Clinical Research Directory

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).

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.

Cartoon Watching Versus Ball Squeezing During Venous Blood Sampling in Children

This single-center, parallel-group, randomized experimental study will compare the effects of two non-pharmacological distraction/coping interventions - cartoon watching and ball squeezing - on procedural pain and pain-related fear during venous blood sampling in children aged 6-9 years. The study will be conducted in the Pediatric Blood Collection Unit of Mersin University Hospital. Eligible children will be randomized to either the cartoon-watching group or the ball-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after venous blood sampling. Hypotheses * H1a: There is a difference between groups in mean WB-FACES scores during the procedure. * H1b: There is a difference between groups in mean CFS scores during the procedure.

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).

ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)

This study evaluated the effects of ShotBlocker and a warm gel pack on pain, comfort, and physiological parameters during heel prick testing in healthy term newborns. A three-arm randomized controlled trial was conducted at a city hospital between October 2025 and May 2026. Newborns were randomly assigned to the ShotBlocker group, warm gel pack group, or routine care group. Pain was assessed using the Neonatal Infant Pain Scale (NIPS), and comfort was assessed using the Neonatal Comfort Behavior Scale (NCBS). Heart rate, respiratory rate, oxygen saturation, and heel temperature were also measured before and after the procedure. The study aimed to compare the effectiveness of these non-pharmacological interventions during routine heel prick testing.

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.

Cervical Preparation for Same-Day Dilation & Evacuation

This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.

Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children

This single-center, parallel-group, randomized experimental study will compare the effects of two active non-pharmacological interventions - distraction-card use and emotion-regulation toy squeezing - on procedural pain and pain-related fear during intramuscular tetanus vaccination in children aged 4-7 years. Eligible children will be randomized to either the distraction-card group or the emotion-regulation toy-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after the intramuscular injection procedure. Hypotheses * H1a: There is a difference between the groups in mean Wong-Baker FACES scores during the procedure. * H1b: There is a difference between the groups in mean Children's Fear Scale scores during the procedure.

Music-Assisted Acupressure for Pain During AVF Cannulation in Hemodialysis Patients

This randomized controlled trial was conducted to evaluate the effect of music-assisted acupressure on pain experienced during arteriovenous fistula (AVF) cannulation in hemodialysis patients. The study was carried out with 72 patients receiving hemodialysis treatment three times per week via AVF in a state hospital in Gaziantep, Türkiye. Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure alone, music alone, and control group (routine care). The acupressure intervention was applied to the Hegu (LI4) point for approximately 3 minutes prior to needle insertion, while the music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before cannulation and continuing until the end of the procedure. Pain intensity during AVF cannulation was measured using the Visual Analog Scale (VAS) during three consecutive dialysis sessions. The primary outcome was pain severity during needle insertion. The study aimed to determine whether combining music therapy and acupressure would provide greater pain relief compared to single interventions or routine care. Findings suggest that music-assisted acupressure may be an effective non-pharmacological nursing intervention for reducing procedural pain in hemodialysis patients.

THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE

What is this study about, in short? This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested: * A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go ("rhythmic skin tapping"). * The child making an "mmmm" humming sound while the blood is being drawn ("internal vibration" or "humming"). These methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method. Why is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children. Some methods used to reduce pain have practical limits: * Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost. * Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene. For these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that. How do the methods work? (Simple science) Both methods rest on an idea called the "Gate Control Theory": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a "gate" that partly blocks the pain signal from reaching the brain. * Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help "close the gate," so the pain is felt less. * Internal vibration (humming): The "mmmm" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control. Who can take part in the study? Can take part: * Children aged 6-12 years * Children who will have a blood draw * Children whose parent has given written permission and who themselves agree verbally * Children who can understand and speak Turkish * Children whose cognitive development is appropriate for their age * Children who do not have an ongoing (chronic) pain condition Cannot take part, or will be withdrawn: * Children who do not want to take part, or wish to withdraw at any stage * Children who develop a complication (an unexpected medical problem) during the procedure * Children who have used a painkiller within the last 24 hours * Children who have already taken part in this study before * Children whose skin is broken at the site where the needle will go * Children who have a neurological or psychiatric diagnosis What will happen if my child takes part? The blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step: * Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called "randomization" and it keeps the comparison fair. * The blood draw is done as usual. The only difference is the method used, depending on your child's group. * Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4). * A short form collects details such as age, sex, and any previous blood-draw experience. * No extra needle, medicine, or laboratory test is done beyond the routine blood draw. The three groups are: Group What is done in this group? 1. Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site. 2. Internal vibration (humming) The child is asked to make an "mmmm" humming sound during the blood draw. 3. Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods. Where and when will the study take place? * Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye). * Data collection period: June 2026 - June 2027. The total study duration is about 12 months. * Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable. Taking part is completely voluntary * Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason. * Not taking part, or withdrawing, will not affect the health care your child receives in any way. * Your child may also say they do not want the method; the child's decision is

TEAS for Sedation During ERCP: A Multicenter Trial With Mechanistic Substudy

1. The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy that applies mild electrical current to specific points on the skin, can help patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) better tolerate the procedure and experience fewer complications related to sedation. It will also explore the underlying neuro-endocrine-immune mechanisms by measuring changes in serum biomarkers. 2. The main questions the study aims to answer are: (1)Does TEAS reduce the incidence of sedation-related adverse events (such as low blood oxygen, low blood pressure, or breathing problems) during ERCP? (2)Does TEAS improve patient comfort and reduce the need for additional sedative medications during the procedure? (3)Does TEAS lead to faster recovery and higher patient and physician satisfaction? (4) Does TEAS modulate the neuro-endocrine-immune network, as reflected by changes in serum β-endorphin, cortisol, TNF-α, and IL-6 levels? 3.Researchers will compare two approaches: 1. Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP. 2. Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active). 4.All participants will receive standard conscious sedation with meperidine and diazepam, which is commonly used for ERCP in many centers. Participants will be randomly assigned to one of the two groups. The study will measure sedation-related complications, pain levels, medication requirements, recovery times, satisfaction scores, and changes in serum biomarkers (β-endorphin, cortisol, TNF-α, IL-6).

Social Robot Interaction on Fear and Pain Levels in Children

The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases. The main questions it aims to answer are: * Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling? * Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling. Participants will: * Be randomly assigned to one of three groups: social robot, digital game, or standard care. * Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure. * Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups. * Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children

The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.

Comparison of Compounded Topical Anesthetics

The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.

Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children

The goal of this clinical trial is to learn whether a needle-free injection system can make tooth extraction less stressful for children than a conventional dental syringe. The study will include healthy children 6 to 12 years old who need a primary tooth extraction with buccal and lingual local anesthesia. The main questions are whether the needle-free method can lower anxiety, lower pain, and reduce changes in vital signs compared with the conventional syringe. Researchers will randomly assign participants to 1 of 2 groups. One group will receive local anesthesia with a needle-free jet injection system. The other group will receive local anesthesia with a conventional syringe and a 27-gauge dental needle. In both groups, a topical lidocaine spray will be used before the injection, and the same anesthetic solution will be given. All tooth extractions will be performed by the same clinician using standard clinical procedures. Participants' anxiety, pain, and vital signs will be checked before the procedure, after anesthesia, and after tooth extraction. Anxiety will be measured with the Face Image Scale (FIS). Pain will be measured with the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale (WBS). Vital signs will include systolic and diastolic blood pressure, heart rate, and oxygen saturation. No blood, saliva, or tissue samples will be collected, and no audio or video recording will be made.

Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy

To investigate the application of Bagua ear therapy as an adjunctive intervention for perioperative pain management in patients undergoing hysteroscopic surgery, to analyze its effects on intraoperative and postoperative pain, and to compare the differences in pain outcomes between patients undergoing hysteroscopy under local anesthesia and those without anesthesia.

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.

Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain

Propofol is a commonly used intravenous anesthetic agent, but its administration is frequently associated with injection pain, causing patient discomfort and agitation. Various pharmacological agents have been used to reduce this pain, including nalbuphine and lidocaine; however, results from previous studies remain conflicting. This randomized clinical trial aims to compare the effectiveness of intravenous nalbuphine versus intravenous lidocaine in reducing the frequency of propofol-induced injection pain in patients undergoing elective general surgery procedures.

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.

Palm Stimulator Use During Peripheral Venous Catheterization

Purpose: The purpose of this study is to evaluate the effectiveness of a "Palm Stimulator" (a handheld device with blunt protrusions) in reducing pain, fear, and anxiety during peripheral venous catheterization (IV insertion) in adult cancer patients receiving chemotherapy. Methods: This is a randomized controlled clinical trial. Participants will be randomly assigned to either the Experimental Group or the Control Group. Experimental Group: During the IV insertion process, patients will hold and squeeze the Palm Stimulator in the palm of their non-procedural hand. The device is designed to provide intense tactile (touch) stimulation based on the "Gate Control Theory." Control Group: Patients will receive the standard routine care for IV insertion without any additional intervention. Data Collection: Pain intensity will be measured using the Visual Analog Scale (VAS), while fear and anxiety levels will be assessed through VAS scales before and after the procedure. Patient satisfaction with the device will also be recorded. Expected Outcome: The investigators hypothesize that the use of the Palm Stimulator will significantly decrease procedural pain and fear while increasing patient satisfaction compared to standard care. This study aims to provide a low-cost, non-pharmacological, and easy-to-use tool for oncology nurses to improve patient comfort during invasive procedures.

Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are: * Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients? * Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment? * Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment? Researchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment. Participants will: * Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1) * Either receive the TIPPI-R intervention or standard of care * Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)

The Effect of Two Different Interventions on Emotional State, Pain, and Fear During Respiratory Panel Removal in Children: A Randomized Controlled Study

Respiratory panel collection is a commonly used diagnostic procedure in children with suspected respiratory tract infections; however, it is often perceived as painful and distressing. Inadequately managed pain and fear during such procedures may negatively affect children's emotional responses to future medical interventions. This randomized controlled trial aims to evaluate and compare the effects of two non-pharmacological interventions-a palm stimulator and a stress ball-on pain, fear, and emotional behavior in children aged 6-12 years undergoing respiratory panel specimen collection. Participants will be randomly assigned to one of three groups: palm stimulator intervention, stress ball intervention, or routine care (control group). Pain, fear, and emotional responses will be assessed using validated pediatric measurement tools before, during, and after the procedure. The findings of this study are expected to contribute evidence on simple, practical, and developmentally appropriate non-pharmacological strategies that can be safely integrated into pediatric nursing practice to improve children's procedural experiences.

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.

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).