Clinical Research Directory

BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).

Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.

Rotator cuff tears are among the most common direct and indirect causes of chronic shoulder pain. Patients with irreparable rotator cuff tears face a choice of pain management options. The principal treatments available for chronic shoulder pain associated with irreparable rotator cuff tears include arthroscopic tenotomy of the long head of the biceps tendon, shoulder arthroplasty, pharmacological treatment, and radiofrequency ablation of the suprascapular nerve. Arthroscopic tenotomy of the long head of the biceps tendon is an established treatment for pain associated with massive irreparable rotator cuff tears, as supported by the available literature. Radiofrequency ablation of the suprascapular nerve provides temporary pain control by destroying the sensory nerve fibres supplying the shoulder joint. Tenotomy of the long head of the biceps tendon can be performed safely using a minimally invasive, ultrasound-guided outpatient procedure under local anaesthesia, without the general anaesthesia required for arthroscopy. The aim of the study is to compare the reduction in pain intensity and the duration of analgesia following percutaneous tenotomy of the long head of the biceps tendon versus continuous radiofrequency ablation of the suprascapular nerve. Changes in shoulder mobility limitations following the two procedures will also be compared using the Constant-Murley score, which assesses shoulder function.

The Effect of Pain Management Education Program on Pain Management Self-Efficacy Among Nurses Caring for Palliative Care Patients: A Quasi-Experimental Study

The goal of this quasi-experimental research designed as a single-group pre-test post-test model is to evaluate the effect of an educational intervention aimed at improving the pain management self-efficacy of nurses providing care to palliative patients on their pain management self-efficacy. The main question it aims to answer is "Does pain management training given to nurses caring for palliative patients improve pain management self-efficacy?". The study sample consisted of nurses providing care to palliative patients. Participants will receive training on "Pain Management in Palliative Care Patients" prepared by the researchers. The training will be given online via Zoom by Nurse Beste Aykaç Özbir, one of the researchers. The training will consist of 4 separate 50-minute sessions with 10-minute breaks, totaling 4 hours over one day.

Analgesic Efficacy of Ultrasound-Guided Deep Iliacus Plane Block in Patients Undergoing Hip Fracture Surgery

Hip fracture surgery is commonly associated with moderate to severe postoperative pain, which may delay mobilization and increase the need for opioid analgesics. The deep iliacus plane block is a recently described ultrasound-guided regional anesthesia technique designed to provide analgesia by allowing local anesthetic spread toward the femoral nerve, lateral femoral cutaneous nerve, and articular branches supplying the hip. This prospective, randomized, double-blind, sham-controlled clinical trial will evaluate the analgesic efficacy of the deep iliacus plane block in adult patients undergoing hip fracture surgery under spinal anesthesia. After surgery, participants will be randomly assigned to receive either an ultrasound-guided deep iliacus plane block with local anesthetic or a sham block with normal saline. All participants will receive standardized multimodal postoperative analgesia, including patient-controlled analgesia. The primary objective is to determine whether the deep iliacus plane block reduces postoperative opioid consumption during the first 24 hours after surgery. Postoperative pain scores, rescue analgesic requirements, sensory distribution, motor block, nausea and vomiting, quality of recovery, patient satisfaction, and block-related complications will also be evaluated.

Virtual Reality Therapy to Improve Arthroplasty Outcomes

Virtual reality (VR) has recently emerged as a non-medication-based method to manage anxiety. The patient wears a VR headset and is offered an immersive environment with hypnotic components with sound and imagery in a 3D environment. VR creates an immersive 3D environment and diverts attention away from worrying thoughts (anxiety) and pain and has been found useful to manage minor procedural pain and related anxiety. This is a pilot feasibility trial to evaluate the effectiveness of VR in improving patient related outcomes (PROM) after joint replacement surgery.

Comparison of Analgesic Effects of ACB Versus ACB Combined With BiFeS Block in ACL Reconstruction Surgery

Anterior cruciate ligament (ACL) reconstruction is commonly associated with moderate to severe postoperative pain, particularly during the early postoperative period and rehabilitation. Effective postoperative analgesia is important to facilitate early mobilization, improve patient comfort, and reduce opioid consumption and opioid-related adverse effects. Adductor canal block (ACB) is commonly used as part of multimodal analgesia for knee surgery because it provides analgesia while largely preserving quadriceps motor function. However, ACB primarily targets the anteromedial aspect of the knee and may provide limited analgesia for pain arising from the posterior and posterolateral knee. The biceps femoris short head (BiFeS) block is a motor-sparing fascial plane block targeting sensory contributions to the posterolateral knee region. Combining BiFeS block with ACB may therefore provide more comprehensive analgesia than ACB alone. This randomized study aims to compare the postoperative analgesic efficacy of adductor canal block alone with adductor canal block combined with BiFeS block in patients undergoing anterior cruciate ligament reconstruction surgery.

The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life. Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose. This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.

The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures

The goal of this clinical trial is to demonstrate the non-inferiority of standardized breathing control exercises on perceived pain during rheumatological injections procedures compared to standard care consisting of the addition of a local anesthetic. The study population will consist of patients scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection. The main question it aims to answer is: * Non-inferiority of breathing exercises compared to the addition of local anesthetic on pain and anxiety experienced during an infiltration procedure. * Correlation between the reduction in pain and anxiety experienced during a procedure and the cardiac coherence score obtained. Researchers will compare the anesthesia group (Arm A), which will receive local anesthesia with 5 cc of lidocaine before the infiltration procedure to the breathing group (Arm B), which will receive instructions before the injection procedure on how to perform 5-minute breathing cycles to facilitate the achievement of cardiac coherence to see if the pain perceived in Arm B is not greater than the pain perceived in Arm A. Participants will be kept blind to their randomization group. Arm A (anesthesia) will receive SHAM breathing exercises, while Arm B (breathing) will receive a placebo injection of anesthetic.

The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis

Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.

The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial

Prostate biopsy is the key examination for the histological diagnosis of prostate cancer. This procedure can be performed via the transrectal (TR) or transperineal (TP) approach. Current Guidelines recommend the transperineal route because it is associated with fewer infectious complications compared to the transrectal approach. However, when the same type of anesthesia is used, the transperineal approach is more painful. Several strategies have been developed to improve pain management during TR biopsy. Some studies have shown that allowing patients to listen to music during the procedure can reduce perceived pain and stress. However, this effect has never been investigated in TP biopsies, which are now the gold standard and generally more painful than TR biopsies. Primary Objective: To evaluate the reduction in pain levels in patients undergoing transperineal prostate biopsy with the aid of music compared to patients undergoing the same procedure without music. Secondary Objectives: To evaluate the reduction in stress levels related to the procedure in patients undergoing transperineal prostate biopsy with music compared to those without music. To evaluate the reduction in the use of painkillers and sedatives during the procedure in patients undergoing transperineal biopsy with music compared to those without. To assess pain management and procedure tolerability in both groups.

Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

The goal of this clinical trial is to see whether a combined distal femoral nerve block improves pain relief after total knee replacement in adults having planned surgery. The main questions it aims to answer are: * Does the combined distal femoral nerve block reduce the amount of opioid needed in the post-anesthesia recovery room? * Does it preserve quadriceps muscle strength while improving postoperative pain control? Researchers will compare the combined distal femoral nerve block to a saphenous nerve block alone to see if the combined block provides better analgesia without reducing leg strength. Participants will: * Receive either the combined distal femoral nerve block or the saphenous nerve block alone before surgery. * Also receive standard multimodal pain management, including anesthesia, surgical site infiltration, and postoperative pain medications. * Be assessed for pain, opioid use, nausea and vomiting, quadriceps strength, time to first standing, hospital stay length, and patient satisfaction from surgery until discharge.

Comfort Communication Model Intervention for Burn Pain and Pain Anxiety

This single-center, randomized controlled trial will evaluate the effect of a nursing intervention based on the COMFORT Communication Model on procedural pain and burn-specific pain anxiety in adult outpatient burn patients undergoing routine dressing changes at the Adult Burn Center Outpatient Unit of Ankara Bilkent City Hospital. Burn dressing changes are frequently perceived as one of the most painful non-surgical procedures, and repeated exposure to wound care may contribute to anticipatory anxiety and stress, potentially creating a reinforcing cycle in which anxiety amplifies pain and pain increases anxiety. In outpatient burn care, effective nurse-patient communication may play a critical role in improving comfort, supporting coping, and enhancing engagement in ongoing treatment. Eligible participants will be adults aged 18 years and older with second- or third-degree burns who have experienced at least three prior dressing changes, can communicate in Turkish, and have no major hearing or cognitive impairment or comorbid psychiatric/neurological condition that would prevent understanding of the study procedures. Participants who request withdrawal, require hospitalization during follow-up, or miss two consecutive intervention sessions will be withdrawn from the study. The required minimum sample size was estimated as 62 patients (31 per group) based on power analysis (effect size f=0.30; 80% power). After providing written and verbal informed consent, participants will be randomly assigned (simple randomization using Random Allocation Software) to either the COMFORT-based communication intervention group or the usual care control group. Data will be collected face-to-face in a quiet and private environment during dressing visits. At the initial visit, participants in both groups will complete a sociodemographic and burn-related information form and baseline assessments. Pain intensity will be evaluated using a Verbal Rating Scale and a Numeric Rating Scale, and pain anxiety will be assessed using the Burn-Specific Pain Anxiety Scale; perceived stress will also be measured. The intervention will be delivered by a wound care nurse during three consecutive dressing sessions. Each session is structured to last approximately 10 minutes and uses specific components of the COMFORT Communication Model tailored to the dressing-change context. In Session 1, the focus is on establishing trust, providing clear information, and supporting patient control through Connection/Communication, Orientation and opportunity, and Relating strategies (e.g., explaining the procedure step-by-step, checking understanding, offering supportive options, and inviting the patient to signal if they want pauses). In Session 2, the focus shifts to creating space for emotions and strengthening supportive openings using Mindful communication, Openings, and Family components (e.g., exploring how the prior session felt, inviting expression of concerns, and identifying supportive persons). In Session 3, communication emphasizes personalization, meaning-making, and teamwork by integrating Relating, Team, and Meaning-focused prompts (e.g., reflecting on what was most helpful, supporting adaptive coping, and, if appropriate, facilitating communication with the clinical team). Throughout all sessions, routine wound care will continue as standard practice in both groups. Outcomes will be assessed repeatedly across the three dressing sessions. Pain and pain anxiety will be assessed before each dressing, and follow-up assessments will be repeated approximately 30 minutes after the dressing procedure. The primary objective is to determine whether COMFORT model-based nursing communication reduces procedural pain intensity and burn-specific pain anxiety compared with usual care during outpatient dressing changes. A secondary objective is to evaluate whether the intervention reduces perceived stress across sessions. Statistical analyses will include appropriate descriptive and repeated-measures comparisons to examine group differences over time.

The Effect of Buzzy® and a Stress Ball on Reducing Pain and Fear During Peripheral Intravenous Cannulation in Children

This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. It seeks to answer whether one method is more effective than the other in reducing children's pain and fear during the procedure.

The Effects of TFPB on Opioid Consumption in Patients Undergoing HLDN

This study aims to evaluate whether a regional anesthesia technique called the transversalis fascia plane block (TFPB) can improve pain control after hand-assisted laparoscopic donor nephrectomy (HALDN), a minimally invasive surgery performed in living kidney donors. Although HALDN is less invasive than open surgery, patients often experience significant pain after the operation, mainly due to the surgical incisions in the lower abdomen and trocar entry sites. Poorly controlled pain can delay recovery and increase the need for opioid pain medications, which may cause side effects such as nausea, vomiting, itching, and sedation. The transversalis fascia plane block is an ultrasound-guided regional anesthesia technique in which a local anesthetic is injected into a specific tissue plane in the lower abdominal wall. This injection temporarily blocks pain signals from nerves supplying the lower abdomen and groin area. The technique has been shown to reduce pain and opioid use after various lower abdominal surgeries and is considered minimally invasive and safe when performed under ultrasound guidance. In this study, patients undergoing HALDN will be randomly assigned to one of two groups. One group will receive standard general anesthesia only, while the other group will receive general anesthesia plus a transversalis fascia plane block using a local anesthetic (bupivacaine). All patients will receive the same standard pain treatment after surgery, including paracetamol and patient-controlled morphine. The main goal of the study is to compare the amount of opioid pain medication used during the first 24 hours after surgery between the two groups. Secondary outcomes include pain scores measured using the Numeric Rating Scale (NRS), the frequency of opioid-related side effects, and patient satisfaction with pain control. The results of this study may help determine whether adding the transversalis fascia plane block to standard anesthesia can provide better pain relief, reduce opioid consumption, and improve comfort and recovery in living kidney donors.

QLESP Block Versus PENG+LFCN Block for Total Hip Arthroplasty

Total hip arthroplasty (THA) is a common surgery to replace damaged hip joints, but many patients experience significant pain after surgery, which can delay recovery and increase the need for strong pain medications (opioids). Nerve blocks are a technique where anesthetic medication is injected near specific nerves to reduce pain. This study compares two different ultrasound-guided nerve block techniques for pain control after THA: the QLESP block (a newer technique that targets two areas with a single injection) and the PENG block combined with the LFCN block (a currently used technique that targets nerves around the hip joint and the outer thigh). Participants in this study will be randomly assigned (like a coin flip) to receive either the QLESP block or the PENG+LFCN block after surgery. The study aims to determine which nerve block provides better pain relief and reduces the need for opioid pain medications in the first 24 hours after surgery. Pain scores, recovery of leg movement, time to first walk, length of hospital stay, and any side effects will also be compared between the two groups.

Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery

This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine. Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA). The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery. There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.

Ketorolac at Lower Doses for Analgesic Pain Control in ICU: A Pilot Feasibility Study

Opiates are commonly used to control pain in critically ill patients in the ICU. However, increased rates of opiate use in hospital may lead to increased prescription-based opiate dependence after leaving the ICU. This may contribute to the ongoing opiate epidemic across the world. Other medications that can reduce pain, like non-steroidal anti-inflammatory drugs (NSAIDs), are being studied in critically ill patients. These drugs block the enzyme, cyclooxygenases (COX), which causes inflammation in the body. Blocking these enzymes can decrease pain, fever, and inflammation. Traditionally, NSAIDs are not commonly used in critically ill patients due to the perceived risk of gastrointestinal (GI) bleeding and acute kidney injury (AKI). However, many critically ill patients are already receiving medications and treatments to prevent GI bleeding and AKI and are closely monitored so these medications may be useful in reducing pain for these patients. The purpose of this study is to see whether NSAIDs can be used safely in critically ill patients to reduce the dose of opiates required for pain control. This is a pilot study or a feasibility study, which is not expected to answer the question definitively. Its main purpose is to determine if NSAIDs could reduce the use of opiates in critically ill patients while in the ICU. The data collected in this study may be used in a larger study in the future.

Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. The main questions it aims to answer are: Does the analysis of blood pressure, heart rate, and brain wave activity indicate the patient's response to skull pin fixation pain during brain surgery? How do the methods used to reduce skull pin fixation pain in brain surgeries affect narcotic opioid consumption? The researchers will monitor the patients' response to skull pin fixation pain during surgery through the analysis of brain wave activity.

QoR40 Between Intercostal Block and Intercostal Block and Serratus Plane Catheter During VATS

Video assisted thoracic surgery (VATS) has emerged as standard of care for majority of thoracic surgeries. It is less invasive compared to thoracotomy and is associated with improved perioperative outcomes \[1-3\]. Good perioperative analgesia after thoracic surgery will enable pulmonary toilet, early chest physiotherapy and mobilisation, \[4,5,6\]. Thirty-day hospital visits and hospital readmissions at London Health Sciences Centre (LHSC) is around 21% and 9% respectively \[7\]. One of the top five determinant for hospital visit and readmission in 30 days, was persistent post operative pain \[7\]. Several options to analgesia are available for patients undergoing VATS procedure. Systemic opioid based multimodal analgesia, central neuraxial blocks like thoracic epidural and peripheral nerve blocks are different available options, and their practise varies across institution \[4,8,9\]. Thoracic epidural or paravertebral blocks can be challenging to perform with high failure rates \[10-12\]. Fascial plane blocks (SAB; ESP) are in vogue in the present era \[13-16\]. They are easy to perform and do not require similar dexterity as needed to perform thoracic epidural or paravertebral blocks. They have minimal side effects and provide the options for continuous infusion for prolonged analgesia. They have become an effective part of multimodal analgesia and have established their roles in ERAS (enhanced recovery after surgery) protocol for VATS procedures. SAB has become a common practise at our institution with proved clinical efficacy. Perioperative Surgical Home is a patient centric team-based approach to improve patient's experiences in the perioperative period and thus improve healthcare \[17\]. Quality of Recovery (QoR) is a key determinant to perioperative surgical home and can be measured using the QoR 40 score \[18\]. This is a well validated score with a minimal important clinical difference (MICD) of 6.3 \[19\]. Quality of recovery combines five dimensions of health: patient support, comfort, emotions, physical independence and pain to achieve a single patient outcome - improved patient care \[18\]. The investigators hypothesize the that patients undergoing VATS lung resections using a combination of intercostal nerve block plus continuous SAB catheter infusion of local anesthetics will have a 20% increase in their QoR-40 score 24hour after the surgery compared to a single shot intercostal nerve block.

Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment

This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.

Comparison of the Efficacy of Ultrasound-guided Supra-inguinal Fascia Iliaca and Lumbar Erector Spina Plan Block in Hip Fractures

The aim of our study was to evaluate the efficacy and patient satisfaction level of SI-FIB and lumbar ESPB for positioning and postoperative analgesia during spinal anesthesia in patients undergoing hip fracture surgery.

Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection

The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.

Studying Warmed Lidocaine for Increased Analgesic Effect During Intravitreal Injections

Investigating whether warmed lidocaine increases analgesic effect for intravitreal injections

The Effects of Two Methods Applied on Pain and Fear During Phlebotomy in Children

Objective: This study aimed to evaluate the effects of using an externally vibrating dolphin-shaped Dolphin massage device and digital storytelling via tablet on pain and fear in children aged 3 to 6 years during blood collection. Method: This randomized controlled trial was conducted with 105 children aged 3-6 years who visited the pediatric blood collection unit of a training and research hospital between June 2024 and June 2025. This study used the CONSORT checklist. After obtaining consent from the child and parent, the children (n=105) were assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)) using block randomization. The children's pain and fear scores were assessed after phlebotomy by their parents, the nurse performing the phlebotomy, and the researcher using the Wong-Baker Pain Scale and the Child Fear Scale. The phlebotomy procedure was performed by a single nurse.