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Anxiety State clinical trials

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NCT ID: NCT06420232 Recruiting - Anxiety State Clinical Trials

Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population

Food Anxiety
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

This small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating.

NCT ID: NCT06341569 Recruiting - Motivation Clinical Trials

Physical Therapy Students: Well-being

Start date: May 9, 2024
Phase: N/A
Study type: Interventional

This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students.

NCT ID: NCT06221436 Recruiting - Anxiety State Clinical Trials

The Effect of Olfactory Mental Imagery and Cardiovascular Surgery

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery. This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study. Patient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform breathing exercises with the olfactory mental imagery technique.

NCT ID: NCT06215456 Recruiting - Anxiety Clinical Trials

Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography

VR InCard
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography. Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.

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: NCT06187090 Recruiting - Clinical trials for Autism Spectrum Disorder

The Supplementation Therapy in Autism and Response to Treatment Study

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

In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks. During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting. The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.

NCT ID: NCT06034496 Recruiting - Anxiety State Clinical Trials

Cranial Electrotherapy Stimulation and Acute Stress

Start date: September 12, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to quantify the effects of 20 sessions of Cranial Electrotherapy Stimulation (CES) on measures of acute stress responses in Soldiers. The main question it aims to answer is how 20 sessions of CES will affect Soldiers' biochemical (salivary alpha amylase and cortisol), physiological (e.g., heart rate, heart rate variability, respiration rate), emotional (state anxiety), and behavioral (i.e., cognitive task performance) responses. - On Day 1, participants will complete a baseline measure assessing their biochemical, physiological, emotional, and behavioral responses to a stressful lethal force decision making task. - In the next four to six weeks, participants will complete 20 CES sessions. - Within five days of completing the 20 CES sessions, participants will complete a follow-up measure assessing their biochemical, physiological, emotional, and behavioral responses to the same stressful lethal force decision making task they completed on Day 1. Researchers will compare the Active CES group to the Sham CES group to see how 20 sessions of Active CES will affect the participants responses to their biochemical, physiological, emotional and behavioral responses relative to the Sham CES group.

NCT ID: NCT06030921 Recruiting - Anxiety State Clinical Trials

Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.

Start date: February 1, 2023
Phase:
Study type: Observational

Previous studies have accepted a strong correlation between anxiety and dysregulation in respiratory rate. The investigators would like to explore this correlation from an osteopathic perspective. The investigators seek to assess the muscles, bones, ligaments, and fascia related to the respiratory system, mainly the thoracic diaphragm. The study does not focus on clinically diagnosed General Anxiety Disorder but rather State-Trait Anxiety among medical student participants. State Anxiety is the temporary anxiety one feels in certain situations, and Trait Anxiety is the stable tendency to become anxious. The investigators aim to assess somatic dysfunctions in medical students' respiratory systems and correlate those findings with their respective scores on the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) survey. The investigators will assess the patient's somatic dysfunction using an osteopathic structural exam, and the STICSA will quantify the patient's level of statetrait anxiety. This inquiry will further explore osteopathic medicine's perspective on addressing the patient as a whole by correlating the close relationship between one's mental state and the resultant physical dysfunctions within different areas of the body. Establishing this correlation can pave the way for a new perspective on treating mental health disorders that is both cost-effective and potentially more efficacious than the traditional method, which has a high relapse rate. Exploring the connection between somatic dysfunctions and state-trait anxiety will benefit the patient's overall well-being and add a new level of care that osteopathic physicians can provide to others.

NCT ID: NCT05956249 Recruiting - Depressive Symptoms Clinical Trials

Online Group Therapy for Mothers of Babies With Congenital Heart Disease

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

Introduction: Mothers of babies with congenital heart disease tend to have higher levels of depression, stress and anxiety. Currently, psychological support group technology has been a resource increasingly used by health professionals, with a therapeutic objective as an instrument to promote care. Objective: The aim of this study is to evaluate the effectiveness of a group intervention in improving depression, anxiety and the psychological well-being of mothers of babies with congenital heart disease. Methods: Randomized, parallel clinical trial, in which the factor under study will be online group therapy and the outcome the level of depressive symptoms, anxiety and psychological well-being, assessed using the instruments: BECK-II, BAI and Wellness Scale Ryff's psychological well-being at the beginning and after the intervention. The fellow who will reapply the instruments will be blinded to the groups. Patients will be randomized 1:1, with odd numbers assigned to treatment (online group therapy) and even numbers assigned to controls (no online group therapy). The intervention group will have 8 weekly group consultations, psychoeducational and focused on depression, anxiety and psychological well-being. The sample size was calculated at 36 individuals for each group. Data will be analyzed using the statistical program Statistical Package for Social Sciences (SPSS) version 27.0. For comparison between groups, Student's t test or Kruskall-Wallis or Chi-square test will be used. A two-tailed value of p≤ 0.05 will be considered significant. The normality of instrument scores will be evaluated using the Kolmogorov-Smirnov test. Covariance analysis will be performed to assess the influence of initial scores of anxiety, depression and well-being and their changes after intervention. The effect size will also be calculated. Expected results: It is expected to know and describe the population studied with regard to the level of depressive symptoms, anxiety and psychological well-being. In addition to seeking knowledge about the effectiveness of Group Therapy for these variables.

NCT ID: NCT05932095 Recruiting - Anxiety State Clinical Trials

TCM Daoyin in the Treatment of Patients With Anxiety State

Start date: June 13, 2023
Phase: N/A
Study type: Interventional

In recent years, the number of people with symptoms of anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM Daoyin intervention. Thus, the aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.