Impact of Virtual Reality (VR) and Music Intervention

Yonsei University

Status: Enrolling

Conditions: General Anesthesia

Treatments: Other: VR educational material + breathing relaxation with verbal instruction; Other: written educational material + breathing relaxation with music intervention.; Other: VR educational material + breathing relaxation with music intervention; Other: written education group

Study type: Interventional

Funder types: Other

Identifiers

NCT06728163

4-2023-1499

Details and patient eligibility

About

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.

Full description

This study, the decision to register patients aged 20 to 65 undergoing gynecological surgery under general anesthesia will be made after obtaining consent from the patient's attending gynecologist. Patients will be informed of the study's purpose and methods in a private space, such as a consultation room in the ward or the outpatient surgery room. After at least one hour, patients who understand the study and agree to participate will be asked to provide written consent. Screening will be conducted for those who agree to participate, and patients meeting the inclusion criteria will be finally registered for the study. Double-blinding for group allocation will not be possible, and the study will proceed as a randomized prospective trial. The study coordinator (research nurse) will assign patients to the control group (written education group) and three experimental groups (VR + breathing relaxation with verbal instructions, VR + breathing relaxation with music intervention, written education + breathing relaxation with music intervention) based on a random allocation table generated using Excel. Group assignments will be made using the randomization table depending on who performs the registration.

Enrollment: 140 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 4 patient groups

Written Education

Active Comparator group

Description:

All procedures are conducted according to surgery protocol.Patients will receive education on the previous day before surgery, the surgery team will receive education from the previous day.The group receives written education to patients before surgery.

Treatment:

Other: written education group

VR Educational Materials and Breathing Relaxation Language Intervention

Experimental group

Description:

All procedures are carried out in accordance with the surgical protocol of Severance Hospital. Patients will receive training from the research team on the surgical procedure they will undergo on the day before the operation. The group will receive VR training materials and Verbal (non-music)-guided breathtaking instructions via VR on the day before the operation.

Treatment:

Other: VR educational material + breathing relaxation with verbal instruction

VR Educational Materials and Breathing Relaxation Music Intervention

Experimental group

Description:

All procedures are performed in accordance with the surgical protocols of Severance Hospital. Patients will receive training from the research team on the surgical procedure they will undergo on the day before the operation. The group will receive VR training materials and music-guided bridging instructions via VR on the day before the operation.

Treatment:

Other: VR educational material + breathing relaxation with music intervention

Written Educational Materials and Breathing Relaxation Music Intervention

Experimental group

Description:

All procedures are performed in accordance with the surgical protocols of Severance Hospital. Patients will receive training from the research team on the surgical procedure to be performed on the day before the operation. The group will receive written training materials and music-guided bridging instructions via VR on the day before the operation.

Treatment:

Other: written educational material + breathing relaxation with music intervention.