[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609402":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":12,"centralContacts":12,"locations":12,"responsibleParty":48,"collaborators":12,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":12,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":12,"enrollmentInfo":61,"targetDuration":12,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":79,"whyStopped":12,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":12},{"fullName":5,"class":6},"University of Seville","OTHER",[8,13,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Participants undergo traditional onychocryptosis surgery without educational video, music, or virtual reality.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental group 1","EXPERIMENTAL","Participants watch an educational video before the surgery and use virtual reality glasses during the onychocryptosis surgery.",[18,19],"Behavioral: Educational Video","Device: Virtual Reality",{"label":21,"type":15,"description":22,"interventionNames":23},"Experimental group 2","Participants watch an educational video before the surgery and listen to music through headphones during the onychocryptosis surgery.",[18,24],"Behavioral: Music Therapy",[26,31,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"BEHAVIORAL","Educational Video","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.",[14,21],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Virtual Reality","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.",[14],[37,38,39,40,41],"VR","Virtual reality glasses","VR glasses","VR headset","Virtual reality headset",{"type":27,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Music Therapy","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.",[21],[47],"Music listening",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Raquel Prieto Domínguez","University Degree in Podiatry","100609402","virtual-reality-music-and-education-to-reduce-anxiety-in-patients-undergoing-ingrown-toenail-surgery-100609402",false,"NCT07214116","Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery","Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery","Inclusion Criteria:\n\n* Adults aged 18 years or older of any sex.\n* Diagnosed with ingrown toenail (onychocryptosis) requiring surgical treatment.\n* Cognitive ability to understand study information, follow instructions, and complete questionnaires.\n\nExclusion Criteria:\n\n* Patients requiring ingrown toenail surgery associated with another pathology or surgical technique (e.g., subungual exostosis, chondroma, foreign bodies, tenotomies, etc.).\n* Patients with difficulties understanding Spanish.\n* Patients with visual or auditory disabilities preventing full use of the educational video, virtual reality, or headphones.\n* Patients with a diagnosis of trait anxiety, depression, or any emotional disorder.\n* Patients under psychiatric treatment.\n* Patients with chronic foot pain.\n* Patients receiving treatment for chronic pain.\n* Patients with epilepsy.\n* Patients with severe vertigo.\n* Patients with current facial injuries or burns.\n* Patients under treatment for blood pressure.\n* Patients with coagulation disorders.\n* Patients with active infections.\n* Pregnant women.","ALL","18 Years",{"count":62,"type":63},175,"ESTIMATED","INTERVENTIONAL",[66],"NA","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.\n\nThe main questions the study aims to answer are:\n\nAre the educational video, virtual reality, and music effective in controlling and reducing pain and anxiety during surgery compared to traditional surgery?\n\nAs a distraction technique, is virtual reality or music more effective in reducing pain and anxiety during surgery?\n\nDo these interventions produce changes in patients' physiological parameters during surgery?\n\nIs there a relationship between patients' sociodemographic characteristics and their level of anxiety when undergoing surgery?\n\nThree study groups will be compared to determine the effect of each intervention:\n\nExperimental 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.\n\nExperimental Group 2: watch the 5-minute educational video before surgery and listen to carefully selected instrumental music through noise-canceling headphones during surgery.\n\nControl Group: surgery performed in the traditional way, without an educational video, virtual reality, or music.\n\nAll participants will complete questionnaires to assess anxiety, pain, and satisfaction before and after surgery.",[69],"Ingrown Toenail",[71,72,73,74,75,76,77,78],"Ingrown toenail","Onychocryptosis","Virtual reality","Music therapy","Educational video","Podiatry","Pain management","preoperative anxiety","NOT_YET_RECRUITING","2025-10-02",{"date":82,"type":83},"2025-10-09","ACTUAL",{"date":85,"type":63},"2025-10",{"date":87,"type":63},"2027-01",{"name":5,"class":6}]