Impact of Virtual Reality (VR) and Music Intervention

Official title

The Impact of Virtual Reality (VR) and Music Intervention During Preoperative Anxiety, Comprehension of Medical Explanations, and Satisfaction During Preoperative Training for Gynecology Surgical Patients Under General Anesthesia

Overview

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.

Detailed 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.

Interventions

• Other written education group
  group will receive standard preoperative guidelines as common educational materials. A written notice related to surgery that was previously used in the ward is provided.
• Other VR educational material + breathing relaxation with verbal instruction
  group will receive standard preoperative guidelines as common educational materials. The VR-based educational materials and relaxation videos will utilize custom video content developed by Film Factory. The educational content involves a visual guide, where the patient, using a VR headset, is walked through the process of entering the operating room while listening to an explanation from the operating surgeon, which takes approximately 3 minutes. Verbal instructions for breathing are provided fo
• Other VR educational material + breathing relaxation with music intervention
  group will receive standard preoperative guidelines as common educational materials. The VR-based educational materials and relaxation videos will utilize custom video content developed by Film Factory. The educational content involves a visual guide, where the patient, using a VR headset, is walked through the process of entering the operating room while listening to an explanation from the operating surgeon, which takes approximately 3 minutes. The relaxation intervention, which provides instr
• Other written educational material + breathing relaxation with music intervention.
  group will receive standard preoperative guidelines as common educational materials. A written notice related to surgery that was previously used in the ward is provided. The relaxation intervention, which provides instructions for calming the breath, lasts about 4 minutes and 32 seconds. After the intervention, an audio file in the form of a QR code will be provided, allowing participants to listen to it repeatedly at their discretion.

Primary outcome measures

• K-POMS Anxiety/Depression [Time frame: Baseline (pre-operative), Post-Operative Day 0 (operation day)]
• K-RCSQ (Sleep in the ICU Questionnaire) [Time frame: Baseline (pre-operative), Post-Operative Day 0 (operation day)]

Secondary outcome measures (2)

• Understanding of the Explanation : Likert [Time frame: Baseline (pre-operative)]
• Educational Satisfaction : VAS [Time frame: Baseline (pre-operative)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

South Korea · 1 center

• Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT06728163 · 4-2023-1499

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗