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

University of Seville

Status: Not yet enrolling

Conditions: Ingrown Toenail

Treatments: Device: Virtual Reality; Behavioral: Educational Video; Behavioral: Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07214116

SICEIA-2025-1206

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 3 patient groups

Control group

No Intervention group

Description:

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

Experimental group 1

Experimental group

Description:

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

Treatment:

Behavioral: Educational Video

Device: Virtual Reality

Experimental group 2

Experimental group

Description:

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

Treatment:

Behavioral: Music Therapy

Behavioral: Educational Video