Clinical Research Directory

THE EFFECT OF SKIN-TO-SKIN CONTACT ON PAIN AND ANXIETY DURING EPISIOTOMY REPAIR

Episiotomy is a surgical incision made in the perineum during the second stage of labor. The suturing (repair) process following episiotomy causes significant acute perineal pain and state anxiety in women due to the rich nerve supply of the perineum. Although the physiological and psychological benefits of early skin-to-skin contact (SSC) for mothers and newborns are widely reported in the literature, studies evaluating the effects of SSC on maternal pain and anxiety during episiotomy repair, when surgical stress is intense, are limited. The aim of this study is to investigate the effects of early skin-to-skin contact during episiotomy repair on women's pain and state anxiety levels and to compare the group receiving SSC with the group receiving standard routine care. The study will be conducted as a randomized controlled experimental study, and the sample size has been calculated using power analysis. The data collection tools will include the Descriptive Information Form, Visual Analog Scale (VAS), and Spielberger State Anxiety Inventory. SSC applied during repair stimulates endogenous oxytocin release, reduces hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system activity, supports the parasympathetic system, and provides natural analgesic and anxiolytic effects. It also shifts the mother's attention from the pain of the surgical procedure to her baby. Conducted within the framework of woman-centered midwifery care, this study aims to address the gap in the literature regarding the analgesic and anxiolytic effects of SSC during episiotomy repair and to contribute evidence-based knowledge to clinical midwifery practice.

The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels

The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.

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.

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.

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.

Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis

Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis . Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone. Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p \<0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.

A Study Evaluating the Impact of a Painkiller Product on Quality-of-Life and Daily Functioning

The aim of this study is to generate real-world, consumer reported evidence on the perceived impact of headache relief with Panadol/Dolex on Quality of Life (QoL) and daily functioning.

Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements. The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group. The secondary outcomes are as follows: * Type and dose of analgesia * Conductance scores/values * Anxiety levels * Patient satisfaction * Procedure duration * Adverse events Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not

Mindfulness Intervention on Minimally Invasive Vascular Surgery

The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction. The main questions this study aims to answer are: * Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care? * Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups. Participants in the VR-based mindfulness group will: * Receive a VR-based mindfulness session in the preoperative waiting area. * Begin a VR-based mindfulness session at the start of surgery. The intraoperative intervention will be repeated till the end of surgery. Participants in the control group will receive routine psychological care before and during surgery. Participants in both groups will: * Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, following the first completion of intraoperative VR-based mindfulness session, and after surgery. The third assessment will be conducted at the corresponding intraoperative time point in the control group. * Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery. * Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery. * Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day. * Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day. * Complete a satisfaction assessment on the first postoperative day.

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).

Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb

The goal of this randomized controlled clinical trial is to evaluate the effectiveness of postoperative bupivacaine infusion through a perineural catheter in managing postoperative pain and to determine the opioid consumption among patients undergoing major lower-limb amputation surgery. The main questions it aims to answer are: * Does postoperative bupivacaine infusion through a perineural catheter provide better postoperative pain control as compared to intravenous opioid analgesia alone? * Does postoperative bupivacaine infusion through a perineural catheter reduce intravenous opioid consumption within the first 48 hours after surgery compared with intravenous opioid analgesia alone? * Does the postoperative Bupivacaine infusion through perineural catheter help in reducing the phantom pain at 6 months follow-up?

Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.

Characterizing the Effects of Platelet-Rich Fibrin (PRF) as a Palatal Wound Dressing on Quality of Life and Sleep Following Mucogingival Surgery. Study Was Conducted at the Air Force Post Graduate Dental School. All HIPPA Consents and Research Informed Consents Are Located at JBSA-Lackland.

The goal of this clinical trial (2-arm) is to determine if the application of platelet rich fibrin (PRF) to palatal donor sites influence patients quality of life, sleep efficiency, and healing following mucogingival surgery. All patients were enrolled in the Air Force Post Graduate Dental School periodontics program and each patient required mucogingival surgery. The main question\[s\] it aims to answer \[is/are\]: * Does the application of PRF to palatal donor sites influence patient's quality of life following mucogingival surgery. \[outcome measure 1\] * Does the application of PRF to palatal donor sites influence patient's sleep quality following mucogingival surgery. \[outcome measure 2\] * Does the application of PRF to palatal donor sites influence palatal healing following mucogingival surgery. \[outcome measure 3\] Researchers will compare the application of PRF (test) as a palatal dressing to a commercially available product (control; oxidized cellulose membrane or collagen dressing) to determine the difference of effects. Participants will be randomly assigned to either receiving PRF or a commercially available product on the day of surgery. A survey response will be conducted at five time points (pre-operative, 24-hours, 72 hours, 1 week, 2 week) to obtain a quality of life metric. Sleep data was collected via a wearable device one week pre-surgical intervention and two weeks postoperatively. Finally, a clinical healing index was performed at 1 and 2 weeks post-operatively to obtain a healing score.

Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study

Background: In the intensive care unit (ICU), delirium in patients and long-term mental health challenges in both patients and their family members are highly prevalent. To address these issues, patient- and family-centered care has been recommended to alleviate the burdens associated with critical illness and ICU admission. We have developed the patient- and FAMily-centered care in the adult ICU intervention (FAM-ICU intervention). This multi-component intervention comprises several concrete and manageable components and operationalizing patient- and family-centered care principles in clinical practice. In this protocol, we describe a study aiming to evaluate the feasibility and acceptability of the FAM-ICU intervention in the adult ICU setting, including the feasibility of collecting relevant patient- and family-member outcome data. Referenc: Bohart et al. 2024. Acta Anaesthesiol Scand . 2025 Jan;69(1):e14539. doi: 10.1111/aas.14539. Epub 2024 Oct 24. Method: We will conduct a pre-/post two-group study design. We plan to recruit 30 adult ICU patients and their close family members at Herlev University Hospital in Denmark. The pre-group (n = 15) will receive usual care and the post-group (n = 15) will receive the FAM-ICU intervention. The FAM-ICU intervention involves interdisciplinary training of the ICU team and a systematic approach to information sharing and consultations with the patients and their family. Feasibility outcomes will include recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Acceptability will be assessed through questionnaires and interviews with clinicians, patients, and family members. Data collection is scheduled to begin in January 2025. Discussion: This study will assess the feasibility and acceptability when implementing the FAM-ICU intervention and the feasibility of conducting a main trial to investigate its effectiveness on delirium in patients and the mental health of patients and family members. The data from the feasibility study will be used to guide sample size calculations, trial design, and final data collection methods for a subsequent stepped-wedge randomized controlled trial.

Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.

The purpose of this study is to check the anesthetic effectiveness of 4% Articaine and 2% Lidocaine in IANB Vs Mental nerve block in 1st and 2nd premolars with symptomatic Irreversible Pulpitis. This study aims to compare and find the best possible anesthetic solution amongst 2% Lidocaine and 4% Articaine and technique ie IANB Vs Mental Nerve block to make endodontic procedure pain free or comfortable for the patient

Evaluation of Pain Treatment After Total Knee Arthroplasty

The purpose of the study is to characterize opioid use after total knee arthroplasty (TKA).

Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial

Cesarean delivery is one of the most frequently performed major surgical procedures worldwide. The postcesarean period is characterized by moderate to severe pain, which may adversely affect postoperative recovery, patient satisfaction, breastfeeding success, and maternal-infant bonding. Current guidelines recommend a multimodal approach to postcesarean analgesia that reduces opioid consumption and minimizes adverse effects. The Procedure-Specific Postoperative Pain Management working group recommends multimodal protocols for elective cesarean delivery that combine systemic analgesics (regular paracetamol and nonsteroidal anti-inflammatory drugs, neuraxial intrathecal morphine, and/or abdominal wall blocks, such as transversus abdominis plane and quadratus lumborum blocks.

Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)

The investigators collected 200 patients underwent safe uncomplicated laparoscopic cholecystectomy, then different strategies of pain control are used.

Virtual Reality Distraction During Restorative Dental Treatment

This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.

Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis

The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it. The main questions are: * Does ashwagandha affect mental well-being and quality of life compared with placebo? * Does it affect physical health, perceived stress, or endometriosis-related quality of life? * Does it affect pain during intercourse or how participants manage pain, including pain medication use? * What side effects or changes in blood test results occur during supplementation? Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase. Participants will: * Take 300 mg of ashwagandha or placebo daily for 12 weeks. This may extend to 16 weeks to match assessments with the menstrual cycle. * Complete questionnaires about quality of life, stress, pain during intercourse, and pain management. * Attend regular clinic visits for health checks and blood tests. * Attend a follow-up visit about four weeks after finishing the study capsules. After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects. Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.

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

Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia

The present study will evaluate the effectiveness of Buzzy Bee in reducing pain and physiological responses during maxillary buccal infiltration in children aged 5-7 years compared with a conventional injection protocol.

Tourniquet Exposure and Risk of Chronic Pain After Severe Limb Trauma

Severe limb trauma often requires the use of a tourniquet to stop life-threatening bleeding. While tourniquets are essential for saving lives, prolonged interruption of blood flow may lead to tissue ischemia, nerve injury, and inflammatory responses that could contribute to the development of chronic pain. The TOURNI-PAIN Study is a prospective observational study designed to investigate whether the duration of tourniquet use during the treatment of severe limb injuries is associated with an increased risk of persistent pain after recovery. The study will enroll adult patients with major upper or lower limb trauma who required tourniquet application in the prehospital or hospital setting. Researchers will collect information about the duration and characteristics of tourniquet use, details of the injury, surgical treatment, and recovery. Participants will be followed for up to 6 months after injury to assess pain levels, possible neuropathic pain, functional recovery, and quality of life. The goal of this research is to better understand whether longer tourniquet exposure increases the risk of long-term pain. The findings may help improve trauma care practices by balancing the life-saving benefits of hemorrhage control with strategies that minimize long-term complications and improve recovery for patients with severe limb injuries.