Clinical Research Directory

Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children

Burn dressing procedures can cause pain, anxiety, and fear in children. Distraction techniques may help children cope with these procedures and improve their comfort. This randomized controlled trial will evaluate whether watching short videos before and during burn dressing reduces anxiety, pain, and fear in children aged 5 to 12 years. Eligible children scheduled for elective burn dressing will be randomly assigned to either a short-video distraction group or a control group. Children in the short-video distraction group will watch age-appropriate short videos of their choice on a smartphone or tablet for approximately 20 minutes before the procedure, and video viewing will continue during the burn dressing procedure when feasible. Children in the control group will receive routine care without an additional video-based distraction intervention. Anxiety, pain, and fear will be assessed at predefined time points before and during the procedure using standardized assessment tools. The primary objective is to determine whether short-video distraction reduces peri-procedural anxiety compared with routine care.

Evaluating Operation Calm With Children, Parents, and Clinicians

Operation Calm is a single-arm, mixed-methods feasibility study evaluating a virtual reality (VR) nature-based mindfulness intervention with children and adolescents aged 6-17 years, parents, and clinicians. Children complete one guided mindfulness session combining an immersive 360° nature environment with breathing, sensory awareness, and grounding exercises. Parents and clinicians view the intervention through a secure online link. The study examines feasibility, acceptability, engagement, usability, perceived usefulness, and child tolerability. It also explores immediate changes in children's anxiety, calmness, state mindfulness, and nature connectedness. Feedback from children, parents, and clinicians will guide further refinement of Operation Calm before it is evaluated in a larger clinical study.

VR for Steroid Joint Injections - Feasibility

The goal of the project is to implement virtual reality for pain and anxiety management for patients undergoing intra-articular glucocorticoid injections in the outpatient pediatric rheumatology clinic.

Virtual Reality-Assisted Cast Application in Children With Forearm Fractures

This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied. The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.

The Effects Of Virtual Reality and Stress Ball Application on Pain, Anxiety Levels and Injection Satisfaction in During Insulin Injection in Geriatric Patients With Type 2 Diabetes

The effects of virtual reality and stress ball applied during insulin injection on pain, anxiety levels and injection satisfaction in geriatric patients with type 2 diabetes. Insulin injection in geriatric patients with type 2 diabetes causes pain and anxiety, making the treatment process difficult. The aim of the study is to determine the effect of virtual reality and stress ball application on pain, anxiety levels and injection satisfaction during insulin injection in geriatric patients with Type 2 diabetes. Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria at Tarsus State Hospital to 3 groups (1st experimental group, 2nd experimental group and 3rd group control group) through a computer program. Considering that there may be case losses, a total of 90 patients (1st Experimental Group \[virtual reality applied\]: 30 patients, 2nd Experimental Group \[stress ball applied\]: 30 patients, control group: 30 patients) will be included in the sample group. In collecting data; A data collection form consisting of "Personal Information Form", "Visual Analog Scale (VAS)", State Anxiety Inventory (DCI), "Visual Patient Satisfaction Scale" forms will be used.

The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods. Research Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.

Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children

This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure. Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure. Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.

Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy

This randomized controlled trial aims to determine whether white noise affects salivary cortisol levels and vital signs in adult patients undergoing gastroscopy. Participants will be randomly assigned to either a white noise group or a control group receiving routine care. Patients in the intervention group will listen to white noise in accordance with the study protocol. Saliva samples will be collected to assess cortisol levels, and vital signs will be measured at predetermined time points. The results of the two groups will be compared to evaluate whether white noise helps reduce the physiological stress response associated with gastroscopy.

Three Distraction Techniques for Pain and Anxiety in Children During Allergy Skin Prick Testing

This randomized controlled trial compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. A total of 161 children were randomly assigned to four groups. Pain was rated by the child, a parent, and the researcher with the Wong-Baker FACES Pain Rating Scale during and after the procedure, and anxiety was rated by the parent and the researcher with the Children's Fear Scale before, during, and after the procedure.

VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures

This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic. Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care). The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups. Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial). Each participant's involvement consists of one visit, estimated at 30 minutes.

Technology-Based Distractions for Minor Procedures

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

Little NIRVANA for Pediatric Pain and Anxiety

The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.

Effect of Music on Pain and Anxiety During Nail Biopsies

This study is looking at whether listening to music during a nail biopsy can reduce pain and anxiety. Patients scheduled for a nail biopsy at the Weill Cornell Medicine dermatology clinic will be randomly assigned to either listen to a calming instrumental/classical music playlist during their procedure or receive standard care without music. After the procedure, participants will complete short questionnaires rating their pain, anxiety, and overall satisfaction. The goal is to determine whether a simple, low-cost music intervention can improve the experience of patients undergoing nail biopsies.

VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain

Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes. Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures. The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction. Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality.

Oral Surgery Virtual Reality Glasses Study

The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses. This study has two primary objectives. 1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure. 2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure. 80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).

Artificial Intelligence-Supported Visual Guide for Preschool Children Undergoing Medical Procedures

Children frequently experience anxiety, pain, and negative behavioral changes during common medical procedures such as venous blood sampling, vaccination, injection, and peripheral intravenous catheter insertion. Providing developmentally appropriate procedural preparation before these procedures may improve children's experiences and reduce procedure-related distress. This multicenter randomized controlled trial evaluates the effectiveness of an artificial intelligence (AI)-supported visual guide developed to prepare preschool children aged 3-6 years for common medical procedures. The intervention consists of standardized 1-3-minute procedure-specific educational videos created using Google Gemini 2.5 Pro (Google DeepMind) and finalized using CapCut. The videos incorporate researcher-developed educational scripts, AI-generated illustrations, and AI-generated voice narration to provide child-friendly, visually engaging, and developmentally appropriate procedural preparation. A total of 110 children are randomly assigned to either an intervention group receiving the AI-supported visual guide before the procedure or a control group receiving routine care. The primary outcome is procedural anxiety assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes include procedural pain measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) Pain Scale and post-procedural behavioral changes measured using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety

This research will be conducted in a pre-test-post-test parallel group randomized controlled experimental study model to determine the effects of rain stick and musical egg applied during blood collection on pain, fear and anxiety in children aged 4-6. Research Hypotheses H1: The mean pain scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H2: The mean fear scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H3: The mean anxiety scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H4: The mean pain scores of the children in the musical egg group are lower than the mean scores of the children in the control group. H5: The mean fear scores of the children in the musical egg group are lower than the mean scores of the children in the control group. H6: The mean anxiety scores of the children in the musical egg group are lower than the mean scores of the children in the control group.

Effect of Buzzy®, Cognitive Behavioral Intervention, and Kaleidoscope During SC Injection in Children With Cancer

Subcutaneous injections are commonly used in pediatric oncology care and may cause pain, fear, and anxiety in children. Repeated exposure to needle-related procedures may increase procedural distress and affect children's cooperation and coping during treatment. Therefore, simple, safe, and feasible non-pharmacological interventions are needed to improve children's comfort during routine procedures. This randomized parallel trial was designed to compare three clinically feasible non-pharmacological approaches with different mechanisms during subcutaneous injections in children with cancer. Buzzy® provides cold and vibration as a sensory-based method, the cognitive behavioral intervention package supports preparation and coping, and the kaleidoscope provides visual distraction. By comparing these approaches within the same procedural context, the study aimed to provide practical evidence for pediatric oncology nurses when selecting interventions to reduce procedural distress. All procedures were conducted in the routine clinical procedure area of a pediatric oncology clinic. The same subcutaneous injection procedure was used for all participants, and standardized assessment time points were applied before and immediately after the procedure.

Stress Ball and Empathic Verbal-Tactile Interventions for Reducing Anxiety and Pain in Mammography and Breast Ultrasonography: A Randomized Trial

This prospective, randomized controlled trial aims to determine the effects of stress ball use and empathic verbal communication with therapeutic touch on anxiety and pain perception in women undergoing mammography and breast ultrasonography. The study will be conducted between May and September 2026 at Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital. A total of 122 women meeting the inclusion criteria will be randomly assigned into three groups: stress ball group (n=41), empathic verbal communication with touch group (n=41), and control group (n=40). Women in the stress ball group will be instructed to use a soft stress ball before and during the procedure. Participants in the empathic verbal-tactile group will receive structured verbal empathy combined with therapeutic touch. The control group will receive routine care without additional intervention. Data will be collected before and after the procedures using a Descriptive Characteristics Form, the State-Trait Anxiety Inventory, and a Numerical Rating Scale for pain assessment. The findings of this study are expected to provide evidence on the effectiveness of non-pharmacological interventions in reducing anxiety and pain during breast imaging procedures.

Video-based Intervention to Reduce Anxiety in Patients Undergoing Elective PCI

This study aims to evaluate the effectiveness of a video-based educational intervention in reducing anxiety among hospitalised patients scheduled for elective percutaneous coronary intervention (PCI). Participants will be assigned to either a video intervention group or a control group without randomisation. The intervention group will receive a structured educational video related to the PCI procedure, while the control group will receive usual care. Anxiety levels will be measured using the State-Trait Anxiety Inventory at baseline and after the intervention to determine whether the video intervention reduces anxiety before the procedure.

Virtual Reality (VR) for Interventional Radiology (IR) Procedures

The goal of this clinical trial is to to utilize Virtual Reality during their interventional radiology procedure to help reduce any pain and anxiety experienced during the procedure in patients above the age of 8 undergoing interventional radiology procedures. The main questions it aims to answer are: * To determine if Virtual Reality is more effective than standard care for reducing pain and anxiety in children undergoing painful interventional radiology procedures. It is hypothesized that children in the Virtual Reality condition will experience reduced pain and anxiety compared to children receiving standard of care. * To evaluate caregiver's assessment of patient distress and their satisfaction with Virtual Reality compared to standard of care. It is hypothesized that caregiver satisfaction with the medical procedure will be significantly greater in the Virtual Reality group compared to the standard of care group. It is hypothesized that caregivers will perceive lower pain/anxiety when their child receives Virtual Reality compared to standard of care. Participants will complete pre and post surveys before and after interventional radiology procedures. Participants will use Virtual Reality headsets while undergoing procedure.

Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.

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.