RecruitingNot ApplicableNCT06728163

Impact of Virtual Reality (VR) and Music Intervention

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


Sponsor

Yonsei University

Enrollment

140 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 20 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using virtual reality (VR) or listening to music before and during gynecological surgery can reduce anxiety and pain, and improve overall patient experience compared to standard care. **You may be eligible if...** - You are between 20 and 65 years old - You are having gynecological surgery under general anesthesia - You are classified as ASA physical status 1 to 3 (meaning you are in generally good to moderately compromised health) **You may NOT be eligible if...** - Your surgery has been canceled - You have a cognitive impairment (memory or thinking problems) - You have hearing or vision impairments that would interfere with the VR or music intervention - You cannot read the consent form (for example, due to being unable to read or not speaking the local language) - Your doctor believes participating would compromise your wellbeing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERwritten 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.

OTHERVR 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.

OTHERVR 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.

OTHERwritten 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.


Locations(1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT06728163


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