NCT06728163 Impact of Virtual Reality (VR) and Music Intervention
| NCT ID | NCT06728163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | General Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-03-06 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is as follows.The purpose of this study is as follows. First, it aims to examine the differences in anxiety, depression, and sleep quality based on the inclusion of a music intervention during relaxation induction in the VR-based surgical education process for patients aged 20 to 65 undergoing gynecological surgery under general anesthesia. Second, it seeks to assess the impact of using virtual reality (VR) tools in preoperative education on patients' understanding of the surgical process and their satisfaction with the education. For patients aged 20 to 65, classified as physical status 1-3 according to the American Society of Anesthesiologists (ASA) undergoing gynecological surgery under general anesthesia, educational materials related to the surgical process to be provided on the day of surgery will be created in two formats: written educational materials and virtual reality (VR) educational materials. The VR educational materials will include a relaxation-inducing breathing intervention protocol aimed at reducing anxiety. The intervention will be divided into two groups: one using verbal instructions and the other using music intervention, creating a total of four conditions. These conditions will then be provided to the four groups, which are randomly assigned prior to surgery, to investigate whether there is a difference in preoperative anxiety, depression, and sleep quality based on the music intervention during the relaxation induction. Additionally, we aim to assess whether the provision of relaxation therapy via breathing exercises through the use of VR during the surgical education process affects patients' understanding of the surgical process and their satisfaction with the education.
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria: Patients aged 20 to 65 undergoing gynecological surgery under general anesthesia, classified as physical status 1-3 according to the American Society of Anesthesiologists (ASA). Exclusion Criteria: * Patients whose surgery has been canceled * Patients with cognitive impairment * Patients with hearing or visual impairments * Patients with any condition that, in the investigator's judgment, may compromise the well-being of the patient or the integrity of the study * Individuals who are unable to read the consent form (e.g., illiterate or non-native speakers)
Frequently Asked Questions
Who can join the NCT06728163 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 65 Years, studying General Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06728163 currently recruiting?
Yes, NCT06728163 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yonsei University to inquire about joining.
Where is the NCT06728163 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06728163 clinical trial?
NCT06728163 is sponsored by Yonsei University. The trial plans to enroll 140 participants.