Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery

NCT07214116 | Not Yet Recruiting

• 1 other identifier: SICEIA-2025-1206
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ingrown Toenail

Keywords

Ingrown toenail; Onychocryptosis; Virtual reality; Music therapy; Educational video; Podiatry; Pain management; preoperative anxiety

Outcome Measures

Primary Outcomes (8)

• 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 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)

  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.

  The scale will be completed by patients after viewing the educational video and before entering the operating room.

• 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.

  Measured once after viewing the educational video and prior to entering the operating room.

• 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

  Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.

• Postoperative Visual Analogue Scale for Anxiety (VAS-A post)

  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.

  Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.

• State-Trait Anxiety Inventory - State-Anxiety Subscale (STAI-S)

  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.

  Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.

• Visual Analogue Scale for Maximum Pain (VAS-P Max)

  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.

  Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.

• Visual Analogue Scale for Average Pain (VAS-P average)

  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.

  Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.

Secondary Outcomes (18)

• 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 Heart Rate

  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.

Study Arms (3)

Control group

NO INTERVENTION

Participants undergo traditional onychocryptosis surgery without educational video, music, or virtual reality.

Experimental group 1

EXPERIMENTAL

Participants watch an educational video before the surgery and use virtual reality glasses during the onychocryptosis surgery.

Behavioral: Educational Video; Device: Virtual Reality

Experimental group 2

EXPERIMENTAL

Participants watch an educational video before the surgery and listen to music through headphones during the onychocryptosis surgery.

Behavioral: Educational Video; Behavioral: Music Therapy

Interventions

Educational Video BEHAVIORAL

The 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.

Experimental group 1; Experimental group 2

Virtual Reality DEVICE

Participants 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.

Also known as: VR, Virtual reality glasses, VR glasses, VR headset, Virtual reality headset

Experimental group 1

Music Therapy BEHAVIORAL

Participants 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.

Also known as: Music listening

Experimental group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Nails, Ingrown; Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Degree in Podiatry

Model Details: Randomized, parallel assignment with three groups: (1) Control group receiving standard care without educational video, music, or virtual reality; (2) Experimental group 1 receiving an educational video combined with virtual reality; (3) Experimental group 2 receiving an educational video combined with music therapy. Groups will be compared to evaluate effectiveness in reducing anxiety and pain in onychocryptosis surgery.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10