General AnesthesiaNCT06728163
Impact of Virtual Reality (VR) and Music Intervention
A study testing written education group, VR educational material + breathing relaxation with verbal instruction and VR educational material + breathing relaxation with music intervention in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- written education group, VR educational material + breathing relaxation with verbal instruction and VR educational material + breathing relaxation with music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jeongmin Kim, M.D., Ph.D., +82 10-8926-2684, ANESJEONGMIN@yuhs.ac
About this study
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
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.
Read the 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.
- Conditions
- General Anesthesia
- Being tested
- written education group, VR educational material + breathing relaxation with verbal instruction, VR educational material + breathing relaxation with music intervention, written educational material + breathing relaxation with music intervention.
- Keywords
- gynecology surgical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written education groupOther
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.
VR educational material + breathing relaxation with verbal instructionOther
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 material + breathing relaxation with music interventionOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: written educational material + breathing relaxation with music intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: Baseline (pre-operative), Post-Operative Day 0 (operation day)
Secondary outcomes (2)
Understanding of the Explanation : Likert
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.
Measured: Baseline (pre-operative)
Educational Satisfaction : VAS
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.
Measured: Baseline (pre-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start6 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728163
- Sponsor's protocol ID
- 4-2023-1499
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06728163
- Acronym / sponsor ID
- 4-2023-1499
- Conditions
- General Anesthesia
- Keywords
- gynecology surgical patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Written Education | Active comparator | Other: written education groupAll 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. |
| VR Educational Materials and Breathing Relaxation Language Intervention | Experimental | Other: VR educational material + breathing relaxation with verbal instructionAll 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. |
| VR Educational Materials and Breathing Relaxation Music Intervention | Experimental | Other: VR educational material + breathing relaxation with music interventionAll 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. |
| Written Educational Materials and Breathing Relaxation Music Intervention | Experimental | Other: written educational material + breathing relaxation with music intervention.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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| written education groupgroup 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 | Written Education |
| VR educational material + breathing relaxation with verbal instructiongroup 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 Materials and Breathing Relaxation Language Intervention |
| VR educational material + breathing relaxation with music interventiongroup 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 | VR Educational Materials and Breathing Relaxation Music Intervention |
| 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. | Other | Written Educational Materials and Breathing Relaxation Music Intervention |
Primary outcome
K-POMS Anxiety/Depression
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Understanding of the Explanation : Likert
Time frame: Baseline (pre-operative)
Educational Satisfaction : VAS
Time frame: Baseline (pre-operative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing written education group, VR educational material + breathing relaxation with verbal instruction and VR educational material + breathing relaxation with music intervention in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-POMS Anxiety/Depression (time frame: Baseline (pre-operative), Post-Operative Day 0 (operation day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.