Clinical Research Directory

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

Comparing the Effect of Scenario-Based Teaching Method to Conventional Method on Medical Students' Knowledge and Satisfaction in Psychiatry Interns

Traditional medical education methods, which rely heavily on lectures and textbook study, have come under criticism for their inability to foster the critical thinking, clinical reasoning, and practical skills required to manage complex psychiatric cases. The static nature of these methods fails to replicate the dynamic and unpredictable scenarios of real-world clinical practice, thereby hindering students' preparedness for the multifaceted challenges of psychiatric care However, across various disciplines-particularly in medical and allied health sciences-new methods emphasizing active student participation have gained prominence. One such modern approach in health sciences education is scenario-based learning; grounded in situated learning theory, it brings students closer to the professional realities of their field. This method utilizes scenarios as tools for teaching and learning, enabling students to learn from real-world experiences and apply them in practice.

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.

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 more systematic data collection and timely clinical assessment. 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 may be possible to support patient monitoring and clinical workflow, particularly 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, owned by Item Oxygen Srl, which purchased the platform from CO-ROBOTICS S.R.L. through the PON SI-ROBOTICS project. The system is designed to support the monitoring of patients' clinical conditions by integrating physiological and clinical data and identifying predefined signs of potential deterioration. It supports healthcare professionals by providing clinical information and automated alerts that prompt healthcare-professional review. The study is a low-intensity, non-randomized controlled pilot feasibility interventional study conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and allocated to one of 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 evaluated using predefined feasibility and technical measures together with validated assessment tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Indicator Tool (HSE). The specific role and interpretation of these measures are defined in the study protocol. The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with the acquisition and integration of physiological and clinical data through a dedicated software architecture. The platform incorporates 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 risk assessment in patients with suspected infection, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury. The present pilot study is intended to characterize the feasibility of integrating the MOVER-L/ROB.IN.CARE system into routine neurorehabilitation practice, including its technical performance, usability, safety, acceptability, and integration into the clinical workflow. The findings are intended to identify implementation requirements and sources of variability and to inform the design of subsequent adequately powered studies evaluating the clinical impact of robotic monitoring.

The Effect of Audio-hypnosis on the Academic Performance of Nursing Students.

Exam stress significantly affects the mental health and cognitive functions of nursing students. Audio-hypnosis offers a practical and low-cost intervention. Objective: To evaluate the effect of a single audio-hypnosis session on perceived stress, heart rate, and academic results. Methods: A pilot randomized trial will be conducted with 20 second-year students at ISPITS Safi, divided into an intervention group and a control group (n=10 each). Anxiety (VAS), heart rate (HR), and exam grades were analyzed.

Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

Comparing Instructor-led Versus Blended Cardiopulmonary Resuscitation Training Among Nursing Students

Objectives of the Study The current study aimed to investigate how individual and team personality traits, academic motivation, and academic procrastination predict CPR training outcomes at individual and team levels, and to what extent these associations vary across different CPR training modalities (instructor-led versus blended). Material and methods Design This study employed an experimental, posttest-only control group design. Subjects The target population comprised undergraduate nursing students enrolled in the BSN program. The inclusion criteria were determined as follows: (1) third- and fourth-year students, (2) they had already completed foundational coursework. On the other hand, the exclusion criteria were: (1) students enrolled in the program through bridging tracks, and (2) students who had completed the comprehensive clinical course. Potential participants were randomly selected from eligible nursing students listed in academic records, screened for inclusion criteria, and invited via email. A total of 133 nursing students were enrolled and randomly assigned to one of two study groups. They were then divided into groups of 6 using block randomization to balance group sizes. Because the interventions differed in content and delivery, blinding of students and instructors was not possible. The required sample size was calculated through an independent samples t-test aimed at detecting a moderate effect size (Cohen's d = 0.5) between the two training groups, with a statistical power of 0.80 and a significance level of 0.05. Based on that, a minimum of 63 students per group was required to ensure adequate power to detect statistically significant differences in the measured outcomes. Randomization Participants were selected using a random sampling technique following the acquisition of a complete list of eligible nursing students from official academic records. Based on the predefined inclusion and exclusion criteria, a filtered list of potential participants was generated. From this list, students were randomly selected and invited to participate through a recruitment link sent to their email addresses. Those who filled out the link were screened again for eligibility, and then the researchers contacted those who met the criteria to notify them of their enrollment. Recruited participants were then assigned to one of the two study groups, ensuring an unbiased and systematic approach to participant recruitment (Figure 1). Randomization utilized stratified randomization (to ensure that the distribution of both nursing schools is similar across treatment groups) and block randomization (to ensure that the number of participants assigned to each treatment group remains roughly equal throughout the trial). Due to the varying educational materials and delivery methods, it was not possible to blind or conceal the allocation to either students or instructors. Interventions All CPR training sessions were conducted over nine weeks (May - July 2025) at the Life Support Center at the private university, which is accredited by the American Heart Association (AHA) and equipped with high-fidelity manikins and advanced audiovisual technology. Following participant selection, students were randomly assigned to one of two intervention groups, each receiving a different CPR training modality. Both training methods were based on the most recent guidelines from the AHA and delivered by certified instructors to ensure consistency and quality of instruction (American Heart Association \[AHA\], 2020). Each participant received an official invitation via email, which included a cover letter, details of the training schedule, course materials, and an informed consent form. To reduce potential external influences, both groups received their respective training at the same time. Upon completion of the training, participants were immediately asked to complete the postest self-reported questionnaires through Google Forms, with all items set as mandatory. Students were instructed to complete the surveys independently and were assured of the confidentiality and anonymity of their responses. Intervention and Data Collection All CPR training sessions were conducted over nine weeks (May - July 2025) at the Life Support Center at the private university, which is accredited by the American Heart Association (AHA) and equipped with high-fidelity manikins and advanced audiovisual technology, providing a realistic and interactive environment to support hands-on, experiential learning under standardized conditions. Following participant selection, students were randomly assigned to one of two intervention groups, each receiving a different CPR training modality. Both training methods were based on the most recent AHA guidelines and delivered by certified instructors to ensure consistency and quality of instruction. participants were assessed at day of the course and after 3 months.

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.

Use of Hand Extension Rubber During Intravenous Catheter Placement

The study aims to investigate the effect of a hand extension rubber used in patients with peripheral intravenous catheters on pain, anxiety, and satisfaction.

Effect of Short Film Video and Video-Based Education on Fear, Pain, and Satisfaction of Children Undergoing Day Surgery

It is aimed to investigate the effect of introducing the operating room environment with an informative video to pediatric patients aged 7-12 in the preoperative period in day surgery on pain, fear, and patient and parent satisfaction. In line with this purpose, an answer was sought to the question "How did the different education programs given to children who will undergo day surgery have an effect on fear, pain and satisfaction?" It will be conducted in a single center, parallel group, randomized controlled experimental design. The research will be carried out between December 2022 and October 2023 and it is planned to continue for 12 months. The population of the research will be children between the ages of 7-12 who will undergo a day surgery at Tarsus State Hospital, and the sample will be 90 children who meet the criteria for inclusion in the research. Considering that there may be case losses, a total of 90 children (1st experimental group \[watched video training\]:30 children, 2nd experimental group \[provided planned training\]: 30 children, control group: 30 children) will be included in the sample group. In the collection of research data; Introductory Information Form, Numerical Pain Scale, Child Fear Scale, Vital Signs Follow-up Form (Appendix 4) will be used. The application will be started after the approval of the ethics committee and the written permission of the institution for the research. Statistical package program (SPSS 20) will be used in the analysis of the research data.

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 an independent, certified web-based randomisation service. Approximately 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 of this study is a composite patient-reported procedural experience endpoint, assessed immediately after the procedure. The primary analytical component of this composite endpoint is procedural anxiety, measured using a 10-point Visual Analogue Scale for Anxiety (VAS-A). The main statistical analysis will compare changes in VAS-A scores between the intervention group and the control group. The additional dimensions of the composite endpoint, patient-reported comfort, satisfaction and procedural tolerability, are collected concurrently and are not aggregated into a single score. These dimensions are analysed separately and interpreted jointly with procedural anxiety in order to provide an overall assessment of the patient's procedural experience. Secondary outcomes include: 1) procedural pain, assessed using a 10-point Visual Analogue Scale (VAS); 2) physiological parameters, including heart rate and arterial blood pressure; 3) procedural characteristics, such as procedure duration and number of device insertion attempts; 4) qualitative assessment of patients' perceptions and lived experiences of the procedure, analysed using Van Kaam's phenomenological method18. 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 aim of this study is to evaluate the effect of an immersive virtual reality intervention on the overall procedural experience of adult oncology patients undergoing PICC and PICC-PORT placement, with patient experience conceived as a primary dimension of quality of care.

Effectiveness of Game-Based Learning in Pain Management Education for Nursing Students

Aim: To evaluate the effectiveness of game-based learning on undergraduate nursing students' pain management knowledge, learning motivation, and educational satisfaction. Background: Pain management is a core nursing competency. Although game-based learning is increasingly used in nursing education, evidence regarding its effectiveness in pain management education remains limited. Design: Single-blind randomized controlled trial. Methods: Undergraduate nursing students were randomly assigned to either a game-based learning or traditional education group. Pain management knowledge, learning motivation, and educational satisfaction were assessed immediately after the intervention and at a two-week follow-up.

Virtual White Boards for Patient Satisfaction

Communication with patients on their clinical status is important in delivering care in the emergency department. During times of high volume or complex patients, there may be lapses in communicating with patients about their hospital course or plans of action. These miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized in-person interaction with patients in order to conserve personal protective equipment and decrease the risk of disease transmission. This study utilizes a virtual white board to deliver updates to patients about the status of their emergency department stay.

Inflatable Penile Prostheses : Which Patients Can Correctly Use the Scrotal Pump ?

Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Nevertheless, a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options. Since the first implantation of foreign material intracarvernosally in 1966 by Beheri, multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance. First introduced in 1973 by Scott et al., inflatable prosthesis provides now high general satisfaction rates (69-94%), better than in malleable prostheses, except for few authors. In addition to changes in materials and construction, the two main manufacturers of IPP, Boston scientific AMS (Marlborough, MA, USA) and Coloplast (Minneapolis, MN, USA), modernized the pump mechanism of their devices. Since the introduction of AMS IPP, three main pump formats have been used : the standard pump has been replaced in 2004 by the " Tactile " pump and then the " Momentary Squeeze " (MS) pump in 2006, smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation. Coloplast also replaced in 2008 their " Genesis " pump by a " One Touch Release " (OTR) pump, and finally in 2014 by the current " Touch " pump, smaller, and presenting a biconcave deflation button, easier to find. Despite all technological advances, appropriate pre-operative counselling and careful post-operative teachning, a significant part of patients has still difficulties to handle the pump and thus, does not use their IPP, regardless of any material malfunction. That situation obviously leads to patient's dissatisfaction and highlights the operating risks of a useless surgical procedure. The purposes of this study were:to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation, then to show a correlation between easy handling and post-operative satisfaction. And last but not least, to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling. That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction.

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.

Conscious Sedation for Transcatheter Aortic Valve Implantation

Aortic valve stenosis is the heart valve disease with the highest prevalence among the elderly, and may lead to heart failure. Until recently, the only definitive treatment was surgical replacement (SAVR). However, the increased risk associated with the surgical procedure excluded patients with multiple co-morbidities. As the population is aging and more and more patients may present with aortic stenosis, the need of a less invasive approach has emerged. Transcatheter Aortic Valve Replacement (TAVR) offered an alternative therapy for these high risk patients. This new method has seen worldwide acceptance, has been proven very beneficial for these patients, and therefore its indications have been expanded to intermediate risk patients, as well. Until recently, general anesthesia was the primary anesthetic technique for TAVR, but conscious sedation or monitored anesthesia care (MAC) is gaining more and more popularity lately. Our knowledge regarding the comparison between general anesthesia and MAC in TAVR procedures is derived mainly from observational studies and few randomized trials. MAC seems to be associated with less inotropic drug usage, shorter procedural times, shorter intensive care unit (ICU) and hospital length of stay. However, according to published data, there were no differences in 30-day mortality and complications between these two techniques. Even less are known about the most suitable anesthetic agent for MAC during TAVR. Many drugs have been used, with propofol and dexmedetomidine being the most popular. However, there are only few comparative studies and their results are not conclusive. This study compares MAC under propofol and MAC under dexmedetomidine for TAVR in order to examine which method of conscious sedation comes with more beneficial postoperative outcomes for the patients.

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.

Pre-anesthetic Teleconsultations During Pregnancy

Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.

The Effect of Podcast Use on Waste Management on Nursing Students'

This study will be conducted to measure the effect of podcast use on waste management on nursing students' knowledge and satisfaction. The study was planned as a randomized controlled pretest-posttest study. The study sample will consist of 100 first-year students (50: Control; 50: Intervention) enrolled in the 2025-2026 Spring semester at Necmettin Erbakan University Faculty of Nursing. The study is planned to be conducted in February-March 2026 during the Spring semester of the 2025-2026 academic year. Data will be collected from first-year nursing students in a face-to-face classroom setting. Data will be collected using a "Personal Information Form," a "Waste Management Knowledge Test," and a "Satisfaction with Teaching Methods Survey." The data obtained from the study will be analyzed in a computer environment using SPSS (Statistical Package for the Social Sciences) version 22.0 (IBM Corp., Armonk, NY, USA). Data will be evaluated using descriptive statistics. The Kolmogorov-Smirnov test will be used to assess data for normal distribution. If data are normally distributed, the Independent Samples t-test will be used to compare two independent groups, the Paired Samples t-test will be used to compare two dependent groups, and the Pearson correlation will be used to compare the relationships between scales. If data are not normally distributed, the Mann-Whitney U test will be used to compare two groups.

Satisfaction and Quality of Life Among Prosthetic Users in Gaza Governorate ,

Prosthetic devices help amputees regain mobility and improve appearance. When patients are satisfied with their prosthesis, they are more likely to use it consistently, leading to better rehabilitation outcomes. In Gaza, the 2023 Gaza War caused a rise in traumatic amputations and limited access to healthcare and prosthetic services. This makes rehabilitation more difficult, affecting both physical and mental health. Research on patient satisfaction and quality of life (QoL) among lower limb prosthetic users in Gaza is limited. This study evaluates satisfaction and QoL in this population, aiming to provide information to improve prosthetic care and guide interventions tailored to local needs.

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.

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.

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