Clinical Research Directory

4-7-8 Breathing Before Colonoscopy: Effects on Anxiety, Pain, and Embarrassment

This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety, pain, and embarrassment. Colonoscopy is a procedure used to examine the inside of the large intestine and may cause anxiety, discomfort, and embarrassment in some patients. In this randomized controlled study, 104 patients undergoing colonoscopy were assigned to either an intervention group or a control group. Patients in the intervention group performed the 4-7-8 breathing technique before colonoscopy, while patients in the control group received usual care. Anxiety, pain, and embarrassment were assessed to compare outcomes between the two groups. This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety levels, pain intensity, feelings of embarrassment, and physiological parameters.

Screening Protocol

This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.

Options for Pain Management Using Nonpharmacological Strategies

The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore the Veterans' values and goals and how different non-medication approaches may fit into these values and goals.

Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain

The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery

The goal of this single-center, pragmatic, randomized, blinded, placebo-controlled trial is to evaluate the impact of intravenous (IV) lidocaine within the existing Enhanced Recovery After Surgery (ERAS)program on outcomes in patients after major non-cardiac surgery. The main questions the trial aims to answer are: The primary hypothesis is that utilization of IV lidocaine as part of a perioperative multimodal pain regimen will result in a reduction in hospital Case Mix Index-Adjusted Resource Length of Stay (CARLOS). The secondary hypotheses are that lidocaine infusion will result in a reduction in total inpatient opioid consumption (oral morphine milligram equivalents, oMMEs) and pain scores, and improved surgical outcomes (including return of bowel function, ileus, nausea, rapid responses called, surgical site infections, and ICU transfers), while also having minimal incidence of side effects (including double/blurry vision, tinnitus, sedation, and adverse events requiring early cessation).

Morphine or Ketamine for Analgesia

Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.

Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

EXORA Block vs Epidural Analgesia in Gynecological Surgery

This prospective observational study aims to compare the effects of the EXORA block and epidural analgesia on postoperative pain control and quality of recovery in patients undergoing gynecological surgery. Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, and postoperative pain will be evaluated using the Visual Analog Scale (VAS).

AI-Assisted Patient Education Before Suturing in Minor Trauma

Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. However, the realities of emergency department practice, including crowding, high patient volume, staff shortages, and increased workload, may limit effective nurse-patient communication and comprehensive patient education. Patients awaiting suturing for minor trauma often experience uncertainty, prolonged waiting, fear of the procedure, and concern about pain. These factors may increase anxiety, which can further intensify pain perception and negatively influence patients' cooperation with treatment and satisfaction with care. Previous reports indicate that many patients waiting in emergency departments seek information about waiting times, care processes, and their medical conditions, highlighting a substantial need for accessible and reliable information. During this waiting period, patients may increasingly use artificial intelligence-based digital resources to obtain information about their health condition and the procedure they are about to undergo. However, information generated by artificial intelligence may be inaccurate, incomplete, or insufficiently tailored to the clinical context. Therefore, such information should be reviewed and validated by healthcare professionals before being provided to patients. This study aims to evaluate the effect of an artificial intelligence-assisted patient education material delivered during the pre-suturing waiting period on pain and anxiety levels among patients with minor trauma in the emergency department. It is also expected that the educational material developed within the scope of this study may contribute to patient education and supportive care in emergency department settings.

THE EFFECT OF VIRTUAL REALITY USE IN CYSTOSCOPY ON PAIN, ANXIETY, AND COMFORT: A RANDOMIZED CONTROLLED TRIAL

This study aims to evaluate the effects of virtual reality (VR) distraction on pain, anxiety, and comfort levels patients undergoing cystoscopy. Cystoscopy is a common diagnostic procedure in urology that can cause physical discomfort and anxiety in patients. This randomized controlled trial assigns eligible participants to either an experimental group receiving VR video distraction during the procedure or a control group receiving standard care without VR intervention. Pain, anxiety, and comfort levels are assessed and compared between the two groups using standardized measurement tools.

Elevated Midline Positioning During Diaper Change in Preterm Infants

Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants. During a conventional diaper change the infant is often kept in a side-lying position with the head turned to one side, which may impair jugular venous drainage. In contrast, 30-degree head-of-bed elevation with the head kept in the midline has been shown to lower intracranial pressure and is a core component of intraventricular hemorrhage prevention care bundles. No randomized controlled trial has yet examined the effect of this position during diaper change. The purpose of this randomized controlled trial is to determine whether 30-degree elevated midline positioning during a routine diaper change, compared with standard care (diaper change in a flat, side-lying position), reduces oxygen desaturation and bradycardia episodes, lowers pain/stress scores measured with the Neonatal Infant Pain Scale (NIPS), and shortens the time needed for heart rate and oxygen saturation to return to baseline in stable preterm infants born at 28-34 weeks of gestation. Eighty infants (40 per group) in the level III NICU of Antalya City Hospital, Türkiye, will be randomly assigned to one of the two groups. Each infant will be evaluated during a single diaper change performed after 96 hours of postnatal age.

Clinical and Scientific Assessment of Pain and Painful Disorders

Background: Researchers want to better understand pain by studying people with and without different kinds of pain. To do this, researchers will expose people to pleasant and unpleasant sensations. They will ask them questions about their pain. Researchers also want to see if these people are eligible for other research studies at the National Center for Complementary and Integrative Health. Objectives: To study the experience of pain. Also to find people eligible to join other NIH studies. Eligibility: People 12 years and older with and without pain disorders. Design: Participants will be screened by phone. Participants will have one required visit lasting about 2 hours. This may include: * Medical history * Physical exam * Questionnaires about themselves and their pain experience * Blood and urine tests * MRI: They will lie on a table that slides into a cylinder. They will feel different sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours. * Quantitative sensory testing: They will be exposed to different pictures, sounds, tastes, and smells. They will also be exposed to pleasant and unpleasant sensations. These could include: * Burning, itching, or cold sensations * Pinpricks * Pressure and pinches * Electrocardiogram: Stickers on the chest record heart activity. * Straps placed around the chest to measure breathing. * Small sensors on the fingers or palms to measure pulse and sweating. Participants may have up to 12 other outpatient study visits. Participants may be recorded at the visits.

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.

An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin

The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.

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

Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing

The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.

Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling. The study also measures the time spent on blood sampling.

One vs Two Visits Root Canal Treatments in Infected Teeth

The primary aim of the study is to compare the outcome of one vs two visits endodontics (root canal treatments) performed in general dental practice of infected (necrotic) teeth, one and four years after treatment. Secondary aims are to compare the root filling quality and the frequency of complications for both treatment modalities. A pilot study will identify the shortcomings of the protocol, which will be revised accordingly. A multi-center study in several clinics from five counties throughout Sweden is planned. Consecutive eligible patients (see inclusion and exclusion criteria) with one tooth each will be included. The study sample size calculation was based on a judgement that a minimal worthwhile effect of less than 10% was not clinically relevant. The presumption was that successful outcomes would be of 75% and 65% for the different treatment arms, respectively. Three hundred and fifty six patients per group are thus needed to detect that difference as statistical significant with a power of 80% and an alfa-error of 5%. To compensate for around 30% drop-outs a number of 1000 patients will be recruited. Patients will be randomly enrolled in two arms: one in which the endodontic treatment (root canal treatment) is performed in one visit, and in the other arm in two visits. The allocation sequences for one vs multiple visit endodontics will be computer generated followed by a dark colored envelope concealed allocation. The patients will be contacted by telephone 5-7 days post-operatively, and a control visit at the clinic will be scheduled one month post-operatively to assess complications related to the treatment. A clinical control will be performed at the clinic one and four years after treatment. Intra-oral radiographs will be taken. The radiographs will be examined by two blinded and independent observers. A successful outcome is defined by clinical and radiographic normalcy. The statistical methods selected to analyse the primary outcome will be the Chi square test of 2x2 tables, or Fisher´s exact test when proportions are small and the expected value \<5. The calculations will be two-tailed. Results will be considered statistically significant at p\<0.05.

Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)

In this study, total knee replacement patients will be determined to be stiff or non-stiff preoperatively. Stiffness designation is determined by preoperative range of motion (if flexion is \< 100 degrees, or extension lag is \> 10 degrees). The stiff and non-stiff groups will both be randomized to two groups to receive either intravenous hydrocortisone or a placebo at 3 intervals postoperatively. Patients will be followed up with in hospital and via the phone on postoperative day (POD) 1 and 2, as well as 6 weeks, 6 months, 1 year, and 2 years postoperatively. Patients will also have blood drawn preoperatively in the OR, on POD1, at their 6 week followup, and at their 1 and 2 year follow ups. This blood will be processed and analyzed.

The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis

Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, and electrotherapy. However, these conventional methods may be limited by factors such as lack of motivation, pain-related avoidance behavior, and poor treatment adherence. Today, immersive virtual reality technologies introduce a new dimension to rehabilitation by gamifying exercise, providing sensory feedback, and enabling graded exposure through mechanisms such as distraction and engagement. They also enhance motivation and compliance with exercise programs. Studies in the literature have reported that virtual reality-based exercise is an effective method for reducing pain levels in patients diagnosed with frozen shoulder. However, only a limited number of studies have specifically examined the effects of immersive virtual reality in patients with adhesive capsulitis. To date, no study has investigated the impact of immersive virtual reality interventions on sleep and cognitive functions in these patients. Furthermore, the combined effect of patient education, home exercise programs, and immersive virtual reality therapy has not yet been explored. For these reasons, the present study aims to investigate the effects of immersive virtual reality-based exercise therapy on pain, functionality, sleep, and cognitive functions in patients with Grade 1-2 adhesive capsulitis.

Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions. By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population.

Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block in Thoractomy

The objective of the current study is to compare the efficacy of the analgesic effect of ultrasound-guided unilateral Rhomboid intercostal and sub serratus plane block (RISS) versus Serratus anterior plane block (SAPB) in Thoracotomy incision.

Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures

This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.

Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction

The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.