Impact of Virtual Reality (VR) and Music Intervention

NCT06728163 | Recruiting DMC

• 1 other identifier: 4-2023-1499
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

gynecology surgical patients

Outcome Measures

Primary Outcomes (2)

• K-POMS Anxiety/Depression

  K-POMS Anxiety/Depression : This scale calculates scores based on 65 items assessing six subfactors: anxiety, depression, anger, vitality, fatigue, and confusion. For the subfactors, higher scores for vitality are better, while lower scores for the negative psychological factors are better. In this study, 9 items related to anxiety and 15 items related to depression were measured using a 5-point Likert scale (4 points being "strongly agree" and 0 points being "strongly disagree").

  Baseline (pre-operative), Post-Operative Day 0 (operation day)

• K-RCSQ (Sleep in the ICU Questionnaire)

  K-RCSQ (Sleep in the ICU Questionnaire) : This questionnaire consists of 5 items that assess the overall quality of sleep as perceived by the patient. Each item is rated on a scale from 0 to 100, and the average score represents the quality of sleep. Higher scores indicate better sleep quality.

  Baseline (pre-operative), Post-Operative Day 0 (operation day)

Secondary Outcomes (2)

• Understanding of the Explanation : Likert

  Baseline (pre-operative)

• Educational Satisfaction : VAS

  Baseline (pre-operative)

Study Arms (4)

Written Education

ACTIVE COMPARATOR

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.

Other: written education group

VR Educational Materials and Breathing Relaxation Language Intervention

EXPERIMENTAL

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.

Other: VR educational material + breathing relaxation with verbal instruction

VR Educational Materials and Breathing Relaxation Music Intervention

EXPERIMENTAL

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.

Other: VR educational material + breathing relaxation with music intervention

Written Educational Materials and Breathing Relaxation Music Intervention

EXPERIMENTAL

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.

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

Interventions

written education group OTHER

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.

Written Education

VR educational material + breathing relaxation with verbal instruction OTHER

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.

VR Educational Materials and Breathing Relaxation Language Intervention

VR educational material + breathing relaxation with music intervention OTHER

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.

VR Educational Materials and Breathing Relaxation Music Intervention

written educational material + breathing relaxation with music intervention. OTHER

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.

Written Educational Materials and Breathing Relaxation Music Intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: December 11, 2024
• Study Start: March 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)