View clinical trials related to Anxiety Disorders.
Filter by:Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for an MRI. Objectives: The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to address the feasibility and acceptability of the use of virtual reality. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CHU Sainte-Justine's, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics, measures of anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Discussion: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.
Aim of the study: Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.
Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of anxiety, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. It also could present an alternative intervention for patients who are non-responsive or refuse medication. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with anxiety.
Transdiagnostic approaches have been proposed as more truthfully representing mental health problems. Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach that proposes Psychological Inflexibility/Flexibility (PI/PF) as the root of human suffering/flourishing. ACT has been recognized as conceptually and clinically relevant for adult disorders. However, during adolescence, when anxiety disorders are highly prevalent, the same evidence is scarce. Specifically, methodologically robust designs investigating ACT's efficacy on adolescents' ADs are scarce and mechanisms underlying change during ACT for adolescents with ADs have not been investigated. Therefore, this study aims to adapt, implement, and investigate the efficacy of an online delivered (through videoconference) ACT intervention to adolescents presenting SAD or GAD, thus contributing to amplifying the transdiagnostic application of ACT to these disorders. A Randomized Controlled Trial (RCT) with 3 groups (i.e., Control, GAD intervention, and SAD intervention groups) of adolescents aged between 14 and 18 years old will be conducted. Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3- and 6-month follow-ups. The investigators expect improvements in outcome variables (e.g., anxiety symptoms) at post-treatment for intervention groups. When comparing changes in outcome variables between the control and the intervention groups, improvements are expected only in the groups receiving intervention. Additionally, similar effects on outcome measures are expected in both intervention groups with gains being maintained over time (i.e., at 3- and 6-months follow-up). Finally, changes in PI/PF processes are expected to predict changes in outcome variables in both intervention groups. This RCT will provide valuable insights that can potentially enhance the efficacy of treatment modalities, contributing to improved well-being for adolescents with ADs.
Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.
Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels. Objective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety. Methods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure. Expected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected.
Virtual Reality (VR) applications, one of the commonly emphasized approaches in the medical field recently, is in place as an intervention method applicable in various fileds of medicine for distraction, experiencing being exposed to events creating stress and palliating anxiety through providing materials which may distract the patient's attention from a stressful condition. The study has been planned in order to evaluate the effect of the notification regarding the theatre environment through virtual reality to the patients, who are to go through abdominal surgical intervention, on the anxiety level and the vital signs during the surgical intervention. Being a non-pharmacological clinical randomize controlled one, the study shall be conducted in Dr. Burhan Nalbantoğlu State Hospital of TRNC Ministry of Health surgical service and preoperative waiting area. Sample number has been determined through power analysis using G*Power 3.1.9.2 software. Taking (2017) "The effect of virtual reality in reducing preoperative anxiety in patients prior to arthroscopic knee surgery: A randomised controlled trial" study of Robertson and friends as the reference, the effect size, regarding the anxiety scores of experiment and control groups participants, has been determined as 0,63. Accordingly, sample size has been calculated as 71 people necessary for 95% (1-β=0,95) power at d=0,63 and α=0,05 levels. Taking into account there may be losses during the study, it has been planned to involve 80 people, so as to have 40 people per each group, in the study. Since the patients, who are to be involved in the study, are not known; in order to assign same quantity of patients to each group prior to the study, randomization shall be done through using block randomization technique in GraphPad software so as to have 40 patients in the intervention group and 40 in the control group. The patients who receive standard clinical care prior to abdominal surgical intervention shall constitute the control group, the patients who receive information about operating room environment through VR goggles in addition to standard clinical care shall constitute the intervention group. The data shall be collected through "Individual characteristics Form", ''Patient Charts'', ''Surgical Anxiety Scale'', ''Galvanic Skin Sensor (GSS) Measurement Table''. SPSS 26 Statistical analysis program shall be used for evaluating the study data. The acquired data shall be tested at 95% confidence interval, p<0,05 level of significance. Number, percentage distributon and standard deviation for the definitive data analysis, chi square test for experiment and control groups' basic particulars similarity, Shapiro-Wilk for normality analysis of dependent variables, Student t test or Annova for the comparison of pre-test and final test scores of experiment control groups, the comparisons of variables giving normal distribution among the groups as per the normal distributon in the comparison of experiment control groups' pre-test and final test scores, Mann Whitney U test or Kruskal Wallis test for the variables of non-normal distribution shall be used.
The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia: 1. Pain perception. 2. Pain related behaviors. 3. Dental anxiety 4. Anesthetic efficiency. 5. Patient acceptance and preference
Introduction. Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely. Virtual reality use could improve DFA in children with special health care needs (SHCN) undergoing dental procedures. Aim. Assess the feasibility and acceptability of VR immersion as a tool to reduce dental fear and anxiety in pediatric special needs patients undergoing dental procedures and gain insight on parents and healthcare providers perspectives on the use of VR during dental appointments. Methods. This pilot randomized controlled trial study will follow a parallel design including two groups: A control group (clinic's standard care) and an experimental group (virtual reality). Twenty participants will be randomized to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The experimental group will receive the VR video game Dream designed specifically for this study. It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. The primary outcome will be assessment of dental fear and anxiety in children using both observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale (VABRS) and a physiological biomarker such as the level of salivary alpha-amylase. Sociodemographic characteristics, measures of level of satisfaction of parents and healthcare professionals, occurrence of side effects and any deviation from normal procedure length will also be collected. Analysis will be carried out using statistical analysis software SAS (version 9.4; Cary, NC, USA). Descriptive statistics will be conducted for demographic and clinical variables and will be used to present parents and healthcare professionals' satisfaction levels, and also procedural time. Discussion. The investigators believe that the results of this pilot study will provide a better understanding of the feasibility and effect of VR on DFA in children with SHCN.
Sexual minority stressors (e.g., sexual minority identity-based discrimination) contribute to greater risk for and severity of depression, anxiety, substance use disorders and suicide among sexual minority Veterans. However, no brief, scalable, one-on-one interventions targeting sexual minority stressor-related distress are available in Veterans Affairs (VA) for sexual minority Veterans. The proposed research will examine the feasibility, acceptability, and preliminary effectiveness of a brief, 3-session expressive writing intervention to target distress related to sexual minority stressor exposure among sexual minority Veterans. The results of this work will advance knowledge about a promising brief and easy to implement intervention focused on reducing depressive and anxiety symptoms among sexual minority Veterans. This proposal aligns with VA's and CSR&D's commitment to providing equitable services to sexual minority Veterans and the aim of reducing health disparities among underserved Veteran groups.