Clinical trial NCT06728163: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Anesthesia
Keywords: gynecology surgical patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: K-POMS Anxiety/Depression
timeFrame: Baseline (pre-operative), Post-Operative Day 0 (operation day)
measure: K-RCSQ (Sleep in the ICU Questionnaire)
timeFrame: Baseline (pre-operative), Post-Operative Day 0 (operation day)
Secondary outcomes:
measure: Understanding of the Explanation : Likert
timeFrame: Baseline (pre-operative)
measure: Educational Satisfaction : VAS
timeFrame: Baseline (pre-operative)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References: