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Anxiety Disorders clinical trials

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NCT ID: NCT06192225 Recruiting - Anxiety Clinical Trials

Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients

SlowPACE
Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The purpose of this single-center trial is to examine the effects of a slow-breathing technique performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S),13 compared to usual care.

NCT ID: NCT06191783 Recruiting - Anxiety Clinical Trials

The Effect Of Preoperative Anxiety Level On Postoperative SoreThroat

Start date: February 2, 2023
Phase:
Study type: Observational

Tympanoplasty is the general name given to operations in which the defect in the tympanic membrane is repaired with a connective tissue graft to correct the pathology in chronic otitis media and its sequelae. The pathology in the middle ear and mastoid system may vary from a central tympanic membrane perforation in which the mucosa and ossicles in the middle ear are completely dry to cholesteatoma in which the entire membrane and ossicles in the middle ear are destroyed and sometimes complications such as facial paralysis, labyrinth fistula, meningitis and brain abscess are observed. A simple myringoplasty in which only the perforated eardrum is repaired is the simplest type of tympanoplasty. A radical masteidectomy is a procedure in which the middle ear and the outer ear mastoid system are moulded into a single cavity. Anxiety is an emotional state defined as a restless feeling whose source is usually uncertain. It may cause abnormal haemodynamic changes as a result of sympathetic, parasympathetic and endocrine stimulation. Patients' anxiety and fear increase during the time they are waiting for the operation. Elimination of anxiety in the preoperative preparation period is important to improve the quality of postoperative recovery and reduce costs (4). Scales such as State-Trait Anxiety Inventory (STAI: State-Trait Anxiety Inventory), APAIS, Hospital Depression and Anxiety Scale (HADS), and Beck Anxiety Scale (Beck Anxiety Scale), which measure trait and state anxiety separately, can be used to determine anxiety levels. Postoperative sore throat (POST) is a common complication of general anesthesia. Although it is less harmful than other complications, it decreases postoperative comfort of patients and may prolong hospital stay. After intubation, patients may experience complications such as hoarseness, dysphagia, cough and dry throat with POST. The incidence related to tracheal intubation has been reported to be 62% and it is thought to be caused by injury with laryngoscopy or damage to the tracheal mucosa due to cuff pressure. Sore throat in the postoperative period negatively affects patient comfort and may lead to an unpleasant anesthetic experience. This study aimed to reveal the relationship between preoperative anxiety level and postoperative sore throat and other complications in patients undergoing tympanoplasty.

NCT ID: NCT06190964 Recruiting - Anxiety Clinical Trials

Integrative Medicine for Hospital Workers Exposed to War

Start date: October 21, 2023
Phase: N/A
Study type: Interventional

During the "Iron Swords" war in Israel in 2023, the residents of the Gaza Strip and the surrounding area, along with the soldiers of the security service, were exposed to a very high intensity of trauma. Added to this is an extensive cycle of trauma for those who were directly and indirectly exposed to loss and terror throughout the country. Medical teams in the hospitals and in the community were exposed with the highest intensity to these traumatic aspects which were amplified by the collapse of many of the resilience and mental health centers in the south. An integrative medicine treatment clinic was established at the Bnai Zion Medical Center for the purpose of providing a response to all hospital employees who are exposed and will be exposed (directly or indirectly) to the wounded and patients expressing trauma, including symptoms of acute stress disorder, as a result of war and terrorism. Hospital employees are invited to register for complementary medicine treatments on the hospital's website according to indications that include anxiety, emotional distress and/or typical Acute Stress Disorder (ASD) symptoms, including physical distress (such as pain, breathing disorder, digestive system symptoms, exhaustion, etc.). The employees are treated by a team from the system for integrative medicine, including practitioners of acupuncture; touch/movement techniques (for example, qigong, reflexology, shiatsu) or mind-body medicine (for example, relaxation and breathing exercises) and may include one or more of the above 3 treatment areas. In the proposed study, the investigators plan to examine the effect of these treatments on various symptoms experienced by hospital employees during this period.

NCT ID: NCT06190184 Recruiting - Depression Clinical Trials

Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Start date: October 26, 2023
Phase: N/A
Study type: Interventional

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

NCT ID: NCT06188962 Recruiting - Depression Clinical Trials

Evaluating Knowledge Insight Tools (KIT) for Reducing Anxiety and Low Mood in UK Secondary School Students

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Background and Study Aims: Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support. Who can participate? Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services. What does the study involve? The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment. What are the possible benefits and risks of participating? The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time. Where is the study run from? The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be. When is the study starting and how long is it expected to run for? The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed. Who is funding the study? The study is funded by Place2Be and Anna Freud, both UK-based charities. Who is the main contact? The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).

NCT ID: NCT06185049 Recruiting - Clinical trials for Risk Factors (Rejection, Bullying/Cyberbullying, Addictions, Healthy Lifestyle Habits, Exam Stress Management, Ecoanxiety, Expressed Emotion)

Selective Prevention Transdiagnostic Intervention for At-risk Adolescents With Booster Sessions. (PROCARE+ 2.0)

Start date: March 23, 2023
Phase: N/A
Study type: Interventional

Emotional disorders such as anxiety and depression are significantly underdiagnosed and undertreated, even though they are some of the most prevalent mental health conditions, especially among young individuals. Approximately 50% of mental health disorders manifest by the age of 14, and around 75% appear by the age of 24, underscoring the critical importance of addressing these issues during adolescence. Unfortunately, during this developmental stage, early warning signs and even fully developed clinical conditions often go unnoticed, undiagnosed, and untreated. Nonetheless, there is a lack of established, evidence-backed procedures aimed at reaching out to adolescents at risk of developing emotional disorders. Urgently required is a fundamental shift in our approach by creating intervention protocols that allow for the early identification and treatment of at-risk adolescents, thus averting the potential development of severe mental health disorders as they mature. The selective prevention of mental health issues is a crucial element in assisting at-risk adolescents in flourishing before emotional disorders progress. To address this gap, PROCARE+ was conceived as a modularized selective prevention program for adolescents aged 12 to 18 years. Using a personalized medicine approach, PROCARE+ successfully allowed for the adaptation of intervention protocols according to the specific needs of each individual, while also identifying vulnerable individuals based on risk factors. PROCARE 2.0 aims to enhance the PROCARE+ intervention by maximizing and extending its effects beyond the population in the post-COVID-19 pandemic era. PROCARE 2.0 stratifies adolescents based on their risk and resilience status and will deliver, alongside a core intervention, new specific add-on modules designed to address risk factors identified by adolescents: : 1) Situations of rejection, bullying, and cyberbullying; 2) Addiction to new technologies such as video games or mobile phones and other substances like alcohol, tobacco, and drugs; 3) Improvement of healthy lifestyle habits related to nutrition, sleep, and physical activity; 4) Enhancement of stress-related situations: Ecoanxiety or exam-related anxiety; and 5) Improvement of parent-child relationships and situations of high expressed emotion (parent module). Furthermore, emphasis will be placed on the study of reinforcement sessions to maintain the results following the initial intervention (based on central and additional modules depending on the detected risk factors). Adolescents will be assigned to different experimental groups with or without reinforcement sessions in order to increase the effectiveness of the intervention. PROCARE 2.0, like PROCARE, aims to reduce the impact of risk factors and enhance protective factors that will ultimately lead to lasting positive effects for adolescents. It will combine quantitative analyses, with a special focus on vulnerable groups in a disaggregated approach by sex, gender, sexual orientation, and socioeconomic status. The PROCARE 2.0 project is expected to have a significant impact. Its outcomes will continue to contribute to the identification and preventive treatment of adolescents at risk of emotional mental disorders at an early stage, before they incur personal, social, and economic costs.It will be designed to be an acceptable, scalable, and sustainable selective prevention program, striving to increase its effectiveness beyond the context of the COVID-19 pandemic, ultimately contributing to the prevention and reduction of the prevalence of mental disorders in young people.

NCT ID: NCT06183333 Recruiting - Depression Clinical Trials

Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks. The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.

NCT ID: NCT06182787 Recruiting - Schizophrenia Clinical Trials

Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient

Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

This study presents the development and validation of a unique Digital Experience Sampling Method (ESM) questionnaire specifically adapted for monitoring changes in the mental state of patients during psychiatric hospitalization. The questionnaire was carefully crafted through focus groups involving patients and clinical staff, ensuring its relevance and applicability to the unique characteristics of mental state changes in a hospitalization setting. To evaluate the validity of the ESM questionnaire, symptom severity trends obtained from the questionnaire will be compared with estimates derived from the Positive and Negative Syndrome Scale (PANSS) assessment. Data will be collected from 100 subjects over a 14-day psychiatric hospitalization period. In addition to the ESM questionnaire, smartwatch sensors will monitor physiological indicators. Feasibility and patient compliance will be assessed by examining patients' willingness to use the digital ESM questionnaires and the smartwatch sensors. The study will also cross-reference self-reported sleep quality and activity levels captured in the ESM questionnaires with objective physiological indicators and nursing staff reports, providing insights into the reliability of the patient-reported data. Furthermore, the study will evaluate the impact of the ESM data on clinical decision-making by physicians throughout the 14-day psychiatric hospitalization period. Patient satisfaction and satisfaction among the multidisciplinary team with the monitoring model will also be assessed. This research underscores the potential of digital technologies to enhance patient-centered care and facilitate informed treatment decisions in psychiatric hospitalization settings.

NCT ID: NCT06182462 Recruiting - Dental Anxiety Clinical Trials

Virtual Reality Distraction for Dental Anxiety (RCT)

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures. The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments. Main research question: Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures? Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play, facilitating the dental procedure. The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker (alpha-amylase).

NCT ID: NCT06176924 Recruiting - Anxiety Clinical Trials

Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Anxiety is one of the most significant obstacles to academic success. When stress is interpreted negatively or becomes overwhelming, it causes anxiety before and during examinations, which in turn impacts students' academic performance. The difficulty in managing severely associated anxiousness enhances the demand for NIBS. It is a unique approach that has the potential to alleviate anxiety by modifying cortical excitability whereas Relaxation breaks the vicious cycle of pain caused by muscular stress, circulatory illness, and metabolic by-products alterations. The main purpose is to evaluate whether tDCS along with Relaxation technique reduces the anxiety level in competitive exam students. Total 46 students are recruited and randomly allocating in experimental and control group. The subjects in the experimental group are going to receive 9 tDCS sessions (2mA, anode placed on the DLFPC of left side and cathode on right supraorbital cortex for 20 min) along with relaxation technique. Subjects in the control group are going to receive 9 sessions of relaxation. The CSAI-2R scale is used as an Outcome Measure. Samples completed the CSAI-2R scale before and following the intervention. The data will be analyzed using SPSS 26.0 software.