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NCT04209517
The purpose of this study is to identify the characteristics of patients' behavioural patterns related to declared anxiety levels in a day-care surgical unit using ethological analysis of video-recordings of the pre-operative interview with the nurse.
NCT07393945
This study investigates whether a structured, human-centered explanation about the use of artificial intelligence (AI)-supported real-time imaging systems can reduce preoperative anxiety and improve patients' sense of control before elective surgery. Advances in medical imaging and AI technologies have increased their visibility in clinical settings, including the perioperative period. However, limited information is available on how explanations about such technologies influence patients' psychological responses. In particular, uncertainty or misunderstanding about AI-supported systems may contribute to increased anxiety in some patients. In this randomized controlled trial, adult patients scheduled for elective surgery will be assigned to one of two groups. The control group will receive standard preoperative information routinely provided by the hospital. The intervention group will receive standard information plus a short, structured, and non-technical explanation about AI-supported real-time imaging systems, focusing on their role, limitations, and relevance to patient safety. Levels of preoperative anxiety and perceived control will be assessed before and after the information session using validated questionnaires. The study does not test or evaluate the technical performance of any AI system. Instead, it focuses on how communication and explanation about AI-supported technologies may influence patients' psychological preparedness for surgery. The findings may help inform human-centered and ethically responsible approaches to communicating about advanced technologies in perioperative care.
NCT07451925
Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. This variability may be influenced not only by the extent of surgical trauma but also by individual pain sensitivity and psychological factors such as preoperative anxiety. The aim of this prospective observational study is to evaluate whether pain intensity reported during routine venous cannulation and preoperative anxiety levels assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) can predict early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Venous cannulation pain will be assessed using a 0-10 visual analog scale (VAS), and anxiety levels will be measured preoperatively using APAIS. Postoperative pain will be evaluated at predefined time points within the first 12 hours after surgery using VAS scores and analgesic consumption. Identifying simple and easily obtainable preoperative predictors may allow individualized postoperative analgesic strategies for patients at higher risk of severe postoperative pain.
NCT07408037
This study aims to evaluate the effect of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in children. The intervention includes games like ball blowing and bubble blowing. Anxiety is measured using the mYPAS-SF scale, and delirium is assessed with the PAED scale.
NCT06489327
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety. In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance. Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.
NCT07297095
The effect of patient education given to patients undergoing colon surgery using virtual reality in the preoperative period on preoperative anxiety, postoperative pain and sleep is the subject of this study.
NCT06853431
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.
NCT07259551
Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy. Primary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II Methods: Patients were divided into two groups using a sealed envelope method: Group P: Patients who received the palm-based technique Group N: Control group without intervention When admitted to the preoperative waiting room (T1), all patients: Baseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention. The same parameters were measured again 15 minutes later (T2). After transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times: Pre-intubation (T3) 1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique Sample Size:Total: 80 patients
NCT06667596
This prospective, cross-sectional study aims to investigate the impact of planned anesthesia technique (general or regional anesthesia) and patients' previous anesthesia experience on preoperative anxiety in patients undergoing upper extremity surgery. The secondary objective is to identify the reasons for patients' anxiety related to anesthesia and surgery. Preoperative anxiety can lead to emotional, psychiatric, and physical problems, and is associated with increased autonomic fluctuations, anesthetic demand, postoperative nausea and vomiting, pain, prolonged recovery time, and hospitalization. The study will enroll 400 volunteers undergoing upper extremity surgery at Başakşehir Çam and Sakura City Hospital. Demographic information, surgical details, previous surgical and psychiatric history, substance abuse, and information about anesthesia will be collected. The Amsterdam Preoperative Anxiety and Information Form (APAIS) will be used to assess anxiety and desire for information, while the State-Trait Anxiety Inventory (STAI) will evaluate state and trait anxiety. Patients with an APAIS-A score ≥13 will be considered anxious, and those with an APAIS-B score ≥4 will be considered information-seeking. STAI scores will be interpreted based on percentile ranks and average score levels. The study aims to identify approaches to reduce preoperative anesthesia and surgery-related anxiety. SPSS Survey Analysis methods will be used for statistical analysis. The study duration is 12 months, from November 2024 to November 2025. Inclusion criteria are consenting patients aged 18-65 years, ASA I-III, undergoing upper extremity surgery under general or regional anesthesia, who are oriented and cooperative. Exclusion criteria include lack of consent, inappropriate age, ASA IV-V, non-upper extremity surgery, and inability to orient and cooperate.
NCT06648122
This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium
NCT05094141
The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access. The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome). The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR. The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.
NCT06979791
The goal of this 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.
NCT06709443
Anxiety is when children feel scared, worried, or nervous before or during anesthesia induction. This can happen because they don't know what's happening, are scared of the hospital or medical equipment, or are worried about being separated from their parents. When parents are present, they can: * Provide emotional support and reassurance * Distract the child from scary things * Help the child feel more calm and safe This can help reduce the child's anxiety levels. When parents are not present, children may feel: * More scared and anxious * Alone and unsupported * More worried about what's happening This can increase the child's anxiety levels. we can prepare children and parents beforehand about what will happen * Allow parents to be present during anesthesia induction * Use distraction techniques like toys or videos * Use gentle and calm anesthesia induction techniques By doing these things, we can help reduce anxiety in children and make the experience less scary for them.
NCT06612398
The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).
NCT06303843
The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group. Translated with DeepL.com (free version)
NCT05307315
Many patients before the operation feel a high level of anxiety. This felt anxiety can develop due to many reasons such as anesthesia, not being able to wake up from the surgery and being disabled, and fear of feeling pain after the surgery. Music applications, which are among non-pharmacological techniques, are frequently used in the management of pain and anxiety.In this study, the effect of listening to music in the preoperative period on the anxiety of urology patients will be investigated
NCT05208580
The aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. Participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). The investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. Additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety. Impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.
NCT05341531
Perioperative neurocognitive impairment, including postoperative delirium (POD), is common in older patients after anesthesia and surgery and is associated with poorer short- and long-term outcomes, including worsening cognitive decline, surgical Complications, increased risk of hospitalization, and death after cardiac and noncardiac surgery. POD is more common with age, occurs in up to 65% of elderly patients, and increases in patients with mild cognitive impairment. As more and more older adults undergo surgery and anesthesia, POD has become a major global health challenge requiring urgent attention. Prevention strategies involving multidisciplinary perioperative interventions may have some benefit overall, but the impact on POD remains uncertain. Known inflammatory responses may be associated with adverse outcomes such as neurocognitive dysfunction and cancer recurrence after major surgery. Different anesthesia methods, the regulation of anesthesia drugs on postoperative inflammatory response has been confirmed in vitro, but its clinical significance is still unclear. Therefore, exploring the risk factors of inducing POD has important clinical significance for the early prevention of POD. Second, a recent study found that the incidence of POD was significantly higher in patients whose sleep cycle was disturbed during hospitalization. Animal experiments found that after 5 hours of sleep deprivation in adult mice, the number of dendritic spines in CA1 neurons in the hippocampus was reduced, and the length of dendrites was significantly shortened, which damaged the synaptic transmission of the central nervous system, and significantly improved memory and cognitive function. Damaged. And many studies have investigated whether bispectral index (BIS)-guided anesthesia is associated with a reduced risk of POD, compared with "standard-of-care" anesthesia or the use of goal-directed end-tidal volatile agent concentrations, the reasoning is that the use of BIS-guided anesthesia results in less anesthesia exposure, and therefore "light" anesthesia may reduce the incidence of postoperative POD compared to "deep" anesthesia. However, this conclusion is still controversial. The study of Anshentong et al. has confirmed that deep anesthesia with BIS maintained at 40-49 can delay postoperative recovery time, reduce the level of inflammatory factors and the incidence of early postoperative cognitive impairment, and reduce the incidence of early postoperative cognitive impairment. Brain damage. Therefore, although age is known to be the main correlative factor for POD, different depths of anesthesia may cause different stress responses in patients, resulting in different release of inflammatory factors. An additional risk factor may be preoperative psychiatric symptoms, and assessment of mental status is often overshadowed by concerns about multiple comorbidities in older adults. Anxiety disorders are one of the prominent psychiatric symptoms in older adults. very common. Preoperative anxiety is defined as an unpleasant restless or tense state secondary to patient concerns about illness, hospitalization, anesthesia, surgery, or the unknown. Studies on the relationship between preoperative anxiety and POD also vary in consistency due to the characteristics of different populations. Many of the current studies are mostly single-center with limited sample size, which may have a certain bias in the conclusions. Therefore, the investigators designed and planned to conduct a multi-center, large-sample cohort study to determine the impact of perioperative related factors and inflammatory markers on elderly patients undergoing non-cardiac major surgery .
NCT05285995
As a very threatening stressor, surgery often leads to strong psychological stress reactions in surgical patients before surgery, the most typical of which is anxiety. According to previous studies, more than 60% of children have severe anxiety during induction of anesthesia. Preoperative anxiety in children is not only significantly related to postoperative adverse physiological and psychological changes such as delirium during recovery from anesthesia, postoperative pain, and sleep disturbance, but also has a serious negative impact on their future study and life (such as timidity, nocturia, etc.), even for several years. Moreover, if the child is uncooperative, crying violently, and refuses to enter the operating room due to preoperative psychological stress, coercive measures are often adopted in clinical practice, which can easily cause harm to the physical and mental health of the child. Therefore, effective interventions to reduce pre-operative anxiety in children is an urgent need. At present, most researches adopt different interventions to improve the preoperative anxiety of children. Several studies have explored to the efficacy of psychological interventions and virtual reality exposure in reducing preoperative anxiety in children undergoing surgery,results suggest that these interventions can reduce preoperative anxiety and postoperative pain in children. Through toys and video games, researchers verified the effects of psychological preparation on perioperative stress, anxiety, and mood in children undergoing cardiac surgery. In addition, researchers also conducted specialized games, interest induction, childlike and diversified nursing methods to relieve preoperative anxiety in children. Although these interventions have achieved certain effects, the intervention strategies need professionals accompanied and special arrangements, there also exist problems such as time-consuming, labor-intensive, and limited audience, especially during the peak operation period. Attention distraction is an emotion regulation strategy commonly used in daily life, which actively separates the individual's attention from negative emotions and points to neutral or positive stimuli. Music and animation are the most common and affordable distraction strategies to reduce preoperative anxiety in children, but their effects are inconsistent. It is worth noting that Chow believe that the effect of the combination of audio and video is better than that of music intervention. Moreover, previous studies confirmed that when a mental image is experienced, there is an associated emotion that connects the feeling state with the mind and body leading to a physiologic change. Therefore, this study intends to use two distraction strategies (music and animation) in pediatric surgery patients to compare the effects of the two strategies on preoperative anxiety, anesthesia induction cooperation, vital signs, and to explore effective methods to improve preoperative anxiety in children. This study was a randomized controlled trial according to the CONSORT guidelines.Researchers recruited child patients(3-12 years) from a general tertiary hospital in Changsha, Hunan province, China. Researchers divided the subjects into three groups, animation group, music group and control group. The 181 patients recruited were randomized into three groups. Instruments, including preoperative anxiety,the degree of cooperation of children during anesthesia induction ,heart rate and blood pressure were assessed at the three moments: before entering the operating room (baseline T0), entering the operating room(T1), and before induction of anesthesia(T2). The repeated-measures analysis of variance were used to analyze the data.
NCT04690764
Most patients have varying degrees of anxiety and fear before surgery. We believe that preopertive anxiety levels have an effect on intraoperative hemodynamics and recovery and affect intraoperative drug consumption. Inspired by this idea, we aimed to evaluate the effects of preoperative anxiety on hemodynamics, recovery, and drug consumption in patients undergoing total intravenous anesthesia (TIVA) due to neuromuscular monitoring.