Clinical Research Directory

AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia

This randomized clinical trial aims to compare two behavior guidance techniques used to reduce anxiety in children during local anesthesia injections in dental treatment. The study evaluates the traditional Tell-Show-Do (TSD) technique versus an artificial intelligence (AI)-driven, avatar-based video method called the "Mini Dentist." Children aged 5 to 7 years who require local anesthesia for routine dental treatment will be randomly assigned to one of two groups. The control group will receive the conventional Tell-Show-Do explanation from the pediatric dentist. The experimental group will watch a short animated video featuring an AI-generated avatar that explains and demonstrates the procedure in a child-friendly manner before the injection. Anxiety and behavior will be assessed using heart rate monitoring, behavioral observation (FLACC scale), and a self-reported pain scale (Wong-Baker FACES). The goal is to determine whether the AI-based method improves cooperation and reduces anxiety compared to the traditional approach. Participation is voluntary, and all procedures follow ethical research standards.

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.

Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety

The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction in children.

Lavender vs Bitter Orange Aromatherapy to Reduce Anxiety and Pain in Pediatric Local Anesthesia

This randomized controlled clinical trial aims to evaluate and compare the effectiveness of lavender essential oil and bitter orange essential oil aromatherapy in reducing dental anxiety and pain in children during the administration of local anesthesia. Children aged 6-12 years undergoing dental procedures requiring local anesthetic infiltration will be randomly assigned to lavender aromatherapy, bitter orange aromatherapy, or placebo (empty inhaler). Dental anxiety will be assessed using pulse rate and blood pressure measurements, while pain will be evaluated using the FLACC behavioral pain scale. The findings are expected to provide evidence on the role of aromatherapy as a non-pharmacological, safe, and cost-effective behavior guidance method in pediatric dentistry.

Effect of AI-Supported Child-Friendly Communication on Dental Anxiety in Pediatric Patients

This study compares the effects of traditional behavior management techniques and AI-assisted child-friendly communication on dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 6-12. The aim is to evaluate the effectiveness of AI-supported communication tools in reducing anxiety and improving comfort in pediatric dental treatments, potentially enhancing clinical outcomes and advancing technology use in pediatric dentistry.

Hysteroscopy Anesthesia for Relief of Pain

This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured. This study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS). The primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates. Patients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis. Inclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent. A total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled. The results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.

Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial

This multicenter randomized trial compares the clinical effectiveness of intraligamentary injection versus inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. The goal is to determine which technique provides better pain control during endodontic treatment.

RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

Percutaneous left atrial appendage closure (LAAC) is an effective strategy for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Standard procedure requires general anesthesia, transesophageal echocardiography (TEE) guidance. With the experience accumulation, LAAC can be successfully completed in many centers under local anesthesia, the guidance of X-ray and transthoracic echocardiography (TTE), also known as minimalist procedure. Our center was one of the earliest to carry out minimalist procedure worldwide. At present, expert consensus suggests that minimalist procedure is feasible in experienced centers, but the relevant evidence is insufficient. Some single-arm studies have shown that minimalist procedure is safe and effective. However, there is currently a lack of direct evidence to compare the strengths and weaknesses of these two LAAC procedures. The goal of the study was to compare the effectiveness and safety of minimalist procedure and standard procedure for LAAC in patients with NVAF.

The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration

Manual vacuum aspiration (MVA) is one of the surgical treatment options for managing early pregnancy loss. When compared to traditional surgical method; MVA is safer, more cost-effective, due to its shorter hospitalisation period and not undergo the risk of general anaesthesia. The MVA procedure is performed under local anaesthesia and analgesics is given prior the procedure. However, majority of patients still complaint significant pain during the procedure. In our previous study, the investigator found women had high anxiety and stress levels when undergo miscarriage and the operation. Pain perception may further be affected by one's psychological state at the time of the procedure. Therefore reducing the patient's anxiety during the USG-MVA may further improve the patient's pain control and overall acceptance of the procedure. Music can act as a distracter and has a calming effect which turn the patient's attention away from negative stimuli. Yet, there has been no RCTs to investigate the beneficial effect of music therapy in pain control or reducing anxiety levels during USG-MVA. The investigator hypothesis the intervention of music therapy to our current pain control will reduce the pain and anxiety levels experienced by our patients during USG-MVA. Thus, there is a need to conduct an RCT to test our hypothesis. The study is conducted in an university affilated hospital for women undergo the USG-MVA procedure. The primary outcome is to evaluate in between group difference in the pain intensity after the USG-guided MVA procedure. The secondary outcome is to evaluate the difference in anxiety level . Case is randomized to music and non music group, Bluetooth headphone are provided during the procedure and case can choose their favourite songs. The outcome are measured by the self rated instrument: Visual analogue scale and the STAI trait anxiety score and the physiological measure salivary alpha amylase (sAA )score. The pain score and the anxiety level is measured pre operatively, immediate after the procedure and 2 hours post operatively. The SPSS-26 will be used for statistics analysis.

Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.

The goal of this triple blind randomized clinical trial is to compare the safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism. The main questions it aims to answer are: * The anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area. * The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area. * The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area. The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter. The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block. The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch. Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such. * Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the surgery will not know to which group each patient belongs. * The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.

Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures

to assess the success of wide-awake local anaesthesia In fixation of ankle fractures

Can Caudal Dexmedetomidine Provide Effective Analgesia?

The goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine). The main question it aims to answer is: * Can caudal dexmedetomidine provide effective analgesia? Participants will be pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries. \- A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups: * Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg. * Group D (n =25): In this group, and after injection of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.