Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry
Dental AnxietyDental Pain1 moreDental pain and anxiety are usually managed by local anesthetics and sedatives, but patient anxiety and fear of pain remain common and adversely affect oral health behavior and outcomes. The long-term goal is to provide a validated behavioral alternative/adjunct for managing dental anxiety and pain through a commercial Comfort Talk® (Cft) app. Such an application should benefit the patients undergoing the >300 million dental procedures per year in the US alone. In Phase I (Clinical Trials Identifier NCT03328208), the investigators designed such an app based on short Comfort Talk® scripts and snippets that, when spoken live by trained personnel in our prior large-scale clinical trials, reduced pain, anxiety, and drug use during invasive procedures, and when used practice-wide, improved patient attendance, throughput, and economics. In Phase I, the Cft app significantly reduced pain and anxiety in the dental waiting room. In Phase II, the investigators propose to further assess its impact. We hypothesize that: The Cft app reduces pain and anxiety in the waiting room The Cft app improves the patient experience and cooperation during dental treatment The Cft app improves operations and economics of dental practices Heart rate tracings are helpful in identifying outcome-critical app elements 150 patients scheduled for root canals or dental implants will receive in randomized sequence the Cft app or a placebo white noise app in the dentistry waiting room of Cambridge Health Alliance. Anxiety and pain will be measured subjectively on validated scales (0-no anxiety/no pain at all; 10-worst anxiety/pain possible) before listening and throughout the visit. Heart rate (HR) and ECG will be continuously recorded to assess adverse events and, in the absence of a validated biomarker for pain and anxiety, serve as an exploratory physiologic indicator of distress. Usage patterns of the Cft and the placebo apps will be established electronically through time-stamped background capture, de-identified, and uploaded to a database along with the corresponding HR recordings and overlayed with the patient's subjective ratings and procedure steps to identify outcome-critical elements of the app. We will record chair-time, staff-time, use of anesthetics and sedatives, if applicable, and patient and staff satisfaction, supplemented by bulk data acquired from other practices that use a co-branded version of the app, to determine the economic impact of the Cft app.
FASTMAS (Fast-Fail Trials in Mood and Anxiety Spectrum Disorders) Kappa Opioid Receptor Phase 1...
Anxiety DisordersThe available treatments for patients with mood and anxiety spectrum disorders have significant limitations. This study will contribute significantly to public health by taking steps to address these limitations by aiding in the interpretation of a study that: 1) tests a promising new treatment for mood and anxiety spectrum disorders; 2) evaluates a potential target in the brain which could serve as the basis for development of additional new candidate compounds for the treatment of patients with mood and anxiety spectrum disorders; 3) establishes more expeditious methods for evaluating potential new therapies for patients with mood and anxiety spectrum disorders; and 4) specifically establishes methods for the development of new therapies targeting anhedonia, an important RDoC (Research Domain Criteria) endpoint.
Imaging Serotonin 5HT1A Receptors in Patients With Major Depressive Disorder
Major DepressionUnipolar Depression2 moreBackground: - Medications to treat major depression act on a brain chemical called serotonin, which binds to receptors on brain cells. More research is needed on how serotonin receptors work in the brain, and imaging studies such as magnetic resonance imaging (MRI) can provide information on how these receptors function in the brains of individuals with depression and healthy volunteers. The experimental radioactive chemical [11C]CUMI has been designed to react with serotonin receptors, and researchers are interested in studying its effectiveness using positron emission tomography (PET) scanning to see how well it gets into the brain. Objectives: - To evaluate the effectiveness of the radiotracer [11C]CUMI in brain imaging studies of serotonin receptors. Eligibility: - Individuals between 18 and 55 years of age who either have been diagnosed with major depressive disorder or are healthy volunteers. Design: Participants will be screened with a full medical history, physical and psychiatric examination, blood and urine tests, and questionnaires about mood. Participants will also have an electrocardiogram at this visit. At the first study visit, participants will have a MRI scan of the brain to provide baseline data on brain function. At the second study visit, participants will have a PET scan with the [11C]CUMI contrast agent. No treatment will be provided as part of this protocol....
Sub-Trial of the Youth Readiness Intervention (YRI): Treatment of Control Group and Addition of...
Anxiety DisorderDepressive Disorder5 moreThis research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical trial by adding additional pre and post intervention data collection upon treatment of the control group (N=222) with the intervention which was proven effective in the larger trial. The overall research has investigated whether participation in the YRI intervention will improve emotional regulation, prosocial attitudes/behavior, social support and daily and functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will involve treatment of the control group with the effective YRI intervention, the investigators will add an additional measure of self-regulation as observed via DNA methylation in buccal cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered a free educational opportunity at the EducAid program in Freetown or in one of its upline/provincial sites. This stage of the research, as in the treatment with the main group, will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate improved attendance and behavior in a subsidized education program. In the previous phase of the trial, the investigators did observe significant effects for the YRI intervention and evidence that the program is indeed effective. For instance, post-intervention, YRI youth reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31), prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were non-significant at six-month follow-up for the full sample; moderator analyses showed that, for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements in emotion regulation and social support than controls. At eight-month follow-up, teachers reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31). In this final phase of the trial as the investigators treat the wait list control group, the investigators will test whether intervention effects observed in self-report data on improved emotion-regulation are also upheld in biomarker data. Thus, the investigators will now provide YRI treatment to the wait list control group and employ the use of biomarkers as a measure of the intervention's effectiveness. The objective of the study will be to assess whether DNA methylation (collected via cheek swabs of buccal cells) is associated with changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis that the YRI is associated with improvements emotion-regulation evidence both in self-report data on emotion-regulation and in buccal cell DNA methylation. This study will add to the evidence base for effective, culturally sensitive mental health services for youth and young adults affected by war and other forms of adversity.
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations
AnxietyBackground. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress. Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.
A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to...
AnxietyDepression1 moreThis virtual, open-label, three-group, randomized-controlled trial will last six weeks. Participants will be allocated into three groups; the Intervention Group, Spotify Group, and Control Group. All participants will complete a baseline questionnaire before completing their designated regime daily for six weeks. In addition, participants will complete study-specific surveys and validated questionnaires at the end of each week (Week 1, 2, 3, 4, 5 & 6). The study will include 75 [participants in total, 25 per group, who all have self-reported concerns around anxiety, stress, or depression. Questionnaires will be used to monitor sleep, cognitive ability, and changes in symptoms of anxiety, depression, and stress. Both study-specific questionnaires and validated questionnaires will be utilized, including the Generalized Anxiety Disorder Assessment (GAD-7), the 9-question Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS), and The World Health Organisation- Five Well-Being Index (WHO-5). Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
Exploring the Impact of " ACP Board Game for Life" on Death Preparation and Anxiety in Patients...
Chronic Kidney DiseaseChronic Renal Failure4 moreThis study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.
Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer...
Uterine Cervical NeoplasmsEarly Detection of Cancer2 moreWhen participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.
Patient Assessment, and Anxiety and Self-Confidence With Clinical Decision Making in Auscultation...
AnxietySelf-ConfidenceThis research is a randomized controlled experimental design. This research will be applied within the scope of the Health Assessment Course. The population of the research will be the students enrolled in the Health Assessment Course (n=138). The sample will consist of students who volunteered to participate in the research. Introductory Specifications Form, Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale, Auscultation of Heart, Lung, and Bowel Sounds Checklist, and Opinions of Students about the Auscultation Skills Training will be used in the implementation of the research. Permission was obtained from the Gazi University Ethics Committee and the Dean of the Faculty of Health Sciences to conduct the research. Informed consent will be obtained from the students who will participate in the research.
Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery...
Preoperative AnxietyPostoperative DeliriumThe effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.