Impact of Virtual Reality (VR) and Music Intervention

Not Applicable

Recruiting

• Conditions: General Anesthesia

• Registration Number: NCT06728163
• Lead Sponsor: Yonsei University

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.

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.

Study Timeline

• Study Start: 2024-03-06
• Study First Submitted: 2024-10-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
K-POMS Anxiety/Depression	Baseline (pre-operative), Post-Operative Day 0 (operation day)	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").
K-RCSQ (Sleep in the ICU Questionnaire)	Baseline (pre-operative), Post-Operative Day 0 (operation day)	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.

Secondary Outcome Measures

Name	Time	Method
Understanding of the Explanation : Likert	Baseline (pre-operative)	Understanding of the explanation and educational satisfaction: These are based on a satisfaction assessment tool for web-based virtual classes developed by Im Jeong-hoon and Jeong In-seong (1999), which was modified and improved by Choi Mi-hee (2015) to evaluate the satisfaction of smartphone-based colonoscopy bowel preparation video education. Out of the 12 items in the original tool, 7 items that can be evaluated simultaneously with a written tool were used. The original tool measures aspects such as the appropriateness of educational content, methods, design, material organization, interest, and understanding, with a total of 12 items. It uses a 4-point scale (1: Not at all, 4: Very much), where higher scores indicate higher satisfaction. The reliability of the tool at the time of development was Cronbach's α = 0.84, and in Choi Mi-hee's study (2015), the reliability was Cronbach's α = 0.93. The evaluation takes approximately 3 minutes.
Educational Satisfaction : VAS	Baseline (pre-operative)	Understanding of the explanation and educational satisfaction: These are based on a satisfaction assessment tool for web-based virtual classes developed by Im Jeong-hoon and Jeong In-seong (1999), which was modified and improved by Choi Mi-hee (2015) to evaluate the satisfaction of smartphone-based colonoscopy bowel preparation video education. Out of the 12 items in the original tool, 7 items that can be evaluated simultaneously with a written tool were used. The original tool measures aspects such as the appropriateness of educational content, methods, design, material organization, interest, and understanding, with a total of 12 items. It uses a 4-point scale (1: Not at all, 4: Very much), where higher scores indicate higher satisfaction. The reliability of the tool at the time of development was Cronbach's α = 0.84, and in Choi Mi-hee's study (2015), the reliability was Cronbach's α = 0.93. The evaluation takes approximately 3 minutes.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of