Clinical Research Directory

Effects of Music on Preoperative Anxiety and Emergence Delirium in Children

This randomized controlled trial aims to evaluate the effects of classical music listening on preoperative anxiety and postoperative emergence delirium in children aged 9-12 years undergoing elective surgery. Participants were randomly assigned in a 1:1 ratio to either a music intervention group or a control group receiving routine care. Children in the intervention group listened to classical music during the preoperative period and during emergence from anesthesia. Preoperative anxiety and the incidence and severity of emergence delirium were compared between the two groups.

Daily Screen Exposure and Preoperative Anxiety in Children Aged 2-5 Years

This prospective observational study aims to evaluate whether daily screen exposure duration is associated with preoperative anxiety levels in children aged 2-5 years undergoing elective surgery. Screen exposure in early childhood has been associated with emotional and behavioral outcomes, including increased anxiety. However, its potential impact on anxiety in acute stress situations such as surgery has not been previously investigated. Preoperative anxiety in children is associated with difficult anesthetic induction, increased postoperative agitation, prolonged recovery, and behavioral disturbances. In this study, parents will complete a structured questionnaire assessing their child's daily screen exposure duration and related factors. Children will be categorized into three groups according to reported daily screen time: less than 1 hour per day, 1-2 hours per day, and more than 2 hours per day. Preoperative anxiety will be assessed immediately before anesthesia induction using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational tool for measuring anxiety in young children. No additional medical interventions will be performed beyond routine clinical care. The study seeks to determine whether higher screen exposure is associated with increased preoperative anxiety levels and to identify potential risk factors contributing to anxiety in preschool children undergoing surgery.

Passiflora Incarnata for Dental Extraction Anxiety

This study looks at whether Passiflora incarnata (passionflower extract) can help reduce anxiety before tooth extraction. Male participants who feel high anxiety before the procedure will receive either passionflower extract or an inactive substance (placebo) before their extraction. Neither the participants nor the researchers will know who receives which one. The study will compare anxiety levels using a questionnaire, along with body responses such as heart rate and blood pressure. The goal is to find out whether this natural option could help patients who fear tooth extraction, without the use of medication

Impact of Video-Based Patient Education on Physician Trust, Pain, and Anxiety in Laparoscopic Cholecystectomy

This prospective, randomized, single-center, single-blind study aims to evaluate the effects of video-based preoperative education on physician trust, postoperative pain, anxiety, and opioid consumption in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Sixty-two ASA I-II patients aged 18-65 years will be randomized into two groups: standard verbal information alone or verbal information plus a standardized educational video regarding ultrasound-guided transversus abdominis plane (TAP) block. All patients will receive standardized general anesthesia, multimodal analgesia, and bilateral TAP block. The primary outcome will be physician trust assessed at postoperative 24 hours using the Trust in Physician Scale. Secondary outcomes include preoperative anxiety measured with the Amsterdam Preoperative Anxiety and Information Scale (APAIS), postoperative pain scores, opioid consumption, rescue analgesic requirement, and postoperative nausea and vomiting incidence. The study hypothesizes that video-based education will improve physician trust and perioperative patient-centered outcomes.

Virtual Reality Storytelling Versus Storybook Reading for Dental Anxiety in Children

Many children feel anxious before dental treatment. This study compares two ways of helping children feel calmer while waiting for their dental visit: watching a dental story through virtual reality (VR) glasses, or listening to the same story read aloud by the dentist from a printed storybook. The story is in Arabic and follows a girl named Amira during her first dental visit. The story is identical in both groups, so the only difference is how it is delivered. Healthy children aged 6 to 10 years will be randomly assigned to one of the two groups. The main outcome is the child's heart rate, measured before and after the story as an objective sign of anxiety. Children's dental fear will also be assessed with two child-friendly scales, and parents' own dental anxiety will be measured to see whether it is related to their child's anxiety. The study aims to find out whether VR storytelling differs from a traditional storybook in its effect on children's anxiety before dental treatment.

Humor-Based Video Intervention on Preoperative Anxiety Veya Humor Video and Recovery in Cholecystectomy

This study aims to evaluate whether watching a short humor-based video before surgery can reduce anxiety and negative emotions and increase positive emotions in patients undergoing elective laparoscopic cholecystectomy (gallbladder removal surgery). The study will also examine whether this intervention affects patients' quality of recovery after surgery. Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to either a humor-based video intervention group or a control group. In addition to routine preoperative care and education, patients in the intervention group will watch an approximately 20-minute humor-based video before surgery. Patients in the control group will receive routine preoperative care and education without the humor-based video. Anxiety, positive and negative emotions, and postoperative quality of recovery will be assessed using standardized questionnaires. The study will compare these outcomes between the two groups to determine whether the humor-based video provides beneficial effects during the perioperative period.

Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care

This study investigates whether an Enhanced Recovery After Surgery (ERAS) program can help orthopedic surgery patients feel less anxious before their operation and recover better one year after surgery, compared to conventional (standard) surgical care. Patients who undergo orthopedic surgery, such as joint replacement, often experience significant anxiety before the operation. While ERAS programs, which combine patient education, pain management, and early mobilization, have been shown to shorten hospital stays and reduce complications, less is known about whether they also reduce preoperative anxiety and lead to better long-term outcomes reported by patients themselves. In this prospective cohort study, patients receiving ERAS care will be compared with patients receiving conventional care. Preoperative anxiety will be measured using a validated questionnaire (APAIS). Clinical recovery during hospitalization, including length of stay, pain scores, and opioid use, will also be recorded. Patients will then be followed for one year to assess their quality of life (EQ-5D-5L) and their own impression of overall improvement (Patient Global Impression of Change). The goal of this study is to determine whether ERAS not only improves short-term surgical recovery, but also reduces preoperative anxiety and leads to better long-term, patient-centered outcomes.

Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery

This randomized controlled trial aims to investigate the effects of preoperative video-assisted patient education combined with eye position fixation training on anxiety, pain, intraoperative compliance, operation duration, and physiological parameters in adult patients undergoing primary pterygium surgery under local anesthesia. A total of 152 patients aged 18 to 75 years scheduled for primary pterygium excision with conjunctival autograft will be randomly assigned to either the intervention group (n = 76) or the control group (n = 76). Patients in the intervention group will receive an 8-to-10-minute tablet-based audiovisual surgical preparation module prior to surgery. This module consists of two stages: (1) cognitive preparation based on Enhanced Recovery After Surgery (ERAS) principles, including 2D animations of the procedure, desensitization to operating room sights and sounds, and postoperative care instructions; and (2) interactive eye position fixation and motor compliance training. Patients in the control group will receive standard routine verbal preoperative information. Anxiety levels, pain intensity, and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed preoperatively and postoperatively. Intraoperative patient compliance and surgical comfort will be evaluated immediately after surgery by a blinded surgeon, along with total operation duration and intraoperative physiological parameters.

Music Intervention to Reduce Anxiety and Prevent Delirium in Older Adults Undergoing Cardiac Surgery

The goal of this clinical trial is to evaluate the effectiveness of the music intervention in preventing postoperative delirium (POD) in older patients undergoing elective cardiac surgery. The primary question is: Among older adults undergoing elective cardiac surgery, does offering a structured perioperative music intervention in addition to standard care reduce the incidence of POD within the first five postoperative days compared with standard care alone? The secondary questions are: Does perioperative music intervention reduce preoperative anxiety (PA) among older patients undergoing cardiac surgery, and does the level of PA moderate the effect of the music intervention on POD? Researchers will compare music intervention to routine care to see if music intervention can reduce PA and prevent POD. Participants will listen to music before and after surgery, be assessed for PA and POD, and participate in an interview about participants' perspectives on the music intervention.

Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures worldwide. Although the widespread implementation of Enhanced Recovery after Surgery (ERAS) protocols has improved perioperative outcomes, many patients continue to experience postoperative pain, sleep disturbance, anxiety, nausea, and fatigue, symptoms that collectively impair overall quality of recovery (QoR). Melatonin, an endogenous hormone that regulates circadian rhythm, also possesses anxiolytic, analgesic, antioxidant, and anti-inflammatory properties, positioning it as a valuable perioperative adjunct. However, most previous studies have evaluated melatonin primarily for isolated outcomes such as sleep quality or anxiety. Its effect on comprehensive postoperative recovery, assessed using validated patient-reported outcome instruments, remains insufficiently explored, particularly in laparoscopic cholecystectomy populations and in South Asian clinical settings. This prospective, randomized, double-blind, placebo-controlled trial (the MEL-REC trial) aims to evaluate the effect of preoperative oral melatonin on postoperative quality of recovery in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. The study will be conducted in the Department of Anaesthesiology at Combined Military Hospital (CMH), Dhaka, Bangladesh, over a total study period of 18 months (January 2026 to June 2027), with patient recruitment planned for 8 months (May to December 2026) after taking approval from institutional review board. Eighty four adult patients aged 18-60 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly allocated in a 1:1 ratio into two equal groups (n = 42 per group) using computer-generated permuted block randomization with centralized pharmacy based allocation concealment. The melatonin group (Group M) will receive oral melatonin 6 mg administered 60 minutes before induction of anaesthesia and the placebo group (Group P) will receive an identical placebo tablet under the same conditions. Neither the participants, the treating anaesthesiologist, the outcome assessor, nor the data analyst will be aware of group allocation until database lock. All patients will receive a standardized anaesthesia and perioperative management protocol, including standardized postoperative analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) score at 24 ± 2 hours after surgery. Secondary outcomes include postoperative sleep quality measured by the Richards-Campbell Sleep Questionnaire, change in preoperative anxiety (delta-VAS-A score), total opioid consumption during the first 24 hours expressed as intravenous morphine milligram equivalents, incidence of postoperative nausea and vomiting, and time to first rescue analgesic request. All postoperative outcomes will be assessed by a trained research assistant blinded to group allocation. Based on the available evidence, it is anticipated that patients receiving preoperative melatonin will demonstrate higher QoR-15 scores at 24 hours after surgery compared with the placebo group. The melatonin group is also expected to have improved postoperative sleep quality, reduced opioid consumption, and a greater reduction in preoperative anxiety. If a clinically meaningful benefit is confirmed, given its well established safety profile, low cost, and ease of oral administration, preoperative melatonin may represent a practical perioperative adjunct that can be readily incorporated into ERAS protocols for laparoscopic cholecystectomy. The trial will be prospectively registered in the Bangladesh Medical Research Council (BMRC) clinical trial registry or clinicaltrials.gov prior to recruitment.

Virtual Reality for Pediatric Perioperative Preparation

This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff. The VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery. The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.

Positive Affirmations and Preoperative Anxiety

This study is a prospective, quasi-experimental design using a convenience sample. This study will include patients who are having total knee or total hip replacement surgery. Participants will be invited to complete an anxiety scale at the conclusion of the total joint replacement (TJR) education class, listen to a guided imagery and positive affirmations recording once/day for three days prior to surgery, beginning on the third day before surgery and continuing to the day before their scheduled surgical procedure, listen to positive affirmations the morning of surgery in the preop area, and then complete an anxiety scale before entering the operating room.

Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.

Digital Storytelling-Based Animation for Preoperative Anxiety in Children

This randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Participants are randomly assigned to either an intervention group, which watches a digital storytelling-based animation before the procedure, or a control group receiving standard preoperative care. Anxiety is assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and Facial Image Scale (FIS). Physiological parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, are also evaluated. The study aims to determine whether the animation-based intervention reduces preoperative anxiety and physiological stress responses in children.

Video Versus Verbal Preoperative Education in Elective Cesarean Delivery

This prospective randomized controlled trial aims to evaluate the effects of verbal and video-based preoperative education on anxiety levels and serum cortisol response in women scheduled for elective cesarean delivery under spinal anesthesia. Eligible participants will be randomly assigned to receive either standard verbal education or a standardized video-based educational intervention before surgery. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-S), and serum cortisol levels will be measured before and after the educational intervention. The primary objective is to compare the effectiveness of the two educational methods in reducing preoperative anxiety and physiological stress response.

Effect of Clinical Hypnosis in Preoperative Anxiety Among Patients Undergoing an Abdominal Surgery.

This Multicenter randomized controlled trial evaluates clinical hypnosis efficacy for reducing perioperative anxiety and postoperative pain in abdominal surgery patients across 3 Moroccan centers (n=48-68). Intervention arm receives 15-20 min level 2 hypnosis session preoperatively; control receives standard psychological preparation. Primary outcome: VAS-anxiety post-intervention. Secondary: postoperative EVA-pain, analgesic consumption, length of stay. Study Design Prospective, multicenter, parallel-group RCT (1:1 allocation, stratified by center/sex). Inclusion: consenting ASA I-II adults for abdominal surgery. Primary endpoint powered for 10mm EVA reduction (80% power, α=0.05). Registration supports PhD thesis at ISSS/Université Hassan 1er Settat.

The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients

Study Design and Participants This study employed a prospective, randomized controlled trial (RCT) design. A total of two study arms were established: an experimental group receiving a virtual reality (VR) education intervention combined with conventional care, and a control group receiving a unit health education film with conventional care. Participants were recruited based on the following inclusion criteria: adults aged 18 years or older scheduled for elective hip or knee replacement surgery under spinal anesthesia; an American Society of Anesthesiologists (ASA) physical status grade of I to III; clear consciousness with the ability to read and understand Chinese; and no prior diagnosis of anxiety disorders or significant visual/hearing impairments. Patients were excluded if they had a history of head trauma or chronic dizziness, or if they required post-operative transfer to the intensive care unit (ICU) due to medical complications. Randomization and Intervention Eligible participants were assigned to either the experimental or control group using block randomization to ensure balanced group sizes. The primary intervention for the experimental group consisted of a structured Virtual Reality Education Program, while the control group received standard institutional health education via video. Data Collection and Instrumentation A repeated-measures approach was utilized for data collection across four distinct time points: (1) baseline (one day prior to surgery), (2) pre-operative arrival at the operating room holding area on the day of surgery, (3) one day post-operatively, and (4) three days post-operatively. The research instruments used for assessment included: A demographic profile sheet. The State-Trait Anxiety Inventory (STAI). The Visual Analogue Scale for Anxiety (VAS-A). The Visual Analogue Scale for Pain (VAS-P). A Virtual Reality Education Satisfaction Questionnaire. Standardized physiological indicators.

Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Cortisol Levels in Elective Cesarean Section

Preoperative anxiety is a common problem in patients undergoing elective cesarean section and may negatively affect perioperative outcomes through activation of the stress response, including increased cortisol levels. Effective preoperative information is considered a key non-pharmacological strategy to reduce anxiety; however, the optimal method of information delivery remains unclear. This prospective randomized controlled trial aims to compare the effects of video-based versus verbal preoperative information on anxiety levels and serum cortisol response in patients scheduled for elective cesarean delivery under spinal anesthesia. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), and serum cortisol levels will be measured before and after the intervention. The findings of this study are expected to provide evidence for improving patient-centered preoperative education strategies in obstetric anesthesia."

Preoperative Anxiety in Patients Undergoing RIRS and PCNL

This prospective observational cohort study aimed to compare preoperative anxiety levels in adult patients undergoing retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) for renal stones. The surgical approach was determined according to routine clinical indications and was not assigned by the study protocol. Preoperative anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Demographic, clinical, and stone-related characteristics were also recorded to evaluate factors associated with preoperative anxiety.

Aromatherapy and Its Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience

Aromatherapy's Impact on Preoperative Anxiety, Postoperative Pain, and Patient Experience Introduction: Surgery often results in increased levels of anxiety and postoperative pain. Postoperative pain relief is typically treated with opioids. However, evidence shows that treatment with opioids alone is often insufficient to provide adequate levels of pain relief and can contribute to the growing opioid crisis. Alternative pain management strategies that combine narcotic medication with complementary therapies can improve comfort as well as decrease preoperative anxiety. Aromatherapy is an evidence-based complementary therapy used to decrease preoperative anxiety and postoperative pain that has been underutilized in ambulatory surgical centers. This study aimed to evaluate the impact Aromatherapy has as an anxiety and pain management strategy. Subsequently, evidence also supports that improving the patient experience can lead to better surgical outcomes. Study Aim: This study will examine the effect that aromatherapy has on preoperative anxiety, postoperative pain and patient experience Study Question(s): In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect preoperative anxiety? In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect postoperative pain? In perioperative patients at Kaiser Stockton Ambulatory Surgery Unit, how does aromatherapy, compared with standard practice, affect patient experience? Study Method: Prospective Experimental Randomized Control Clinical Trial Study Duration: 18 months Study Process: The participants will be recruited through their Pre-surgery interview, at which time a brief explanation will be given on aromatherapy, its potential to reduce preoperative anxiety and postoperative pain, and increase the patient experience. The study design and protocol will also be described. Should the participants elect to participate in this study, they will be randomly assigned using a computer program. Upon arrival for surgery, informed consent will be obtained. Anxiety and pain will be assessed for pre- and post- intervention and just before transferring to the operating room (OR). Upon arrival to the Post-Anesthesia Care Unit (PACU), pain will be assessed in 15-minute intervals until discharge. Anxiety will be reassessed at discharge. Experience will be assessed 2 weeks after discharge. Data Analysis: A one-way Multivariate Analysis of Variance (MANOVA) will be used to assess the impact of aromatherapy on pain, anxiety, and satisfaction. Conclusions: This study aims to add to the body of knowledge of how the incorporation of aromatherapy can impact patient outcomes.

Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children

Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.

Reducing Fear and Anxiety in Children Through Free Play

The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups. The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels. Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables. In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play. Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents. Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups. An a priori power analysis was performed using G\*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group. The hypotheses of the study were: H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores. H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group. H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores. H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group. H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores. H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group. H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.

Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients

Background and rationale: Colonoscopy is central to colorectal cancer screening and prevention, but its diagnostic yield depends heavily on adequate bowel preparation; inadequate cleansing lowers adenoma detection and often necessitates repeat procedures. Pre-procedural anxiety is also common, particularly among patients undergoing colonoscopy for the first time. Conventional education is constrained by time and does not always address individual questions. Large language model-based tools such as ChatGPT can generate individualized, real-time responses and may serve as an adjunct to standard counseling. Objective: To evaluate whether ChatGPT-assisted pre-procedural patient education, added to standard information, improves bowel preparation quality and reduces pre-procedural anxiety compared with standard information alone in patients undergoing their first colonoscopy. Design and setting: Single-center, parallel-group, two-arm randomized controlled trial conducted in the Department of Gastroenterology, Gazi University Faculty of Medicine, Ankara, Türkiye. The study was approved by the Gazi University Clinical Research Ethics Committee (approval no. 2025-1016). Written informed consent was obtained from all participants. Participants: Adults (aged ≥18 years) presenting for their first colonoscopy were eligible. \[Buraya kalan dışlama kriterlerini ekle - ör. önceki kolonoskopi öyküsü, tablet kullanamama, ciddi bilişsel/işitsel engel vb.\] Randomization and allocation: Eligible participants were randomly assigned in a 1:1 ratio to the standard-information (control) arm or the ChatGPT-assisted (intervention) arm, with allocation concealment. Interventions: Control arm: standard pre-procedural verbal and written bowel-preparation instructions per routine clinical practice. Intervention arm: the same standard instructions plus supervised access to a ChatGPT interface (GPT-4o model, ChatGPT Plus) on a clinic-provided tablet before the procedure. Participants could ask questions in their preferred language, up to a maximum of ten. Chatbot responses were reviewed by the study team for clinical appropriateness. Outcome measures: Primary: (1) bowel preparation quality assessed with the Boston Bowel Preparation Scale (BBPS); (2) pre-procedural anxiety assessed with the State-Trait Anxiety Inventory (STAI). Secondary: procedural tolerance (5-point Likert scale); adenoma detection rate; and completion of colonoscopy without sedation. Sample size: Based on an a priori power analysis assuming a moderate effect size (Cohen's d ≈ 0.50) for the primary outcomes, with two-sided alpha of 0.05 and 80% power. Statistical analysis: Outcomes were analyzed following the intention-to-treat principle. Between-group comparisons used t-test or Mann-Whitney U for continuous variables and chi-square/Fisher exact tests for categorical variables; multivariable logistic regression was used for binary outcomes.

QR Code-Based Video-Supported Anesthesia Information and Preoperative Anxiety

This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery. Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard written informed consent and routine verbal anesthesia information or an intervention group receiving the same standard information plus a standardized video-based educational intervention accessed through a QR code. The primary outcome is the change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score before and after the information process. Secondary outcomes include comprehensibility of information and patient satisfaction assessed using a structured Likert-type questionnaire. The findings may contribute to the standardization of patient information processes in anesthesia outpatient clinics through a low-cost and easily implementable digital educational approach.