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.
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.
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.
Parallel
Educational Video
BehavioralThe educational video will last 5 minutes and is designed to inform participants about the onychocryptosis surgical procedure. The principal investigator will clearly and accessibly explain what the surgery involves, the steps to follow, and what participants can expect before, during, and after the procedure.
Virtual Reality
DeviceParticipants will use Meta Quest 3 VR glasses during the onychocryptosis surgery. The device features adjustable straps, interpupillary distance settings, and built-in headphones with spatial sound, allowing immersive visualization and audio tailored to patient preferences. Disposable masks will be used for hygiene. The immersive content will be a 360-degree video of a relaxing walk through a forest accompanied by gentle music, starting 5 minutes before the procedure. Patients may remove the glasses or stop the VR experience at any time if desired.
Music Therapy
BehavioralParticipants will wear over-ear headphones with disposable covers and noise-cancellation (Bose® QuietComfort 25) connected to an Apple® iPod. Music will start 5 minutes before the ingrown toenail surgery and continue throughout the procedure. Only instrumental classical music, royalty-free and from Musopen.org, will be played in a 1-hour playlist. The same playlist will be used for all participants. Participants can adjust the volume at any time. Music will be temporarily paused if communication with the patient is needed and resumed afterward.
Generalized Anxiety Disorder Scale (GAD-7)
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)
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)
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)
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
Preoperative Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a validated automatic blood pressure monitor, with the patient seated and after 5 minutes of rest. A single value will be recorded prior to the start of surgery to characterize the patient's baseline hemodynamic status.
Preoperative Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a validated automatic blood pressure monitor, with the patient seated and after 5 minutes of rest. A single value will be recorded prior to the start of surgery to characterize the patient's baseline hemodynamic status.
Preoperative Heart Rate
Heart rate will be measured in beats per minute (bpm) using a validated automatic monitor or pulse oximeter, with the patient seated and after 5 minutes of rest. A single value will be recorded prior to the start of surgery to characterize the patient's baseline cardiovascular status.
Preoperative Oxygen Saturation
Oxygen saturation (SpO₂) will be measured as a percentage using a validated pulse oximeter, with the patient seated and after 5 minutes of rest. A single value will be recorded prior to the start of surgery to characterize the patient's baseline respiratory status.
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