Impact of Virtual Reality (VR) and Music Intervention

NCT06728163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • General Anesthesia

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 for about 3 minutes and 3 seconds.

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 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.

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728163 on ClinicalTrials.gov