Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery
| Registry | NCT07214116 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 175 (Estimated) |
| Sponsor | University of Seville (Other) |
| Conditions | Ingrown Toenail |
| Interventions | Educational Video, Virtual Reality, Music Therapy (Behavioral, device) |
| Dates | start 2025-10-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2025-10-09, last updated 2025-10-09 |
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All trials for Ingrown Toenail All trials of Educational Video All trials of Virtual Reality
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 Reality | Participants 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 Therapy | Participants watch an educational video before the surgery and listen to music through headphones during the onychocryptosis surgery. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.