Clinical Research Directory

Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion

The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.

Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units

Frailty is not related exclusively to age, but represents a state of increased biological and clinical vulnerability characterized by reduced functional reserve and greater susceptibility to adverse events, even in response to minor stress factors. In patients with complex conditions, such as severe acquired brain injuries, early detection and prompt treatment of clinical deterioration are essential to reduce the risk of acute readmission, complications, and in-hospital mortality. Many of these events are potentially predictable and preventable, given the presence of appropriate monitoring systems. Advanced care models, including early warning systems, have been developed to support healthcare professionals in identifying patients at risk by detecting significant changes in physiological parameters. In recent years, technological innovations-particularly in the fields of robotics and telemedicine-have created new opportunities to enhance clinical monitoring, enabling continuous data collection and more timely, proactive interventions. Social assistive robots are emerging as promising tools in healthcare settings. These systems can support clinicians and nurses in routine monitoring activities, help reduce workload, and facilitate more efficient and personalized care. By integrating robotic assistance with digital health platforms, it is possible to improve the quality and responsiveness of patient management, especially in high-complexity environments such as neurorehabilitation units. This study focuses on the use of an innovative robotic telemedicine system based on the integration of the MOVER-L prototype with the ROB.IN.CARE platform, promoted by Item Oxygen (Bari, Italy). The system is designed to continuously monitor patients' clinical conditions, collecting vital parameters and identifying early signs of deterioration. It supports healthcare professionals by providing real-time data and alerts, enabling earlier and more targeted interventions. The study is a low-intensity interventional clinical trial conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and divided into two groups: a control group receiving standard care and an experimental group monitored using the robotic system in addition to usual care. The primary objective of the study is to evaluate the feasibility, usability, safety, and reliability of this robotic telemedicine solution in a real clinical setting. In addition, the study assesses its acceptability among both patients and healthcare professionals. These aspects are measured using validated tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Scale (HSE), to understand the impact of the technology on user experience and workload. The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with continuous monitoring of vital signs and advanced software architecture. The platform incorporates predictive algorithms designed to stratify clinical risk and assess patient severity. It utilizes established clinical scoring systems, such as the Modified Early Warning Score (MEWS) for early detection of clinical deterioration, the quick Sequential Organ Failure Assessment (qSOFA) for sepsis risk evaluation, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury. By enabling early identification of clinical worsening, the system aims to improve the timeliness and effectiveness of healthcare interventions, optimize clinical workflow, and reduce the risk of adverse events and complications. Ultimately, this study explores whether robotic telemedicine can represent a safe, feasible, and valuable tool to enhance the management of fragile patients in neurorehabilitation settings.

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants

The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.

Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients

Virtual reality (VR) has increasingly been explored in medical settings as a non-pharmacological intervention for the management of pain and anxiety associated with invasive procedures. By providing immersive and interactive environments, VR is thought to modulate both sensory and emotional components of pain through mechanisms involving focused attention, cognitive engagement, and altered perception, which share similarities with hypnosis-based approaches. Evidence from previous studies, initially conducted mainly in paediatric populations and more recently extended to adults, suggests that VR may effectively reduce procedural anxiety and pain without increasing procedural duration or clinical workload. Oncology patients undergoing the placement of vascular access devices, such as peripherally inserted central catheters (PICC) and PICC-PORTs, frequently experience procedural distress, including anxiety and discomfort, related to the invasive nature of the intervention. Procedural anxiety may negatively influence patient experience, cooperation, and overall tolerance of the procedure, potentially increasing the need for pharmacological anxiolytic or analgesic support. Identifying effective, safe, and easily applicable non-pharmacological strategies to reduce distress during these procedures represents a relevant clinical goal in oncology care. The present study aims to evaluate the effectiveness of virtual reality delivered via a head-mounted display in reducing patient-reported anxiety and pain in adult oncology patients undergoing PICC or PICC-PORT insertion. This study is designed as a prospective, interventional, randomised controlled trial with a 1:1 allocation ratio using a random number generator within REDCap. A total of 120 patients will be enrolled at a single centre, the Istituto Oncologico Veneto (IRCCS), and randomly assigned to one of two study arms. Participants allocated to the intervention arm will receive VR in addition to the standard of care (VR + SOC) throughout the vascular access placement procedure, while participants in the control arm will undergo the standard procedure alone (SOC). The VR intervention will be delivered using HypnoVR, a software-based medical device classified as Class I, non-sterile, and compliant with Regulation (EU) 2017/745 on Medical Devices. The intervention will be administered via a head-mounted display with audiovisual content designed to promote relaxation, focused attention, and emotional regulation during the procedure. The primary outcome measure is the reduction of anxiety levels at the end of the procedure, assessed using the validated Visual Analogue Scale for Anxiety (VAS-A). Secondary outcomes include patient-reported pain, qualitative assessment of procedural comfort, and perceived ease of procedural management as reported by healthcare staff. Data collection will include both quantitative and qualitative measures within a mixed-methods framework. Quantitative data will be analysed using descriptive and inferential statistical methods to assess differences between study groups, while qualitative data derived from semi-structured interviews will be analysed using the Van Kaam phenomenological method to explore patients' lived experiences. The study aims to provide evidence on the role of virtual reality as a supportive, non-pharmacological option for anxiety and pain management during vascular access placement in oncology patients.

The Effect of Virtual Reality Distraction on Pain and Discomfort Associated With Bitewing Radiographs in Pediatric Patients

This study will be conducted at King Abdulaziz University Dental Hospital (KAUDH). Ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry at King Abdulaziz University (32-03-25). Inclusion criteria will include healthy and cooperative children aged 4 to 12 years who are referred to the radiology department for two-bitewing radiographs. Children with a history of epilepsy or anxiety disorder will be excluded. The study's purpose, risks, benefits, and limitations will be explained to the parents or guardians of eligible children by trained dental interns. Those who agree to participate will be asked to sign an Arabic consent form before their involvement. Additionally, an assent form will be obtained from children aged seven and older. Subjects' age, gender, previous dental experience, and behavior during previous dental visits, as assessed by Frankl's behavior rating scale , will be recorded, along with whether they own or have prior exposure to a virtual reality device. Only children with cooperative and definitely cooperative behavior will be included. A randomization sequence with an allocation ratio of 1:1 will be generated using computer software and kept with a radiology assistant who is not involved in the study to ensure allocation concealment. Due to the nature of the study, neither the subject nor the radiologist will be blinded to the group allocation. However, the statistician will be blinded to which group each subject will be allocated. Before taking the radiographs, subjects will be asked to select a video from a list of popular cartoon shows or a video of their preference. In the test group, the subjects will wear virtual reality device goggles (LG 360 virtual reality \[VR\] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. In the control group, radiographs will be taken without the use of any distraction device. The sounds of the videos will be played on headphones. All bitewing radiographs will be taken by the same radiologist, following the As Low As Reasonably Achievable (ALARA) protocol and hospital guidelines. The procedure uses either size one or size two bitewing Photostimulable Phosphor digital sensors, along with a film holder and a rectangular collimator. While taking the radiographs, the Tell-Show-Do behavior management technique will be used with all participating children, and they will be recorded with a high-resolution camera. The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the face, legs, activity, cry, and consolability (FLACC) behavioral pain assessment scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain. Additionally, the behavior during the BWS will also be recorded using Frankl's behavior rating scale classification. Training and calibration for the evaluators will involve watching videos of 20 randomly selected children during their dental treatment. A stopwatch will be used to measure the chair time required to take the radiographs. In the test group, the time needed to place the VR device will be included. Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. Finally, the satisfaction with the use of VR during BWS taking will be assessed using a five-point Likert scale, where zero indicates 'not satisfied at all' and 10 means' very satisfied'. Subjects who require repeating any of the BWS will be excluded from the study

Associations of Cranial Outcomes and Parental Expectations and Satisfaction

This study aims to investigate the association between objective cranial morphological changes and parental expectations and satisfaction in infants undergoing treatment with a cranial remolding orthosis (CRO). Infants diagnosed with positional cranial deformities and prescribed CRO treatment will be included. Cranial morphological outcomes will be assessed using standardized cranial measurements obtained before and after the treatment period. Parental treatment expectations will be evaluated prior to the initiation of CRO therapy using the Treatment Expectation Questionnaire (TR.TEX-Q), while parental satisfaction with the device and treatment process will be assessed at the end of treatment using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The primary objective of the study is to examine the relationships between changes in cranial morphology and parental expectations and satisfaction scores. Secondary objectives include exploring the association between baseline expectations and post-treatment satisfaction. The findings are expected to provide insight into how objective treatment outcomes align with family-reported perceptions in cranial remolding orthosis therapy.

Supporting Families in the ICU

The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.

Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department

The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department. The main questions it aims to answer are: * Which sedation and analgesia methods provide the best patient satisfaction and pain relief? * How do different treatment methods affect clinician satisfaction and the occurrence of adverse events? The investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control. Participants will: Be adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures. Receive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care. Report their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.

Virtual Reality-Assisted Intraoperative Sensory Modulation on Postpartum Depression and the Kynurenine Pathway

The research will be conducted as a prospective, observational, and comparative study with 98 pregnant volunteers aged 18-45 at Düzce University Faculty of Medicine. Participants will be divided into a VR group and a control group. Data will be collected using STAI-I, EPDS, NRS scales, and biochemical analyses (tryptophan, kynurenine, etc.). Upon completion, the project is expected to contribute to non-pharmacological approaches and new care protocols for reducing postpartum depression.

A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Impact of Verbal Compared to Structured Information on Patient's Anxiety and Satisfaction Undergoing Uroflowmetry

Background: Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-line investigation for the evaluation of lower urinary tract symptoms. Despite its non-invasive nature, uroflowmetry can provoke anxiety and affect satisfaction, often due to misunderstandings about the procedure. Objective: This randomized control trial aimed to compare the effects of structured versus verbal education on anxiety and satisfaction in patients undergoing uroflowmetry. Methodology: A single-blind, parallel-arm study will include 48 patients, which will be randomized into structured (brochure) and verbal counseling groups. The modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will assess anxiety, while satisfaction will be measured by using a questionnaire adapted from Dogun et al. Descriptive statistics, Chi-square, and independent t-tests will be employed for data analysis in spss 23.

Nutrition in Action: Service-Learning Project

Service-learning methodology (SL) combines training and community processes in a single project where participants are trained while working on real needs of the environment with the aim of improving it. This methodology enhances the professional skills of the students, their personal and competence development, and develops a deeper sense of civic responsibility. The Human Nutrition and Dietetics Degree (ND) of the Faculty of Health and Welfare Sciences (FCSB) of the University of Vic-Central University of Catalonia decided to incorporate this methodology, according to University's training model, with the aim of generating learning situations that allow them to act, reflect and solve problems based on significant learning. We applied SL in the subject of Food Education Strategies designing and implementing a small food education program with 1 contact to detect the needs of the users, and 3 educational sessions. The implementation of the SL is based on the SL guide proposed by the Service Learning Network of Catalan Universities and we make it with 4 local social entities. The teacher responsible for the SL is coordinated with responsibles from entities who act as facilitators, authorizing the collection of data from the people of the entities, recruiting, informing and collecting the willingness to participate from the users. We plan to study the experience of participating in the SL activity in terms of student acquisition of skills and satisfaction of all the parties involved, based on an observational study carried out during 4 academic years (2025-2029). Through convenience sampling, a participation of 65 people is expected (20 students, 40 users, 5 responsible from entities). Data collection plans to compile information on: a.Experience of the SL of the university student body. b. Assessments of the users and responsibles from entities on the impact, quality and satisfaction with the SL activity. c. Proposal for improving the SL activity with the entities using the rubric for self-assessment and improvement of SL projects. Data collection will take place at the end of the activity using the REDCap platform (Research Electronic Data Capture) and the statistic analysis is planned using the SPSS statistical program.

Effects of Shotblocker and Manual Pressure on Pain and Satisfaction

This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method. Research Hypotheses * H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group. * H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group. * H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group. * H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.

Effects of Pilates Ball and Sacral Massage Applications on Labor Pain, Labor Duration and Childbirth Satisfaction

As researchers, we believe that Pilates ball and manual sacral massage applications can be easily and cost-free applied in maternity clinics in our country. For all these reasons, this study was planned as a randomized controlled study to evaluate the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration, and labor satisfaction. The research will be carried out between December 1, 2024 and May 1, 2025 in two public hospitals affiliated with the Gaziantep Provincial Health Directorate. The sample of the research will consist of 35 pregnant women in the Pilates ball group, 35 in the sacral massage group and 35 in the control group, totaling 105 pregnant women who meet the criteria for inclusion in the research. Applications to the intervention groups will be made during the active phase of labor. Personal Information Form, Labor Monitoring Form, Application Monitoring Form to record the number and duration of applications, Visual Analog Scale to assess labor pain, Partograph to assess labor duration and Labor Satisfaction Scale to assess maternal satisfaction will be used in data collection. Data will be analyzed with tests appropriate to normal distribution characteristics in the SPSS 24 package program. At the end of the research, the effects of Pilates ball and sacral massage applications in labor on labor pain, labor duration and labor satisfaction will be evaluated.

Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery. The purpose of the study is: 1. assessment of the level of anxiety experienced by parents before and after thoracic surgery, 2. assessment of risk factors for parents' perioperative anxiety, 3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

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.

Effects of Virtual Reality and Helfer Skin Tap During Vaccination

The aim of this study was to detect and compare the effects of Virtual Reality and Helfer Skin Tap methods on pain, fear, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. The sample was included 138 children in a family health centers aged 13 years who underwent Tetanus-Diphtheria vaccine. The participants were randomly assigned to Virtual Reality, Helfer Skin Tap, and control groups. Each group included 46 children, of whom 23 were female and 23 were male. The State-Trait Anxiety Inventory, Children's Fear Scale and Visual Analog Scale were used to collect the data.

Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students

Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.

Post-c-section Pain Control Satisfaction with Erector Spinae Simple Block Vs Lateral Quadratus Lumborum Block

The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia. The primary outcome is to test whether the type of plane block has an implication on the patients' satisfaction. The secondary outcome is to test the difference between the two approaches on the hospital discharge

The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization

Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.

Pediatric Perioperative Satisfaction Questionnaire

The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women

The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain and Satisfaction Related to First Vaginal Examination in Women: A Randomised Controlled Study

Pessary Satisfaction Criteria for Urogenital Prolapse

Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate. The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.