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Pain clinical trials

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NCT ID: NCT03902158 Recruiting - Pain Clinical Trials

Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1). The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.

NCT ID: NCT03897998 Recruiting - Pain Clinical Trials

Neural Correlates of Hypoalgesia Driven by Observation

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Placebo effects held an ambivalent place in health care for at least two centuries. On the one hand, placebos are traditionally used as controls in clinical trials to correct for biases and the placebo response is viewed as an effect to be factored out in order to isolate and accurately measure the effects of the treatment. On the other hand, there is scientific evidence that placebo effects represent fascinating psychoneurobiological events involving the contribution of distinct central nervous as well as peripheral physiological mechanisms that influence pain perception and clinical pain symptoms and substantially modulate the response to pain therapeutics. Therefore, placebo effects have shifted from being a challenge for clinical trials to a resource to trigger the reduction of pain based on endogenous mechanisms that can be activated in the brain to promote hypolagesia, self-healing, and well-being. This is relevant in acute pain settings given that chronic opioid users die within approximately 2.5 years of being prescribed their first opioid medication to treat acute pain. The overall hypothesis is that observational learning influences neural pain modulation and cognition systems, including processes associated with mentalizing (the ability to cognitively understand mental states of others), empathy (the ability to share an emotional experience), and expectancy (the anticipation of a benefit). The objective is to determine the brain mechanisms of observationally-induced analgesia using brain mapping approaches that target changes in blood oxygenation and oscillatory activity in the brain, thus enabling investigators to draw inferences about the localization and extent of neurobiological activation underlying hypoalgesia driven by observation. Therefore, the investigators designed innovative experiments using pharmacological fMRI, EEG, and combined EEG-fMRI measurements.

NCT ID: NCT03880084 Recruiting - Pain Clinical Trials

Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)

NIVILIUM
Start date: August 1, 2019
Phase:
Study type: Observational

Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.

NCT ID: NCT03877991 Recruiting - Pain Clinical Trials

Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations

Start date: February 19, 2024
Phase: Early Phase 1
Study type: Interventional

The oral bio-availability of cannabidiol (CBD) is low due to poor water solubility and susceptibility to extensive first pass metabolism, resulting in relative bio-availability of 6%.This project is designed to evaluate the plasma concentration vs. time profile of a self emulsifying drug delivery system termed Long Chain Nano Lipospheres (LNL) for enhancing the oral bio-availability of cannabidiol (CBD). The main goal of this study is to evaluate the bio-equivalence of CBD in the LNL product, compared to CBD in a sesame oil vehicle and CBD without any formulation, in powder form. Bio-equivalence is measured by AUC 0-24h, Tmax and Cmax.

NCT ID: NCT03858790 Recruiting - Pain Clinical Trials

Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain

Start date: February 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.

NCT ID: NCT03855111 Recruiting - Pain Clinical Trials

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. In HIV there are no FDA-approved drugs for this indication. This study assesses in a randomized controlled clinical trial, the efficacy of novel non-pharmacologic pain management approaches to reduce HIV-related DSP pain and improve quality of life.

NCT ID: NCT03831321 Recruiting - Pain Clinical Trials

The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy

Start date: December 11, 2018
Phase: Phase 4
Study type: Interventional

The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug. Parameters: 1. Visual Pain Score during cystoscopy 2. Cystoscopy comfort - a questionnaire to be filled by the doctor 1. Excellent 2. Very good 3. Good 4. Bad 5. Too bad 3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor. Post-Op: 1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency 2. 24th Hour dysuria, Frequency, A total of 144 patients, we plan to arrive at the end of 1 month.

NCT ID: NCT03823742 Recruiting - Clinical trials for Irritable Bowel Syndrome

Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?

Start date: February 22, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from CBT or from the low FODMAPs diet.

NCT ID: NCT03823534 Recruiting - Pain Clinical Trials

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Start date: February 20, 2019
Phase: Phase 3
Study type: Interventional

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

NCT ID: NCT03821298 Recruiting - Pain Clinical Trials

Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis

CMC
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12 months follow up.