Ingrown ToenailNCT07214116
Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery
A study testing Educational Video, Virtual Reality and Music Therapy in people with Ingrown Toenail, run by University of Seville.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ingrown Toenail
- What is being tested?
- Educational Video, Virtual Reality and Music Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery
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:
Read more
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
- Being tested
- Educational Video, Virtual Reality, Music Therapy
- Keywords
- Ingrown toenail, Onychocryptosis, Virtual reality, Music therapy, Educational video, Podiatry, Pain management, preoperative anxiety
- Medical subject headings
- Nails, Ingrown, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoBehavioural
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.
Virtual RealityDevice
Also called VR, Virtual reality glasses, VR glasses, VR headset
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.
Music TherapyBehavioural
Also called Music listening
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Video; Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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: 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: 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: 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: 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: 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: 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
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.
Measured: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
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.
Measured: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
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.
Measured: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
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.
Measured: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
Intraoperative Systolic Blood Pressure
Systolic blood pressure (mmHg) will be measured using a validated automatic blood pressure monitor at four predefined moments during the surgery: (1) disinfection of the surgical area, (2) application of local anesthesia, (3) first incision or invasive technique, and (4) final bandaging. This will allow monitoring of hemodynamic changes during the procedure.
Measured: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Diastolic Blood Pressure
Diastolic blood pressure (mmHg) will be measured using a validated automatic blood pressure monitor at four predefined moments during the surgery: (1) disinfection of the surgical area, (2) application of local anesthesia, (3) first incision or invasive technique, and (4) final bandaging. This will allow monitoring of hemodynamic changes during the procedure.
Measured: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Heart Rate
Heart rate (beats per minute) will be measured using a validated automatic monitor at four predefined moments during the surgery: (1) disinfection of the surgical area, (2) application of local anesthesia, (3) first incision or invasive technique, and (4) final bandaging. This will allow monitoring of cardiovascular response during the procedure.
Measured: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Oxygen Saturation
Oxygen saturation (%) will be measured using a validated pulse oximeter at four predefined moments during the surgery: (1) disinfection of the surgical area, (2) application of local anesthesia, (3) first incision or invasive technique, and (4) final bandaging. This will allow monitoring of respiratory function during the procedure.
Measured: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Postoperative Systolic Blood Pressure
Systolic blood pressure (mmHg) will be measured using a validated automatic blood pressure monitor once the patient has exited the operating room and is in the pre-recovery area. This measurement will assess the patient's hemodynamic status immediately after the surgery.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Diastolic Blood Pressure
Diastolic blood pressure (mmHg) will be measured using a validated automatic blood pressure monitor once the patient has exited the operating room and is in the pre-recovery area. This measurement will assess the patient's hemodynamic status immediately after the surgery.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Heart Rate
Heart rate (beats per minute) will be measured using a validated automatic monitor once the patient has exited the operating room and is in the pre-recovery area. This measurement will assess the patient's cardiovascular response immediately after the surgery.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Oxygen Saturation
Oxygen saturation (%) will be measured using a validated pulse oximeter once the patient has exited the operating room and is in the pre-recovery area. This measurement will assess the patient's respiratory status immediately after the surgery.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Received Information
Participants will rate their satisfaction with the information they have received regarding the surgical procedure using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure will capture the patient's perception of the adequacy and clarity of preoperative information.
Measured: Measured once, immediately before entering the operating room.
Satisfaction with Educational Video
Participants in the experimental groups will rate their satisfaction with the educational video they have viewed prior to the surgery using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure assesses the participant's perception of the video's usefulness and clarity. Participants in the control group will not complete this measure, as they will not have viewed the video.
Measured: Measured once, after reviewing the educational video and before entering the operating room.
Satisfaction with Surgical Procedure
Participants will rate their satisfaction with the surgical procedure they have just undergone using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure captures the patient's perception of the quality and outcome of the surgery.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Anesthesia
Participants will rate their satisfaction with the anesthesia administered during the surgical procedure using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure captures the patient's perception of comfort and adequacy of anesthesia.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Virtual Reality
Participants in the experimental group 1 will rate their satisfaction with the use of virtual reality glasses during the surgical procedure using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure assesses the participant's experience and comfort with the virtual reality intervention. Participants in other groups will not complete this measure.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Music Therapy
Participants in the experimental group 2 will rate their satisfaction with listening to music during the surgical procedure using a 5-point Likert scale (1 = Not satisfied at all, 2 = Slightly satisfied, 3 = Neutral, 4 = Very satisfied, 5 = Completely satisfied). This measure captures the participant's experience and comfort with the music intervention. Participants in other groups will not complete this measure.
Measured: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Prieto Domínguez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214116
- Sponsor's protocol ID
- SICEIA-2025-1206
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery
- ClinicalTrials.gov ID
- NCT07214116
- Acronym / sponsor ID
- SICEIA-2025-1206
- Conditions
- Ingrown Toenail
- Keywords
- Ingrown toenail, Onychocryptosis, Virtual reality, Music therapy, Educational video, Podiatry, Pain management, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants undergo traditional onychocryptosis surgery without educational video, music, or virtual reality. |
| Experimental group 1 | Experimental | Behavioral: Educational Video, Device: Virtual RealityParticipants watch an educational video before the surgery and use virtual reality glasses during the onychocryptosis surgery. |
| Experimental group 2 | Experimental | Behavioral: Educational Video, Behavioral: Music TherapyParticipants watch an educational video before the surgery and listen to music through headphones during the onychocryptosis surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational VideoThe 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. | Behavioural | Experimental group 1, Experimental group 2 |
| Virtual RealityAlso: VR, Virtual reality glasses, VR glasses, VR headsetParticipants 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. | Device | Experimental group 1 |
| Music TherapyAlso: Music listeningParticipants 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. | Behavioural | Experimental group 2 |
Primary outcome
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
18 secondary outcomes
Preoperative Systolic Blood Pressure
Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
Preoperative Diastolic Blood Pressure
Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
Preoperative Heart Rate
Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
Preoperative Oxygen Saturation
Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.
Intraoperative Systolic Blood Pressure
Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Diastolic Blood Pressure
Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Heart Rate
Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Intraoperative Oxygen Saturation
Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.
Postoperative Systolic Blood Pressure
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Diastolic Blood Pressure
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Heart Rate
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Postoperative Oxygen Saturation
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Received Information
Time frame: Measured once, immediately before entering the operating room.
Satisfaction with Educational Video
Time frame: Measured once, after reviewing the educational video and before entering the operating room.
Satisfaction with Surgical Procedure
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Anesthesia
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Virtual Reality
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Satisfaction with Music Therapy
Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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P : Ingrown Toenail Patient I : Bird Flap Surgery C : Noel Winograd Method O : Recurrence, Complications, Functional Outcome, Pain,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video, Virtual Reality and Music Therapy in people with Ingrown Toenail, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Scale (GAD-7) (time frame: The scale will be completed by patients after viewing the educational video and before entering the operating room.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.