Clinical Research Directory

Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips

This randomized split-mouth controlled clinical trial will compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips and conventional dental needle tips. Sixty adult patients requiring bilateral maxillary anterior infiltration anesthesia will receive injections with both needle types in a randomized order. Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS). The study aims to determine whether the Transcodent needle tip reduces injection-related pain compared with a conventional needle tip, thereby improving patient comfort during routine dental procedures.

Advancing Patient Care for Lymphatic Pain and Lymphedema

Lymphatic pain refers to various pain sensations (e.g., pain, aching, soreness, tenderness, burning, stabbing) following breast cancer treatment. Lymphatic pain affects more than half of 4 million patients treated for breast cancer in the United States. Lymphatic pain significantly impairs patients' daily living function, increases psychological distress, and decreases quality of life. As a significant risk of lymphedema, lymphatic pain indicates an early stage of lymphedema. Lymphedema is a chronic and incurable swelling caused by an abnormal fluid build-up following breast cancer treatment. Without timely intervention in this early stage, lymphedema can progress into a chronic condition that no surgical or medical interventions can cure. The purpose of the project is to adapt The-Optimal-Lymph-Flow (TOLF) in clinical practice. A digital lymphatic pain and lymphedema assessment will be implemented in clinical practice, conduct clinician training and deliver TOLF Self-Care interventions to patients with lymphatic pain.

Comparing Pre-Anesthetic Approaches in Dentistry

The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches: Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.

Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia

Postoperative pain remains a common clinical challenge in patients undergoing video-assisted thoracoscopic surgery (VATS), impairing early recovery and increasing opioid consumption. The serratus anterior plane block (SAPB) is a widely used regional analgesic technique for thoracic surgery, but conventional single-point injection may have limited spread of local anesthetics, resulting in suboptimal analgesia in some patients. Preliminary anatomical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and better analgesic efficacy. This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 adult patients scheduled for elective unilateral VATS will be consecutively enrolled and naturally assigned to either the two-point combined SAPB group (injection at the 3rd and 5th rib levels, total 30 ml local anesthetic) or the single-point SAPB group (injection at the 5th rib level, 30 ml local anesthetic) according to routine clinical practice. The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and Quality of Recovery-15 (QoR-15) scores. This study aims to provide clinical evidence for optimizing perioperative analgesic strategies for thoracoscopic surgery.

Testing the Pain Clinical Practice Guideline

There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Long-Term Care Medicine. There are, however, many challenges to translating the use of Clinical Practice Guidelines into clinical settings. To overcome these challenges we developed and previously tested a theoretically based approach and merged this approach with the Pain Management CPG, which is referred to as the PAIN-CLINICAL PRACTICE GUIDELINE-USING THE EVIDENCE INTEGRATION TRIANGLE (PAIN-CPG-EIT). The PAIN-CPG-EIT involves a research nurse facilitator working with an identified community champion(s) and stakeholder team for 12 months to provide the following four components: Component I: Establishing and meeting monthly with a Stakeholder Team; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain; Component IV: Ongoing evaluation of resident pain outcomes. Twelve communities will be included with 25 residents living with dementia and pain recruited from each community. Six communities will be randomized to treatment (PAIN-CPG-EIT) and six randomized to education only (EO) which involves providing the same education to staff as is done in Component II of PAIN-CPG-EIT. The primary aim of this study is to test the effectiveness of use of the PAIN-CPG-EIT to improve the assessment, diagnosis and management of pain and decrease pain intensity among nursing home residents living with dementia between baseline, 4 and 12 months and evaluate treatment fidelity. A secondary aim of the study is to consider differences in measurement, treatment and response to treatment between male and female and Black versus White residents living with dementia. Findings from this study will help build on the currently limited information about pain presentation and management among older adults living with dementia in nursing homes and improve health equity of aging populations experiencing pain.

Fundamental Intelligent Building Blocks of the Intensive Care Unit (ICU) of the Future: Intelligent ICU of the Future

The objective of this project is to create deep learning and machine learning models capable of recognizing patient visual cues, including facial expressions such as pain and functional activity. Many important details related to the visual assessment of patients, such as facial expressions like pain, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses or are not captured at all. Consequently, these important visual cues, although associated with critical indices, such as physical functioning, pain, and impending clinical deterioration, often cannot be incorporated into clinical status. The study team will develop a sensing system to recognize facial and body movements as patient visual cues. As part of a secondary evaluation method the study team will assess the models ability to detect delirium.

Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain

This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.

Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention

This project is a single-site, two-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room an audio-recorded mindfulness practice decreases their pain relative to an injury management control condition.

Correlation of Pain Intensity Measurements in Healthy Volunteers Exposed to Unpleasant Stimuli

Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. There are many ways to measure pain, both through patient self-report (scales) and objective physiological indicators. However, there is no single, universal tool for measuring pain intensity that is simultaneously reliable, valid, and easy to use. Moreover, there are reports showing that not only the intensity of the unpleasant experience but also the nature of the stimulus can cause different levels of changes in the used indicators and scales. In this project, we will compare two devices used for pain monitoring based on physiological parameters: PainMonitor (Med-Storm, Oslo, Norway) and ANI Monitor (MetroDoloris, Loos, France). PainMonitor is a device that records skin conductance (SC) as an indicator of pain intensity. SC reflects the level of autonomic nervous system arousal. The device automatically analyzes these parameters and provides a numerical indicator of pain intensity/anesthesia level. The ANI Monitor is a device based on the analysis of parasympathetic nervous system activity through heart rate variability analysis. Based on this, the device also assesses the degree of pain intensity and presents it in numerical form. The aim of the project is to investigate the correlation between PainMonitor and ANI as tools for measuring pain intensity in situations where healthy volunteers are exposed to various unpleasant stimuli. The study will involve approximately 100 healthy adult participants who will be exposed to three types of standardized stimuli: thermal (hot and cold), mechanical (pressure from a blood pressure cuff, pressure on a skin fold), chemical (spicy taste), and visual. Simultaneously, they will be monitored by PainMonitor, ANI, ECG, and peripheral perfusion index (using pulse oximetry). This data will then be compared and subjected to statistical analysis to determine if there is a relationship between the nature of the stimuli used and the objective and subjective indicators of pain intensity. Stimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes: 1. NON-INVASIVE BLOOD PRESSURE MEASUREMENT: Non-invasive blood pressure measurement (NIBP) (single automatic blood pressure measurement using a Phillips IntelliVue Monitor). 2. HEAT: A metal cube with a temperature of 45 degrees Celsius will be used for heat stimulation. The cube will be applied for 60 seconds to the inner side of the forearm of the participant's dominant hand. The appropriate temperature of the cube will be maintained by keeping it in a water bath. 3. ALGOMETER: For mechanical stimulation, the researcher will apply pressure to the skin fold between the second and third fingers of the dominant hand using an algometer. The pressure will gradually increase from 0 to 250-300 kilo Pascal (kPa) and be maintained for 60 seconds. 4. VISUAL STIMULUS: For visual stimulation, a video will be shown on a display in front of the participant, depicting a model having a short intravenous cannula inserted. Participants will be asked to imagine that the hand on the screen is their own. 5. COLD: "Cold pressor test" - The participant's forearm will be immersed in water at a temperature of 2 degrees Celsius for 60 seconds or until discomfort causes the participant to withdraw their hand. 6. SPICY TASTE: 0.5 ml of spicy sauce with a specified amount of Scoville units will be applied to the participant's tongue using a syringe.

Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study

Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms. The purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care. The secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement. Lastly, the third aim is to explore participants' experiences with Reiki through guided interviews. Participants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups: Immediate Reiki Group: If participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience. Waitlist Group: If they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience. The investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.

Determination of Chronic Pain, Anxiety, Depression and Perceived Stress in Adults With Temporomandibular Disorders

The aim of the study was to asses levels and relationship of chronic pain, anxiety, depression and perceived stress in TMD patients .

Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement

Medical and technological advancements allow increasingly complex invasive procedures to be performed on hospitalized patients, improving their survival rates and prognosis. However, these interventions impact physical, emotional, and psychological health. In this scenario, post-hospitalization syndrome (PHS) emerges as a concerning phenomenon characterized by functional, emotional, and social decline after discharge. Invasive procedures such as surgeries or prolonged use of catheters not only compromise physical integrity but also contribute to disorders like anxiety, depression, and post-traumatic stress. In fact, between 20% and 30% of patients admitted to the Intensive Care Unit (ICU) develop symptoms compatible with post-traumatic stress disorder. This underscores the need for a comprehensive approach focused on psychological and social well-being during and after the hospital stay. Despite humanization initiatives, few hospitals successfully implement them due to a lack of objective evaluations and clinical recommendations that justify their necessity. In this regard, venous catheterization (VC) is the most prevalent invasive procedure. The pain, anxiety, or fear caused by this technique triggers physiological and psychological alterations that can interfere with the successful insertion of the device. This stress response induces vasoconstriction, reducing the caliber of the vein, which increases technical difficulty, elevates the risk of complications, raises healthcare costs, and negatively impacts patient satisfaction. Natural outdoor environments have been shown to reduce stress, enhancing well-being and health in the general population. In this sense, the use of immersive virtual reality (IVR) to achieve immersion in virtual nature could help not only by diverting attention away from the painful or anxiety-inducing stimulus during invasive procedures but also by providing pleasant stimuli that could have a physiological impact. The objective of this study is to evaluate the impact of IVR on stress and anxiety during VC using validated clinical scales, measuring the caliber of the vessel to be punctured, and determining salivary biomarkers of stress, well-being, and pain. Confirming this hypothesis will provide the evidence to integrate virtual reality into the National Health System as a standard tool for more humanized and innovative care.

Relationship Between Selected Parameters and Bruxism

Bruxism is a common phenomenon. It is estimated that its prevalence in the adult population is 8-31%. Bruxism occurring during sleep is the activity of the masticatory muscles that appear during sleep, which can be rhythmic or phased and is not a movement disorder or sleep disorder in healthy people. It is currently believed that bruxism should not be considered a disorder. In healthy people, it is treated rather as behavior, which may be a risk factor for pathological clinical implications or a protective factor in the presence of other disease entities. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, periodontal and oral mucosa damage, myalgia in the stomatognathic system, headache and prosthetic restoration damage. However, due to nocturnal occurrence, bruxism symptoms may go unnoticed for a long time, which means that patients are often unaware of this behavior. The etiology of bruxism is multifactorial and not fully understood. It is currently believed that it can be caused by genetic, psychological and exogenous factors. Due to the unclear etiology of bruxism, it is so important to conduct research that allows making a certain diagnosis and finding the causes of this phenomenon

Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers

Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain. The name of the study smartphone application involved in this study is: -STAMP+CBT

Association of Expectations and Pain Relief After Diagnostic Nerve Blocks

Expectations are a major driver of changes in health-related outcomes and are related to reduced pain after medical treatment. However, no studies have specifically addressed the role of expectations in connection with the success of interventional pain techniques and the specific effect of expectations on diagnostic and therapeutic procedures in this field. Further, there are no studies on prolonged pain reduction after diagnostic nerve blocks. This prospective cohort study will investigate patients' outcome-related expectations measured by validated questionnaires (i.a. the Expectation for Treatment Scale) before standardized diagnostic nerve blocks (i.e. lumbar medial branch and greater occipital nerve blocks) and their association with immediate pain reduction, calculated using a numeric rating scale (NRS) before and after the block. Secondary outcomes are specificity of pain relief duration in relation to the local anesthetic, changes in pain-related interference, quality of life and function, as well as patients' global impression of change after one week in order to assess possible therapeutic effects of the nerve blocks themselves. The sample size of 110 patients is based on a power of 80% and a significance level of 0.05. Additional endpoints will be evaluated using mixed-effects linear regression, non-linear relationships between expectation and endpoints will be modelled using fractional polynomials. This research will quantify the effect of patients' expectations on pain reduction after nerve blocks, extend our knowledge which patients are likely to respond to interventional pain treatments and under which circumstances nerve blocks may exhibit therapeutic effects.

A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy

Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited. Objective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms. Hypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority). Study plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (VR TMD EEG)

This project examines, in chronic pain, the mechanisms of immersive virtual reality compared to the mechanisms of placebo hypoalgesia. The potential of developing new non-pharmacological premises for low-risk interventions for pain management is high.

RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use \- and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Cannabis Effects as a Function of Sex

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

Neural and Psychological Mechanisms of Pain Perception

Background: \- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision. Objectives: \- To better understand how pain and emotions are processed and influenced by psychological factors. Eligibility: \- Healthy volunteers ages 18-50. Design: * This study requires 1 to 2 clinic visits that last 1 to 3 hours. * Participants will be screened with medical history and physical exam. * Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs. * Participants' heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored. * Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI. * Participants will fill out questionnaires. * The study will last 3 years.

Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.

Pervasive Sensing and AI in Intelligent ICU

Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all. Consequently, these important visual cues, although associated with critical indices such as physical functioning, pain, delirious state, and impending clinical deterioration, often cannot be incorporated into clinical status. The overall objectives of this project are to sense, quantify, and communicate patients' clinical conditions in an autonomous and precise manner, and develop a pervasive intelligent sensing system that combines deep learning algorithms with continuous data from inertial, color, and depth image sensors for autonomous visual assessment of critically ill patients. The central hypothesis is that deep learning models will be superior to existing acuity clinical scores by predicting acuity in a dynamic, precise, and interpretable manner, using autonomous assessment of pain, emotional distress, and physical function, together with clinical and physiologic data.

State of Hormones Impact Nociceptive Expression

The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW \> CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.

Peloid Therapy in Temporomandibular Joint Dysfunction

This prospective, single-group clinical study will evaluate whether local peloid therapy improves pain and jaw function in adults with temporomandibular joint dysfunction. Participants will receive peloid therapy applied to the temporomandibular joint region and masticatory muscles for 20 minutes per session, 5 days per week, for 2 weeks. Pain and functional outcomes will be measured at baseline and at the end of treatment using validated clinical scales, including the Jaw Functional Limitation Scale-8, visual analog scale pain scores, Fonseca index, maximum mouth opening, and secondary otalgia assessment.