Cholecystectomy, LaparoscopicNCT07656246
Effects of VR on Preanesthetic Anxiety
A study testing Virtual Reality Intervention in people with Cholecystectomy, Laparoscopic and Anxiety, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Anxiety, Uncertainty
- What is being tested?
- Virtual Reality Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jun 2026to 31 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Able to communicate in Mandarin Chinese or Taiwanese and complete questionnaires.
- ASA Physical Status I-II.
- Hospitalized one day before surgery.
- No previous experience with general anesthesia.
- Scheduled for laparoscopic cholecystectomy under general anesthesia with endotracheal intubation.
Who cannot join
- Psychiatric disorders.
- Emergency surgery.
- Visual or hearing impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
MacKay Memorial Hospital, Tamsui Branch
New Taipei City
Shu Fen Shen, Ph.D, +886-2-2636-0300 ext. 1312, shufen@mmu.edu.tw
About this study
Official title: Effects of Virtual Reality Intervention on Anxiety and Uncertainty Before General Anesthesia Among Patients Undergoing Laparoscopic Cholecystectomy
In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience. Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care. Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features. It has been widely applied in fields such as education, psychotherapy, and healthcare education. By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia. This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety. The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia. This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group. Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery. The video introduced the operating room environment and anesthesia procedures. The control group received only the printed educational materials. Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale [APAIS], Anxiety Visual Analogue Scale [VAS]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators. Assessments were conducted before and after the intervention to evaluate its effectiveness. This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability. The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education. Furthermore, the results can serve as a reference for developing diversified patient education models in the future.
- Being tested
- Virtual Reality Intervention
- Keywords
- Virtual Reality (VR), Preoperative Anxiety, General Anesthesia, Patient Education, Physiological Feedback
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality InterventionBehavioural
Participants receive a single session of virtual reality-based preoperative education before undergoing laparoscopic cholecystectomy under general anesthesia. The virtual reality program presents information about the surgical procedure, operating room environment, anesthesia induction and recovery process through immersive audiovisual content. The intervention is designed to improve patient understanding and reduce preoperative anxiety and uncertainty.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Education Group | Experimental | Participants receive a virtual reality-based preoperative educational intervention before general anesthesia. Receives: Behavioral: Virtual Reality Intervention |
| Standard Preoperative Education Group | No intervention | Participants receive standard printed preoperative education materials before general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
APAIS will be used to measure preoperative anxiety. Total anxiety scores range from 4 to 20, where higher scores indicate a higher level of preoperative anxiety.
Measured: Baseline (before intervention) and Immediately after intervention
Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)
VAS is a self-reported scale consisting of a horizontal line. Scores range from 0 (no anxiety) to 10 (extreme anxiety), where higher scores indicate a higher level of anxiety.
Measured: Immediately after intervention and before anesthesia induction
Secondary outcomes (6)
Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
The Uncertainty Visual Analogue Scale (VAS) is a self-reported tool used to measure the intensity of preoperative uncertainty. Scores range from 0 (no uncertainty) to 100 (extreme uncertainty), where higher scores indicate a higher level of preoperative uncertainty.
Measured: Baseline (before intervention) and Immediately after intervention
Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)
IUS-12 will be used to assess the participant's emotional, cognitive, and behavioral reactions to ambiguous situations. The IUS-12 consists of 12 items with a total score ranging from 12 to 60), where higher scores indicate a lower tolerance for uncertainty (a worse outcome).
Measured: Baseline (before intervention) and Immediately after intervention
Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System
The ProComp Infiniti System (Thought Technology Ltd., distributed by Bio-Medical Instruments) will be used to measure the activation level of low-frequency electroencephalogram (EEG) waves. An increase in the measured value indicates a higher level of activation of low-frequency brainwaves, which represents an increase in the participant's stress and anxiety levels (a worse outcome).
Measured: Baseline (before intervention) and Immediately after intervention
Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System
The ProComp Infiniti System will be used to measure heart rate variability (HRV) indicators. Higher HRV values generally represent better autonomic nervous system flexibility and superior stress regulation (a better outcome). Conversely, lower HRV values are associated with higher levels of stress and anxiety.
Measured: Baseline (before intervention) and Immediately after intervention
Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale
The Chinese version of the Technology Acceptance Model (TAM) scale will be used to evaluate the participants' acceptance of virtual reality technology. The total score ranges from 11 to 33, with higher scores indicating a higher level of patient acceptance toward virtual reality technology. This assessment includes dimensions such as behavioral intention to use, perceived usefulness (believing it is helpful), and perceived ease of use (finding operations simple and convenient).
Measured: Baseline (before intervention) and Immediately after intervention
Participant Satisfaction Assessed by the Patient Satisfaction Scale
Patient Satisfaction Scale will be used to assess the participants' level of satisfaction with the intervention. The total score ranges from 10 to 50, where a higher score indicates a higher level of satisfaction with the program
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start9 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656246
- Sponsor's protocol ID
- 25MMHIS300e
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Intervention on Anxiety and Uncertainty Before General Anesthesia Among Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07656246
- Acronym / sponsor ID
- 25MMHIS300e
- Keywords
- Virtual Reality (VR), Preoperative Anxiety, General Anesthesia, Patient Education, Physiological Feedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Mackay Medical College
- Study start
- 9 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience. Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care. Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features. It has been widely applied in fields such as education, psychotherapy, and healthcare education. By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia. This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety. The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia. This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group. Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery. The video introduced the operating room environment and anesthesia procedures. The control group received only the printed educational materials. Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale [APAIS], Anxiety Visual Analogue Scale [VAS]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators. Assessments were conducted before and after the intervention to evaluate its effectiveness. This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability. The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education. Furthermore, the results can serve as a reference for developing diversified patient education models in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Education Group | Experimental | Behavioral: Virtual Reality InterventionParticipants receive a virtual reality-based preoperative educational intervention before general anesthesia. |
| Standard Preoperative Education Group | No intervention | –Participants receive standard printed preoperative education materials before general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- Able to communicate in Mandarin Chinese or Taiwanese and complete questionnaires.
- ASA Physical Status I-II.
- Hospitalized one day before surgery.
- No previous experience with general anesthesia.
Key exclusion criteria (3 listed)
- Psychiatric disorders.
- Emergency surgery.
- Visual or hearing impairment.
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 |
|---|---|---|
| Virtual Reality InterventionParticipants receive a single session of virtual reality-based preoperative education before undergoing laparoscopic cholecystectomy under general anesthesia. The virtual reality program presents information about the surgical procedure, operating room environment, anesthesia induction and recovery process through immersive audiovisual content. The intervention is designed to improve patient understanding and reduce preoperative anxiety and uncertainty. | Behavioural | Virtual Reality Education Group |
Primary outcome
Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Baseline (before intervention) and Immediately after intervention
APAIS will be used to measure preoperative anxiety. Total anxiety scores range from 4 to 20, where higher scores indicate a higher level of preoperative anxiety.
Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)
Time frame: Immediately after intervention and before anesthesia induction
VAS is a self-reported scale consisting of a horizontal line. Scores range from 0 (no anxiety) to 10 (extreme anxiety), where higher scores indicate a higher level of anxiety.
6 secondary outcomes
Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Time frame: Baseline (before intervention) and Immediately after intervention
Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)
Time frame: Baseline (before intervention) and Immediately after intervention
Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System
Time frame: Baseline (before intervention) and Immediately after intervention
Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System
Time frame: Baseline (before intervention) and Immediately after intervention
Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale
Time frame: Baseline (before intervention) and Immediately after intervention
Participant Satisfaction Assessed by the Patient Satisfaction Scale
Time frame: Immediately after intervention
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 2 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Intervention in people with Cholecystectomy, Laparoscopic and Anxiety, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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 Taiwan. 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?
Contact Shu Fen Shen, Ph.D (+886-2-2636-0300 ext. 1312, shufen@mmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS) (time frame: Baseline (before intervention) and Immediately after intervention). 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 2 Jul 2026.