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NCT ID: NCT03680625 Not yet recruiting - Pain Clinical Trials

Virtual Reality vs Passive Distraction for Pain Management

Start date: October 2018
Phase: N/A
Study type: Interventional

Background: Outpatient pediatric orthopedic procedures such as percutaneous pins removal are considered painful and generate significant anxiety in children. However, given their short duration and the need for a quick turnover in outpatient clinics, there are very few interventions aimed at relieving pain and anxiety related to these procedures. Neither simple analgesia nor topical anesthetics proved effective for procedural pain reduction with this population. Moreover, narcotics and procedural sedation do not appear to be feasible alternatives as they require surveillance, prolonging visit to the outpatient clinic and generating several undesired side effects. Therefore, it would be imperative to explore non-pharmacological pain management methods as they require minimal preparation and do not usually generate any side effects. Aim: To examine the effect of virtual reality (VR) compared to passive distraction, on pain, anxiety and memory of pain in children undergoing a percutaneous pin removal procedure in an outpatient orthopedic clinic. Hypothesis: VR distraction provides better pain relief during percutaneous pin removal procedures than passive distraction, in children from 7 to 18 years old. Methods: The study will be a prospective randomized controlled trial with parallel groups. Children from 7 to 18 years old, visiting the clinic for follow up and percutaneous pin removal procedure, accompanied by a parent or legal guardian will be recruited. The experimental group will receive a VR distraction through a head-mounted Oculus rift® and the control group will receive passive distraction through watching a video on an iPad®. The primary outcome will be the mean pain score after the procedure (self-report of pain level during the procedure) measured by the Numerical Rating Scale (NRS). Anxiety will be measured by the Child Fear Scale (CFS). Memories of pain and anxiety will be measured one week after the procedure using the same scales (NRS and CFS). The investigators aim to recruit 88 children to achieve a power of 80% with a significance level (alpha) of 5%. Discussion: The investigators believe that results of this study will allow to improve pain and anxiety management practices in this orthopedic clinic by showing that non-pharmacological interventions can be done, at very low cost, to improve the experience of the child undergoing this painful procedure through an innovative and more humanistic approach.

NCT ID: NCT03679949 Not yet recruiting - Pain Clinical Trials

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

Start date: October 1, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.

NCT ID: NCT03678168 Not yet recruiting - Pain Clinical Trials

A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

Start date: September 2018
Phase: N/A
Study type: Interventional

Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.

NCT ID: NCT03674489 Not yet recruiting - Pain Clinical Trials

Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls

Start date: October 2018
Phase: N/A
Study type: Interventional

Background & Significance Pain is the primary reason many patients seek care from healthcare professionals who utilize various manual therapy techniques. Gaining further understanding of the hypoalgesic properties of such techniques can enable practitioners to more skillfully integrate them in managing patients presenting with pain. Previous research has revealed that various manual techniques result in both local and widespread hypoalgesic changes in asymptomatic controls and patients in pain. Much of this previous research has investigated thrust manipulation; however, there is a paucity of similar research investigating these effects in neurodynamic mobilization. Specific Aims Aim: To assess for immediate local and widespread hypoalgesic effects of neurodynamic mobilization applied to the upper extremity. Hypotheses: - Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in local and widespread Qualitative Sensory Testing (QST) measures compared to those who receive a sham mobilization. - Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in elbow ROM and reported sensation intensity bilaterally with upper limb neurodyndamic (ULND) testing as compared to those who receive a sham mobilization. Aim: To assess for differences in immediate local and widespread hypoalgesic effects of sliding vs tensioning neurodynamic mobilization techniques applied to the upper extremity Hypotheses: - Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in local and widespread QST measures compared to those who receive tensioning neurodynamic mobilization - Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in elbow range of motion (ROM) and reported sensation intensity bilaterally with ULND testing compared to those who receive a tensioning neurodynamic mobilization

NCT ID: NCT03671317 Not yet recruiting - Pain Clinical Trials

Medical Clowns for Pediatric Blood Draw

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The research objective of this proposed clinical trial is to determine the efficacy of a medical clowning intervention for pediatric patients undergoing venipuncture. Efficacy is defined in terms of decreasing anxiety, pain, and crying duration, and increasing the pace and ease of the procedure. The study population includes pediatric patients between the ages of four to ten who must undergo venipuncture at the LAC + USC Outpatient Clinic. The subjects will be randomized into two groups. The control subjects will receive no intervention during blood draw, while the intervention subjects will receive medical clown intervention during blood draw. The clowns will interact with one patient at a time, engaging in play with the patient and caretakers during all parts of the procedure. Duration of crying and the duration of the entire procedure, the patient's level of pain and anxiety, the caretaker's level of anxiety, need for restraining devices (papoose) and the efficiency of the procedure will be measured. In order to perform the survey and self-assessment procedures, we will implement the use of measurement scales including the Faces Pain Scale, State-Trait Anxiety Inventory Form Y-1, Visual Analog Scale, and Children's Anxiety and Pain Scale. The data will be analyzed using descriptive statistics.

NCT ID: NCT03666858 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants

Start date: October 15, 2018
Phase:
Study type: Observational

The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.

NCT ID: NCT03661892 Not yet recruiting - Breast Cancer Clinical Trials

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

Start date: September 30, 2018
Phase: Early Phase 1
Study type: Interventional

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

NCT ID: NCT03634514 Not yet recruiting - Healthy Subjects Clinical Trials

Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects

Start date: August 27, 2018
Phase: Phase 4
Study type: Interventional

Randomized, Double-blind, Controlled, Crossover, in which 68 subjects (34 males and 34 females) will receive, in each stage, an application of 4 UI, subcutaneous, single dose, of the investigational drug (Recombinant Human Somatropin - Biomatrop) and the comparator (Recombinant Human Somatropin - Hormotrop) according to randomization to evaluate the Non-inferiority of Pain Intensity After the Application of Hormotrop, using Visual Analogue Scale (0-10cm) and record the incidence of adverse events.

NCT ID: NCT03634306 Not yet recruiting - Pain Clinical Trials

Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

This is a prospective blinded, randomized controlled study. The study will include three study arms: Patients undergoing laparoscopic hysterectomies will be randomized to one of either "Ultravision" (study arm 1) or "no Ultravision" (study arm 2, i.e. the current standard of care) groups. The study will be conducted blinded to the investigator during the procedure through patient discharge. The Ultravision system will be present in both, with the generator covered (not seen by user) and either on or off depending on the randomization. 30 patients will be enrolled, 15 per group. Five patients undergoing myomectomy will have their procedures conducted using the Ultravision (study Arm 3). Ultravision is cleared for use in all laparoscopic surgery i.e. including laparoscopic hysterectomy and myomectomy, in the United States. However, the clinical benefits arising from its use in gynecology have not yet been quantitatively assessed and published in an independent medical journal. Study Purpose: There are three main study objectives 1. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on the quality of visualization in the laparoscopic field 2. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on procedural characteristics 3. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on clinical outcomes.

NCT ID: NCT03628989 Not yet recruiting - Pain Clinical Trials

Technology-Based Distractions During Minor Procedures

Start date: August 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.