.1.1.463. ETHICS AND DISSEMINATION: Ethical approval was attained from Edith Cowan University's Human Research Ethics Committee (No. 2021-02728-WANG). Research findings will be shared with hospitals and in various forms to engage broader audiences, including national and international conferences, presentations, open-access peer-reviewed journal publications, and local community workshop dissemination with healthcare professionals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: ACTRN12621000957897p https://www.anzctr.org.au/ACTRN12621000957897p.aspx.

"When the first session may be the last!": A case report of the implementation of "rapid tele-psychotherapy" with single-session music therapy in the COVID-19 outbreak.

OBJECTIVE: Conventional psychotherapy with a lengthy and regular number of meetings is no longer relevant in the case of COVID-19, when persons with psychiatric problems, especially COVID-19 patients/clients, really require immediate psychological assistance. It is recognized as a "rapid test" in the field of body health to rapidly decide whether or not a person is affected by COVID-19. So, we should now be able to use the term "rapid tele-psychotherapy" with Single-Session Music Therapy (SSMT) in the field of mental health to characterize the mechanism of assistance provided to persons who seek therapeutic assistance virtually during this COVID-19 outbreak, so that they will easily and reliably be freed from troubling psychiatric issues. METHOD: The author reports the case of a 33-year-old widow with asymptomatic COVID-19 who was admitted to her own home. RESULTS: The author describes the effectiveness of the implementation of rapid tele-psychotherapy with SSMT in reducing the scale of anxiety, panic, fear, depression, acute stress, insomnia, and delusions of death. SIGNIFICANCE OF RESULTS: This case can provide new inputs or ideas for counselors/psychologists/psychiatrists/therapists who work in hospitals/institutions to provide rapid tele-psychotherapy with SSMT as therapeutic assistance for individuals who need psychotherapy in this COVID-19 outbreak, especially for COVID-19 patients/clients. Besides that, this concept is not only suitable for rapidly screening individuals that may face psychological problems and helping them better seek therapeutic assistance, but can also be used as an adjuvant therapy for psychiatric patients.

The Effect of Mindfulness-Based Breathing and Music Therapy Practice on Nurses' Stress, Work-Related Strain, and Psychological Well-being During the COVID-19 Pandemic: A Randomized Controlled Trial.

Infectious diseases cause psychological problems for health care workers and especially nurses. Nurses who provided coronavirus disease-2019 (COVID-19) patients with care experience negative feelings such as stress, work-related strain, discomfort, and helplessness related to their high-intensity work. The aims of this study are to investigate the effect of the mindfulness-based breathing and music therapy practice on stress, work-related strain, and psychological well-being levels of nurses who provided COVID-19 patients with care. This randomized controlled trial was conducted in a COVID-19 department at a university hospital in Turkey. Nurses who care for patients infected with COVID-19 were randomly divided into an intervention group (n = 52) and a no-treatment control group (n = 52). The intervention group received mindfulness-based breathing and music therapy. In data collection, the Personal Information Form, State Anxiety Inventory, Work-Related Strain Scale, and Psychological Well-Being Scale were used. The data from the study showed that mindfulness-based breathing and music therapy decreased stress and work-related strain (P < .05) and increased psychological well-being (P < .05). The control group showed no statistically significant changes on these measures (P > .05). The mindfulness-based breathing and music therapy practice reduced nurses' stress and work-related strain and increased psychological well-being during the COVID-19 pandemic.

Students' Perception of Online Learning During COVID-19: A U.S.-Based Music Therapy Survey.

The Coronavirus disease 2019 (COVID-19) global pandemic affected music therapy education, with many university programs instantly shifting from in-person to remote online teaching. As literature related to various aspects of COVID-19 is emerging, none has yet examined music therapy students' responses to the sudden modification of teaching modalities. The aim of this study was to understand how the music therapy learning environment changed during the COVID-19 pandemic; students' experiences with unexpected remote learning, clinical training, and examination; and their perception of barriers and benefits of online learning. American Music Therapy Association students attending courses from Spring 2020 through Spring 2021 were invited to participate in this national survey. In total, 230 music therapy students across seven regions responded to the 26-item questionnaire through Qualtrics®. Seven questions were further explored with a student focus group. Results indicated that courses were mainly altered to synchronous lectures, clinical training changed to varied telepractice experiences, and examination was modified across universities. Students spent about the same time in remote learning and found synchronous lectures mostly engaging. Commonly perceived barriers included screen fatigue, physical isolation from peers, and poor internet connection. Safety during COVID-19, no traveling time, and being more comfortable at home were noted as key benefits. In conclusion, online learning allowed the continuation of music therapy education during the COVID-19 pandemic. Moving forward, the development of effective online courses and research-based guidelines for tele-interventions is desirable to improve the music therapy educational landscape during future crises and to prepare students for competent services in a digital world.

Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.

BACKGROUND: Dementia and depression are highly prevalent and comorbid conditions among older adults living in care homes and are associated with individual distress and rising societal costs. Effective, scalable, and feasible interventions are needed. Music interventions have shown promising effects, but the current evidence base is inconclusive. The present study aimed to determine the effectiveness of two different music interventions on the depressive symptoms of people with dementia living in residential aged care. METHODS: We implemented a 2 × 2 factorial cluster-randomised controlled trial to determine whether group music therapy (GMT) is more effective than no GMT with standard care, or recreational choir singing (RCS) is more effective than no RCS with standard care, for reducing depressive symptoms and other secondary outcomes in people with dementia with mild to severe depressive symptoms living in residential aged care. Care home units with at least ten residents were allocated to GMT, RCS, GMT plus RCS, or standard care, using a computer-generated list with block randomisation (block size four). The protocolised interventions were delivered by music therapists (GMT) and community musicians (RCS). The primary outcome was Montgomery-Åsberg Depression Rating Scale score at 6 months, assessed by a masked assessor and analysed on an intention-to-treat basis using linear mixed-effects models, which examined the effects of GMT versus no-GMT and RCS versus no-RCS, as well as interaction effects of GMT and RCS. We report on the Australian cohort of an international trial. This trial is registered with ClinicalTrials.gov, NCT03496675, and anzctr.org.au, ACTRN12618000156280. FINDINGS: Between June 15, 2018, and Feb 18, 2020, we approached 12 RAC facilities with 26 eligible care home units and, excluding six units who could not be enrolled due to COVID-19 lockdowns, we screened 818 residents. Between July 18, 2018, and Nov 26, 2019, 20 care home units were randomised (318 residents). Recruitment ceased on March 17, 2020, due to COVID-19. The primary endpoint, available from 20 care home units (214 residents), suggested beneficial effects of RCS (mean difference -4·25, 95% CI -7·89 to -0·62; p=0·0221) but not GMT (mean difference -0·44, -4·32 to 3·43; p=0·8224). No related serious adverse events occurred. INTERPRETATION: Our study supports implementing recreational choir singing as a clinically relevant therapeutic intervention in reducing depressive symptoms for people with dementia in the Australian care home context. FUNDING: National Health and Medical Research Council, Australia.

The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial.

BACKGROUND AND OBJECTIVES: Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants. METHODS: An open-label randomized controlled trial was conducted with participants taking anxiolytics (n = 163). Participants were randomly assigned using the Qualtrics randomizer algorithm, to a single session of sound-based treatment in one of four parallel arms: combined (music & ABS; n = 39), music-alone (n = 36), ABS-alone (n = 41), or pink noise (control; n = 47). Pre- and post-intervention somatic and cognitive state anxiety measures were collected along with trait anxiety, personality measures and musical preferences. The study was completed online using a custom application. RESULTS: Based on trait anxiety scores participants were separated into moderate and high trait anxiety sub-groups. Among participants with moderate trait anxiety, we observed reductions in somatic anxiety that were greater in combined and music-alone conditions than in the pink noise condition; and reductions in cognitive state anxiety that were greater in the combined condition than in the music-alone, ABS-alone, and pink noise conditions. While we also observed reductions in somatic and cognitive state anxiety in participants with high trait anxiety, the conditions were not well differentiated. CONCLUSIONS: Sound-based treatments are effective in reducing somatic and cognitive state anxiety. For participants with moderate trait anxiety, combined conditions were most efficacious.

Neurological music therapy during the COVID-19 outbreak: updates and future challenges.

BACKGROUND: In the last few years, several studies confirmed the effectiveness of music therapy (MT) for the rehabilitative management of patients with neurological disorders. AIM: Here we discuss the feasibility and disadvantages of tele-neurological MT (tele-NMT) compared to the traditional MT programmes. METHODS: We selected all the articles registered in the Web of Knowledge, PubMed, Google Scholar and ScienceDirect from March 2020 to November 2021 concerning tele-NMT during the COVID-19 outbreak, collecting same examples and experiences. RESULTS: With the advent of the COVID-19, several music-based interventions (MBIs) have been adapted from "in person" to a "remote and virtual" mode (through the telemedicine). DISCUSSION: Tele-NMT could represent a promising option to provide constant care and support to people with neurological diseases during the pandemic.

Effect of single session receptive music therapy on anxiety and vital parameters in hospitalized Covid-19 patients: a randomized controlled trial.

Hospitalized COVID-19 patients are vulnerable to different degrees of stress disorders as well as depression, anxiety and fear. The aim of this study was to evaluate the feasibility of introducing Music therapy on site with Covid-19 patients and investigating the immediate effects a single session has on anxiety, heart rate (HR), oxygen saturation (O2Sat) and satisfaction compared to standard care. A randomized controlled trial of 40 patients was conducted. Participants were assigned to control group (CG) or the treatment group (MG). MG received an individual single session of music therapy in presence. CG received standard care. MG and CG were subjected to identical measurements (pre-during-post) of the parameters STAI-Y, HR and O2Sat. Participants in MG were asked to fill in an optional open-ended question concerning their experience with music therapy. Significant difference in anxiety levels between scores in MG and CG (34.50 (23.25-40.00) vs 45.00(38, 25-54.00); p = 0.000) was observed. MG compared to CG had statistically significantly higher values of O2Sat (97.50 (96.25-99.00) versus 96.00 (96.00-98.00); p = 0.026). Results show the feasibility of introducing music therapy as a supporting complementary/non-pharmacological intervention on site in Covid-19 patients. A single session of music therapy improves O2Sat and can significantly reduce anxiety.Trial registration: 14/10/2021 No. NCT05077306. https://www.clinicaltrials.cov .