Psychosomatic Research Articles

Prediction of resilience based on parenting and coping strategies in patients with psychosomatic disorders.

The present research was conducted aiming at predicting the resilience based on parenting and coping strategies in patients with psychosomatic disorders. The statistical population of the present research consisted of all patients suffering from psychosomatic disorders who had visited medical clinics related to Medical Sciences (University) of Arak County in 2019-20. The statistical sample includes 347 women, aged 18 to 55 years-old, who were selected by available sampling. Data collection tool included Young parenting, Moss and Billings coping strategies questionnaire and Connor and Davidson resilience questionnaire. Pearson's correlation coefficient and multiple regression analysis were used to analyze the data. The findings showed that parenting (dependency, preoccupied/untransformed self) have a negative and significant relationship with resilience. Coping strategies focused on emotion, coping focused on physical restraint or physicalization of problems have a negative and significant relationship with resilience and have a positive and significant relationship with coping strategies focused on problem-solving and coping focused on cognitive evaluation. According to the findings, it can be concluded that it is possible to pave the way for increasing resilience and preventing the development of psychosomatic disorders by creating suitable conditions during the childhood, improving parent-child relationships, and by strengthening coping strategies focused on problem-solving and coping focused on cognitive evaluation.

Psychosomatic medicine for patients with Meniere's disease

Unpredictable attacks of vertigo with or without emesis, unilateral hearing loss, and tinnitus characterize the inner ear disorder that is classified as part of Meniere's disease (MD). While the pathological final stage with cochleovestibular hydrops seems to be certain as acomponent of MD, there are many uncertainties with respect to the multifactorial pathogenesis. It is certain that the disease can have effects in addition to the attack, which questions the treatment of things that were previously taken for granted. Persistent perceptual and postural dizziness [19] and reactive psychogenic dizziness [18] can occur, so that during the course of the disease, amixed picture of organic and psychogenic dizziness can develop. In addition, there is an increased anxiety and depression comorbidity. The course, suffering, and experience of the disease depend essentially on the processing and the active acquisition of coping strategies as well as-also the medical-treatment of the patient(s), who in their distress seek and need aknowledgeable and reliable practitioner at their side. The effects on the affected persons and suggestions for the most helpful treatment of Meniere's disease sufferers shall be described here in detail.

Comparative Effect of Aerobic and Yogic Exercises on the Selected Physical, Physiological and Academic Performance of Non-Participants of Sports at Secondary School Level

Physical activity has a direct effect on well-being and health. To be fit and healthy we need to be physically active. Regular physical activity can help protect us from serious diseases like obesity and mental illness among children. The recent study reveals that 60% of the school going children suffers obese. Physical exercise, particularly continuous aerobic exercises such as running, cycling and swimming, has many cognitive benefits and effects on the brain include increases in neurotransmitter levels, improved oxygen and nutrient delivery. The effects of exercise on memory have important implications for improving children's academic performance, maintaining mental abilities among children Riding bicycle regularly is one of the best ways to tackle the health problems associated with a sedentary lifestyle. Physical fitness and health are the integral part of human life. Fitness and wellness of person are correlated to each other. In fitness body proportion and composition are important parameters and which has roles relevance with health related fitness. Maintenance of physical fitness is needed of the day in human society. In this age of stress and tension, low level of fitness leads towards, the exposure of degenerative and psychosomatic disorders including other in effective suffering. A lot of people live with fitness myths, having their own concepts and theories of fitness and health when it comes to fitness there are many that believe strongly in the dictum 'ignorance is bliss'

Psychosomatics and the mechanisms of occurrence of psychosomatic disorder

Psychosomatics and the mechanisms of occurrence of psychosomatic disorder

Article Summaries for May 2024 Psychosomatic Medicine, Volume 86, Issue 4.

Article Summaries for May 2024 Psychosomatic Medicine, Volume 86, Issue 4.

Diagnosis and Treatment of Generalized Anxiety Disorder in Japan: Psychiatric Specialist Survey.

Generalized anxiety disorder (GAD) is a suboptimally managed chronic recurring psychiatric condition with a lifetime prevalence of 2.6% in Japan. We assessed the current status of GAD management in Japan. This was an observational, cross-sectional study conducted through an anonymous web-based survey in Japan from December 12-16, 2022. Psychiatrists and psychosomatic medicine physicians who agreed to participate and saw ≥10 outpatients in the previous month were eligible. Survey questionnaire comprised 37 single/multiple choice, numerical entry, or open-ended questions in Japanese. Among 509 participants (493 psychiatrists and 16 psychosomatic medicine physicians), 96.9% were aware of GAD. On average, 12.4 outpatients and 1.0 inpatient were diagnosed with GAD per physician per month. Of 433 physicians having patients diagnosed with GAD, 46.9% used operational diagnostic tools; among these, DSM-5 diagnostic criteria were used by 81.5% physicians. The majority (54.7%) of participants did not use a self-administered rating scale; depression scales were used more than anxiety scales. Among these 433 physicians, 96.8% used selective serotonin reuptake inhibitors for GAD management, and 79.2% used it as the first choice; of 431 physicians who prescribed drug therapy, 54.3% gave antidepressant monotherapy as first choice. The most frequent symptom in patients diagnosed with GAD was excessive anxiety/worry (96.5%); depression was the most commonly reported comorbidity (84.3%) as per physicians aware of GAD (N=508). This study illustrates that although GAD awareness is high among Japanese psychiatric specialists, GAD is not frequently diagnosed using operational diagnostic approaches. Due to a lack of Japanese guidelines for GAD diagnosis and treatment, diverse international guidelines are followed, with similar treatment paradigms as that of depression. This may not be an optimal approach given cultural/geographical differences. These findings highlight the need for uniform diagnosis and treatment recommendations for GAD management in Japan. UMIN-CTR: UMIN000049572.

Psychosomatic Disorder

Abstract: The word psychosomatics comes from the Greek word “psyche (mind) and “soma” (body) psychosomatic illness is on illness that affects the mind And body in some case mentl and emotions disorders can increases many studies have shown that chronic diseases . mouth burns etc. Psychosomatic disorder include physical and mental disorders. The physical symptoms of the diseases are caused by mental or emotional problems if often lead to stress , anixiety ,and depression when menatal disorder are not recognized ,physical pain wil occure due to hystriea although oral and paraoral patterns indicate psychosomatic disorders . The term psychosomatic diseases ,oral diseases , stress etc .relevent articles were selected and filtrated from the database using .

Applying hypnotic associative – dissociative techniques in psychotherapy for psychosomatic symptoms

ABSTRACT Patients experiencing psychosomatic symptoms frequently have difficulty obtaining correct treatment. They are often reluctant to partially attribute their symptoms to psychological factors and, as a result, delay referrals to mental health professionals. Furthermore, the dropout rate from therapy is high and relapses are common. Hypnosis is a complex psycho-physiological phenomenon. Hence, hypnotic psychotherapy may play an important role in managing and treating psychosomatic symptoms and disorders that involve both the mind and body. In the current study, we propose a clinically oriented, four-phase, hypnotic approach, the hypnotic associative-dissociative approach (HADA), which may be useful in encouraging more patients with psychosomatic problems to engage in psychotherapy, thereby achieving effective long-term effects.

Neuropsychocorrection of stress disorders

The article highlights a novel method of psychotherapy, which has a wide range of indications, including pre-nosological manifestations of emotional deficiency, depression, stress disorders of various origins and associated neurotic disorders, personality, behavioral, psychosomatic, and addictive disorders, food addiction (anorexia nervosa and bulimia), psychoactive substance dependence (alcoholism, drug addiction, substance abuse, smoking), psychological dependence in relation to individuals, as well as bad habits and any other disorders associated with psychogenic factors. We applied neuropsychocorrection as part of a complex of traditional resort treatment (study group) and observed patients in the control group who received only resort treatment. The main indicators when selecting individuals for the study were a high level of anxiety, low mood, emThe statistical data obtained as a result of the study based on the analysis of the dynamics of complaints after the course of neuropsychocorrection indicate a more pronounced stabilization of the psycho-emotional state, a decrease in emotional tension, normalization of sleep, a decrease in the level of anxiety, enhancement in interpersonal relationships, and improvement and stability of mood.otional tension, increased sensitivity to external stimuli, and somatization disorders.

The Phenomenon of Psychosomatic Disorders Among Students at Al Kamal Islamic Boarding School, Tambaksari Subdistrict, Kuwarasan District, Kebumen

Islamic boarding schools are educational institutions aimed at providing teachings and understanding of Islamic religion. The life within a boarding school differs greatly from the outside world, which can be shocking for new students. When new students enter a boarding school, they undergo a drastic transition from a free life to a life full of rules. This drastic change often causes many students to feel uncomfortable and experience stress. The stress experienced by students can lead to problems such as anxiety, inability to concentrate during lessons, and psychosomatic disorders. Psychosomatic disorders have also occurred at Al Kamal Islamic Boarding School in Tambaksari, Kuwarasan District, Kebumen. The phenomenon of psychosomatic disorders at Al Kamal Islamic Boarding School has been experienced by several students, showing symptoms such as dizziness, nausea, vomiting, and unexplained pain. These psychosomatic disorders can be addressed through relaxation programs for students at the boarding school. This relaxation program aims to provide education and socialization about psychosomatic disorders, including their causes, symptoms, and ways to overcome them. After receiving education and socialization at Al Kamal Islamic Boarding School, students have knowledge about psychosomatic disorders and how to overcome them. Students also engage in relaxation activities to prevent and minimize psychosomatic disorders.

Mode of Psychosomatic Medical Integration: Exploring the Pathogenesis of Heart, Brain-body Interaction

At present, the methods of neuroscience research have been widely used in the field of psychosomatic medical research, and now the mainstream medicine has developed a strong interest in integration, which is also a necessary prerequisite for the greater development of psychosomatic medicine. Explore multidisciplinary, multimodal, the integration of medical treatment, is expected to make patients with psychosomatic disorder treatment effect of progress, so that the causal mechanism of psychosomatic disease in new areas, compared with previous physical and mental medical research, now the neuroscience research results have stronger credibility, nerve medical research will be more psychosomatic medical research mode brings new inspiration, bring new ideas to psychosomatic disease diagnosis and treatment. Based on this, the paper proposed the integration model of mind and physical medicine, and respectively discussed the mechanism of mental and body interaction, body and body interaction, multiple and multiple interaction between mind and body, hoping to provide reference for related work.

Research progress in psychosomatic medicine in 2023: An overview

Psychosomatic medicine focuses on exploring the interactions of biological, psychological, and social factors in regulating the balance between health and disease. Recent shifts in disease spectra and medical models have contributed to the heightened prevalence and burden of psychosomatic diseases, posing new challenges to the contemporary health-care system. Consequently, there has been an imperative drive toward intensified research in psychosomatic medicine. Neuroscience methodologies have been widely applied in the research of psychosomatic diseases, facilitating the exploration of underlying causal mechanisms of psychosomatic diseases and the examination of correlations between brain function, specific organ systems, and clinical manifestations. This article offers a review of the contemporary research developments in 2023 regarding the pathogenesis, diagnosis, treatment, and intervention strategies for psychosomatic diseases, approached from various systemic perspectives. Drawing upon these insights, it offers an outlook on the future of psychosomatic medicine, aiming to enhance the integration of body–mind to clinical practice for the management of psychosomatic diseases.

Network pharmacology and experimental evidence: ERK/CREB/BDNF signaling pathway is involved in the antidepressive roles of Kaiyu Zhishen decoction

Ethnopharmacological relevanceMajor Depressive Disorder (MDD) emerges as a complex psychosomatic condition, notable for its considerable suicidality and mortality rates. Increasing evidence suggests the efficacy of Chinese herbal medicine in mitigating depression symptoms and offsetting the adverse effects associated with conventional Western therapeutics. Notably, clinical trials have revealed the adjunctive antidepressant potential of Kaiyu Zhishen Decoction (KZD) alongside Western medication. However, the standalone antidepressant efficacy of KZD and its underlying mechanisms merit in-depth investigation. Aim of the studyThis research aims to elucidate the impact of KZD on MDD and delineate its mechanistic pathways through integrated network pharmacological assessments and empirical in vitro and in vivo analyses. Materials and methodsTo ascertain the optimal antidepressant dosage and mechanism of KZD, a Chronic Unpredictable Mild Stress (CUMS)-induced depression model in mice was established to evaluate depressive behaviors. High-Performance Liquid Chromatography (HPLC) and network pharmacological approaches were employed to predict KZD's antidepressant mechanisms. Subsequently, hippocampal samples were subjected to 4D-DIA proteomic sequencing and validated through Western blot, immunofluorescence, Nissl staining, and pathway antagonist applications. Additionally, cortisol-stimulated PC12 cells were utilized to simulate neuronal damage, analyzing protein and mRNA levels of MAPK-related signals and cell proliferation markers. ResultsThe integration of network pharmacology and HPLC identified kaempferol and quercetin as KZD's principal active compounds for MDD treatment. Proteomic and network pharmacological KEGG pathway analyses indicated the MAPK signaling pathway as a critical regulatory mechanism for KZD's therapeutic effect on MDD. KZD was observed to mitigate CUMS-induced upregulation of p-ERK/ERK, CREB, and BDNF protein expressions in hippocampal cells by attenuating oxidative stress, thereby ameliorating neuronal damage and exerting antidepressant effects. The administration of PD98059 counteracted KZD's improvements in depression-like behaviors and downregulated p-ERK/ERK and BDNF protein expressions in the hippocampus. ConclusionsThis investigation corroborates KZD's pivotal, dose-dependent role in antidepressant activity. Both in vivo and in vitro experiments demonstrate KZD's capacity to modulate the ERK-CREB-BDNF signaling pathway by diminishing ROS expression induced by oxidative stress, enhancing neuronal repair, and thus, manifesting antidepressant properties. Accordingly, KZD represents a promising herbal candidate for further antidepressant research.

Follow-up outpatient clinics for patients with post COVID: a survey to assess and characterize aspects of care

After acute infection with the SARS-CoV-2 virus, up to 10 % of affected individuals suffer from long-term health impairments, also referred to as "Post-COVID". In Germany, specialized outpatient clinics have been established to care for patients with Post-COVID. A structured survey of the care situation is not yet available, but essential for a demand-oriented care. The present study aimed to systematically assess and describe structural and process-related aspects of care, and to perform an inventory and needs analysis of Post-COVID outpatient clinics in Germany.An online survey was developed assessing the structure and organization of the outpatient clinics, service offerings and networking of care from the perspective of the outpatient clinic directors. A total of 95 outpatient clinics were identified, and an invitation to participate in the online survey was sent via e-mail to the directors of the outpatient clinics. Data were collected between February and May 2022. Descriptive data analysis was performed.A total of 28 outpatient clinic managers (29 %) took part in the survey. Participants were between 32 and 66 years old, and 61 % (n = 17) were male. The outpatient clinics were most frequently affiliated with the specialties of pneumology (n = 10; 36 %), internal medicine, psychiatric and psychosomatic medicine, and neurology (n = 8; 29 %, respectively). Among the outpatient clinic directors, 64 % (n = 18) stated that the time spent waiting for an appointment was more than one month. Utilization (n = 25; 89 %), appointment demand (n = 26; 93 %), and the need for more Post-COVID outpatient clinics (n = 20; 71 %) were rated as high by the outpatient clinic directors. Nearly all directors reported networking with in-clinic facilities (n = 27; 96 %), with primary care physicians and with specialists in private practice (n = 21; 75 %, respectively).The main focus of care is pneumology. Internal medicine, psychiatry/psychosomatics and neurology are also equally represented. Our data further suggest a high demand for Post-COVID outpatient clinics and the need to expand this care offer.

Article Summaries for April 2024 Psychosomatic Medicine, Volume 86, Issue 3.

Article Summaries for April 2024 Psychosomatic Medicine, Volume 86, Issue 3.

Manas (Mind) Structure: Exposing the Mysterious Functional Anatomy in the Indian System of Medical Philosophy

The mind is not structured anatomically, as emphasized by modern pathology. Instead, it is expanded as a whole in a subtle form behind the physical body. In the Indian system of medical philosophy, the mind is considered as the astral nerves made third body, which identified as the ‘Manomaya-sharira’ (subconscious mind). The mind is composed of millions of astralnadis, through which Pranic-energies circulate freely into the astral anatomy of mind. Seven-chakras are found parallel to the spine, serving as the major seven innovation centres in the body. These Chakras facilitate the connection of the mind with the seven dimensions of the inner world. From these dimensions the Pranic-energies including Sattva, Raja, Tama are exported to the mind and its Nadi-tantras, influencing both the outer and inner subconscious minds. Subsequently, these elements, viz., Sattva, Raja and Tama are thrown from the mind to the outer world through the seven sense organs, manifesting as either constructive or destructive activities. Thus the mind exists due to ‘Prana’, (energy of Omkara) which increases through deeper meditation, sound sleep, and breathing exercises (O2). The positional behaviour of the mind shifts according to the physical and mental temperament, namely Triguna and Tridosha, or Panchavikara. The negative energy (Tama-guna) of the fourth dimension enters the astral Nadis-system of the mind via the interspace of the solar plexus, which crushes the mind’s structures, and consequently, all the Chakras are corrupted and the Nadis are blocked, so it generates a break in the circulation of ‘Prana’ into the Nadis. As a result, many socio-economic challenges and psychosomatic disorders occur.

Allostatic overload in the medically ill patients: Results from an observational study

The present study aimed at evaluating the prevalence of allostatic overload (AO) among subjects with different medical diseases and explore whether medically ill patients with or without AO differ for specific clinical features (i.e., co-occurring mental or psychosomatic disorders). An observational cross-sectional study was carried out. Outpatients with a diagnosis of blood cancer, systemic sclerosis, or migraine received a clinical assessment which included the Mini International Neuropsychiatric Interview or the Structured Clinical Interview for DSM-5 and the Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview (DCPR-R SSI). Four hundred and thirty-nine outpatients were enrolled. Among them, 39 (8.9%) had a diagnosis of blood cancer, 200 (45.5%) had a diagnosis of systemic sclerosis, and 200 (45.5%) had a diagnosis of migraine. A total of 104 (23.7%) patients had a DCPR-R diagnosis of AO. Patients with a diagnosis of blood cancer, migraine, or systemic sclerosis did not differ for DCPR-R AO prevalence (P = 0.082). Based on multiple regression analysis, medically ill patients with DCPR-R AO were more likely to satisfy the diagnosis of DCPR-R illness denial (odds ratio [OR] = 2.99, 95% confidence interval [CI] = 1.04 – 8.58), conversion symptoms (OR = 5.32, 95% CI = 1.16 – 24.38), or demoralization (OR = 2.57, 95% CI = 1.08 – 6.11) and a DSM-5 diagnosis of major depressive episode/disorder (OR = 1.90, 95% CI = 1.03 – 3.50), if compared to those without DCPR-R AO. DCPR-R AO is a clinically useful transdiagnostic feature potentially associated with other psychosomatic syndromes and mental disorders that may contribute to the disease burden and the poor global health conditions of medically ill patients.

Music therapy in eating disorder treatment and its synergy with systemic and family-based therapy approaches: A systematic review

Eating disorders are serious psychosomatic disorders and constitute the most common chronic disorder of female adolescence. Men experience a later onset but appear to constitute around 25% of adult cases. Due to their comorbidities and high mortality rate, these conditions pose a significant health risk. Although systemic and family therapy are considered among the most successful treatment modalities in adolescence, there is a need for expanded treatment options. With this background, the question arises as to what extent music therapy is already integrated into treatments. This review aims to include studies on music, music therapy, and eating disorders in general and covering all age groups. In all, 26 studies met the criteria for review, with a total of 1026 participants. None of the studies used music therapy combined with systemic or family-based therapy. However, despite differences between study designs, the individual studies show commonalities in their interventions and a relationship to the systemic and family-based approach. This review suggests that music therapy may be a valuable complement to the treatment modalities of systemic and family-based therapies as well as to constellations and sculpture approaches in eating disorders treatment. Further research is recommended to evaluate the effectiveness of such combined approaches.

ELECTROMYOGRAPHY AS A METHOD FOR ASSESSING THE EFFECTIVENESS OF ORTHOPEDIC TREATMENT OF PATHOLOGICAL ABRASION OF HARD TISSUES OF TEETH

The combination of pathological wear of the teeth with defects of the dental rows causes significant changes in the maxillofacial complex, which leads to substantial morphofunctional disorders and creates difficulties in the orthopedic rehabilitation of such patients.
 The combination of pathological tooth wear and defects of the dental rows causes significant changes in the maxillofacial complex, which leads to substantial morphofunctional disorders and creates difficulties in the orthopedic rehabilitation of such patients.
 Thirty four persons aged from 35 to 60 years with a generalized form of pathological wear of grades I-II, in combination with defects of dentition of classes I, II and III according to Kennedy, were treated. The examination has included the data of the anamnesis, general clinical examination, measuring interalveolar height, study of diagnostic models, X-ray examination, and EMG of the masticatory muscles.
 The results. The EMG data of the research groups before treatment showed a different degree of the rhythm of chewing movements, a clear alternation of the phases of activity and rest, uneven inclusion of motor units in the contraction process compared to healthy patients, the habitual side of chewing was determined, as a result of which an extension of chewing time, a decrease in its rhythm and chewing efficiency.
 Thirty days after the appropriate treatment, the electromyographic study showed morphological and functional changes in the maxillofacial apparatus of the patients of the experimental groups, which were reflected in the quantitative indicators of the EMG of the masticatory muscles. In the I group, the EMG parameters significantly approached those in the control group, and in the II group, a tendency to approach the norm was determined.
 Appropriate orthopedic treatment of pathological attrition, complicated by existing dentition defects, various structures contributed to the emergence of new myotatic reflexes, the creation of a new chewing stereotype.
 A positive change in EMG indicators, especially the "K" coefficient, and their approach to the indicators of the control group indicates the appropriate choice of the prosthetic method, which will contribute to the process of adaptation to the orthopedic structure and improve the psycho-somatic condition of patients in general.
 Conclusions. Analyzing the variance in biopotentials of the masticatory muscles enables the evaluation of both the extent and the characteristics of existing disorders in patients with pathological attrition.
 The positive dynamics of electromyography indicators in the treatment of patients with a generalized form of pathological wear, complicated by defects of the dental rows, indicates the quality of the treatment, the feasibility of choosing an orthopedic structure, and the smoothness of the process of adaptation to it.
 The future research involves continued monitoring of long-term treatment outcomes, including the potential for determining the duration required for complete adaptation to the orthopedic prosthesis.

Daoyin therapy in chronic neck pain: study protocol for a randomized controlled trial

BackgroundDaoyin therapy (DT), an ancient therapeutic approach with a history spanning thousands of years, has traditionally been employed to address musculoskeletal pain and psychosomatic disorders. However, the application of DT for chronic neck pain (CNP) has received limited attention in the existing literature, and systematic randomized clinical trials (RCTs) in this context remain scarce. This manuscript outlines an RCT protocol designed to investigate whether DT is more effective at alleviating CNP in adult individuals compared to other interventions.MethodsA 12-week RCT was conducted, with participants undergoing randomization into one of three groups: DT, Meditation + Fitness Exercise (M+FE), or a control group. Participants in the DT and M + FE groups attended their respective training classes three times per week for 12 weeks. Participants in the control group were required to attend health education workshops every 2 weeks. Following the 12-week intervention period, all participants underwent follow-up assessments at the 16th week. Outcome measures encompassed the Simplified Chinese Neck Pain and Disability Scale (SC-NPAD) and Visual Analog Scale (VAS) for pain assessment, Static Neck Posture Assessment (SNPA) to evaluate neck and shoulder posture and function, Short Form-36 (SF-36) to assess quality of life, and blood tests measuring 5-Hydroxytryptamine (5-HT), Norepinephrine/Noradrenaline (NE/NA), γ-aminobutyric acid (GABA), Adreno-Cortico-Tropic-Hormone (ACTH), β-Endorphin (β-EP), and Calcitonin-Gene-Related Peptide (CGRP) levels via high-performance liquid chromatography (HPLC), chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), and radioimmunoassay (RIA). Brain activity changes were monitored through MRI scans. Repeated measures analyses of variance (ANOVAs) will be used to evaluate the outcomes at baseline, at the 12th week, and at the 16th week. Generalized Estimating Equation (GEE) models will be applied to analyze changes in outcomes over time and differences between groups.DiscussionThis trial aims to evaluate the efficacy of DT in comparison to other interventions and explore the neuroendocrine mechanisms underlying its effects in adults with CNP. If the intervention and procedures demonstrate feasibility and acceptability, there are plans to conduct a more extensive controlled trial. This could potentially pave the way for the broader application of DT, not only in the context of CNP but also for other chronic diseases.Trial registrationThis trial has been registered with the Chinese Clinical Trial Registry (Registration ID: [ChiCTR2400079571]).