Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 175
- 主要终点
- Generalized Anxiety Disorder Scale (GAD-7)
研究概览
简要总结
The main objective of this clinical trial is to evaluate whether watching an educational video before surgery, combined with the use of virtual reality or music during surgery, can reduce anxiety and pain in people undergoing ingrown toenail (onychocryptosis) surgery.
The main questions the study aims to answer are:
Are the educational video, virtual reality, and music effective in controlling and reducing pain and anxiety during surgery compared to traditional surgery?
As a distraction technique, is virtual reality or music more effective in reducing pain and anxiety during surgery?
Do these interventions produce changes in patients' physiological parameters during surgery?
Is there a relationship between patients' sociodemographic characteristics and their level of anxiety when undergoing surgery?
Three study groups will be compared to determine the effect of each intervention:
Experimental Group 1: watch a 5-minute educational video before entering the operating room and use virtual reality glasses with a 360° immersive video of a relaxing walk in the forest during surgery.
Experimental Group 2: watch the 5-minute educational video before surgery and listen to carefully selected instrumental music through noise-canceling headphones during surgery.
Control Group: surgery performed in the traditional way, without an educational video, virtual reality, or music.
All participants will complete questionnaires to assess anxiety, pain, and satisfaction before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older of any sex.
- •Diagnosed with ingrown toenail (onychocryptosis) requiring surgical treatment.
- •Cognitive ability to understand study information, follow instructions, and complete questionnaires.
排除标准
- •Patients requiring ingrown toenail surgery associated with another pathology or surgical technique (e.g., subungual exostosis, chondroma, foreign bodies, tenotomies, etc.).
- •Patients with difficulties understanding Spanish.
- •Patients with visual or auditory disabilities preventing full use of the educational video, virtual reality, or headphones.
- •Patients with a diagnosis of trait anxiety, depression, or any emotional disorder.
- •Patients under psychiatric treatment.
- •Patients with chronic foot pain.
- •Patients receiving treatment for chronic pain.
- •Patients with epilepsy.
- •Patients with severe vertigo.
- •Patients with current facial injuries or burns.
- •Patients under treatment for blood pressure.
- •Patients with coagulation disorders.
- •Patients with active infections.
- •Pregnant women.
结局指标
主要结局
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: The scale will be completed by patients after viewing the educational video and before entering the operating room.
The Generalized Anxiety Disorder Scale (GAD-7) is a brief questionnaire consisting of 7 questions designed to identify symptoms associated with generalized anxiety disorder. The questions refer to the last 15 days and are answered using a 4-point Likert scale (0 = not at all, 3 = nearly every day), with a maximum score of 21. Based on the final score, anxiety levels are classified into four categories: 0-4 (minimal), 5-9 (mild), 10-14 (moderate), and 15-21 (severe). In this study, the GAD-7 will be used to analyze the relationship between higher preoperative and intraoperative anxiety and the presence of generalized anxiety disorder.
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: The scale will be completed by patients after viewing the educational video and before entering the operating room.
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-administered 6-item questionnaire that evaluates preoperative anxiety and the patient's need for information regarding surgery. It consists of two subscales: APAIS-A (items 1, 2, 4, and 5), which measures anxiety with scores ranging from 4 (not anxious) to 20 (maximum anxiety), and APAIS-I (items 3 and 6), which measures the need for information and is classified into three levels: 2-4 (no additional information needed), 5-7 (moderate need), and 8-10 (high need). Each item is rated on a 5-point Likert scale, where 1 = "Not at all" and 5 = "Extremely," allowing to obtain clear information from surgical patients about both their level of anxiety and their need for information in the preoperative phase.
Preoperative Visual Analogue Scale for Anxiety (VAS-A pre)
时间窗: Measured once after viewing the educational video and prior to entering the operating room.
The Visual Analogue Scale for Anxiety (VAS-A) is a single-item tool used to assess anxiety. It consists of a 10 cm horizontal line anchored with the descriptors "not anxious at all" on the left end and "extremely anxious" on the right end. Patients are asked to place a mark on the line corresponding to their current level of anxiety. The score is obtained by measuring in millimeters from the left end of the line to the patient's mark, resulting in a range from 0 to 100, where higher values indicate greater anxiety. The VAS-A pre will be used to evaluate the patient's preoperative anxiety.
Intraoperative Visual Analogue Scale for Anxiety (VAS-A intra)
时间窗: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
The Visual Analogue Scale for Anxiety (VAS-A) is a single-item tool used to assess anxiety. It consists of a 10 cm horizontal line anchored with the descriptors "not anxious at all" on the left end and "extremely anxious" on the right end. Patients are asked to place a mark on the line corresponding to their current level of anxiety. The score is obtained by measuring in millimeters from the left end of the line to the patient's mark, resulting in a range from 0 to 100, where higher values indicate greater anxiety. The VAS-A intra will be used to evaluate the patient's anxiety during the surgical procedure. To preserve the immersive experience in the operating room, this questionnaire will be completed after the surgery, but the scale clearly instructs the patient to report how they felt during the procedure
Postoperative Visual Analogue Scale for Anxiety (VAS-A post)
时间窗: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
The Visual Analogue Scale for Anxiety (VAS-A) is a single-item tool used to assess anxiety. It consists of a 10 cm horizontal line anchored with the descriptors "not anxious at all" on the left end and "extremely anxious" on the right end. Patients are asked to place a mark on the line corresponding to their current level of anxiety. The score is obtained by measuring in millimeters from the left end of the line to the patient's mark, resulting in a range from 0 to 100, where higher values indicate greater anxiety. The VAS-A post will be used to evaluate the patient's anxiety after the surgical procedure.
State-Trait Anxiety Inventory - State-Anxiety Subscale (STAI-S)
时间窗: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
The State-Anxiety subscale reflects a transient emotional condition, measuring the anxiety experienced at the present moment. It consists of 20 items, each rated on a 4-point Likert scale according to the intensity of perceived anxiety: 0 ("Almost never/Not at all"), 1 ("Somewhat/Sometimes"), 2 ("Moderately/Often"), and 3 ("Very much/Almost always"). Total scores range from 0 to 60. In this study, the STAI-State subscale will be used exclusively, as we aim to assess the anxiety experienced by the patient at the time of surgery. To preserve the immersive experience in the operating room, this questionnaire will be completed after the surgery, but the scale clearly instructs the patient to report how they felt during the procedure.
Visual Analogue Scale for Maximum Pain (VAS-P Max)
时间窗: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
The Visual Analogue Scale for Pain (VAS-P) is a single-item tool used to assess pain intensity. It consists of a 10 cm horizontal line anchored with the descriptors "no pain" on the left end and "worst imaginable pain" on the right end. Patients are asked to place a mark on the line corresponding to their pain level. The score is obtained by measuring in millimeters from the left end of the line to the patient's mark, resulting in a range from 0 to 100, where higher values indicate greater pain. VAS-P Max will be used to record the highest level of pain experienced by the patient during surgery. To preserve the immersive experience in the operating room, this scale will be completed after the surgery, but the scale clearly instructs the patient to report how they felt during the procedure.
Visual Analogue Scale for Average Pain (VAS-P average)
时间窗: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
The Visual Analogue Scale for Pain (VAS-P) is a single-item tool used to assess pain intensity. It consists of a 10 cm horizontal line anchored with the descriptors "no pain" on the left end and "worst imaginable pain" on the right end. Patients are asked to place a mark on the line corresponding to their pain level. The score is obtained by measuring in millimeters from the left end of the line to the patient's mark, resulting in a range from 0 to 100, where higher values indicate greater pain. VAS-P Average will be used to record the average pain experienced by the patient throughout the surgical procedure. To preserve the immersive experience in the operating room, this scale will be completed after the surgery, but the scale clearly instructs the patient to report how they felt during the procedure.
次要结局
- Preoperative Heart Rate(Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.)
- Postoperative Heart Rate(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Postoperative Oxygen Saturation(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Preoperative Systolic Blood Pressure(Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.)
- Preoperative Diastolic Blood Pressure(Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.)
- Preoperative Oxygen Saturation(Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.)
- Intraoperative Systolic Blood Pressure(Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.)
- Intraoperative Diastolic Blood Pressure(Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.)
- Intraoperative Heart Rate(Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.)
- Intraoperative Oxygen Saturation(Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.)
- Postoperative Systolic Blood Pressure(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Postoperative Diastolic Blood Pressure(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Satisfaction with Received Information(Measured once, immediately before entering the operating room.)
- Satisfaction with Educational Video(Measured once, after reviewing the educational video and before entering the operating room.)
- Satisfaction with Surgical Procedure(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Satisfaction with Anesthesia(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Satisfaction with Virtual Reality(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
- Satisfaction with Music Therapy(Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.)
研究者
Raquel Prieto Domínguez
University Degree in Podiatry
University of Seville