Preoperative AnxietyVRNCT07483866
The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients
A study testing Virtual reality and Conventional Video in people with Preoperative Anxiety, run by Jia-Ling Wang.
Trial summary
Study Design and Participants This study employed a prospective, randomized controlled trial (RCT) design. A total of two study arms were established: an experimental group receiving a virtual reality (VR) education intervention combined with conventional care, and a control group receiving a unit health education… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Virtual reality and Conventional Video
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2026to 31 Dec 2027
- 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
- Must be 18 years of age or older.
- Must be scheduled for orthopedic surgery and be scheduled to undergo spinal anesthesia.
- Must have no anxiety disorders, no visual or auditory impairments, be fully conscious, and be able to understand and read Chinese.
- Must be classified as a Class I to III by the American College of Anesthesiologists.
Who cannot join
- Previous head injury.
- History of dizziness.
- Patient requiring transfer to the intensive care unit due to their condition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Study Design and Participants This study employed a prospective, randomized controlled trial (RCT) design. A total of two study arms were established: an experimental group receiving a virtual reality (VR) education intervention combined with conventional care, and a control group receiving a unit health education film with conventional care.
Participants were recruited based on the following inclusion criteria: adults aged 18 years or older scheduled for elective hip or knee replacement surgery under spinal anesthesia; an American Society of Anesthesiologists (ASA) physical status grade of I to III; clear consciousness with the ability to read and understand Chinese; and no prior diagnosis of anxiety disorders or significant visual/hearing impairments. Patients were excluded if they had a history of head trauma or chronic dizziness, or if they required post-operative transfer to the intensive care unit (ICU) due to medical complications.
Read more
Randomization and Intervention Eligible participants were assigned to either the experimental or control group using block randomization to ensure balanced group sizes. The primary intervention for the experimental group consisted of a structured Virtual Reality Education Program, while the control group received standard institutional health education via video.
Data Collection and Instrumentation A repeated-measures approach was utilized for data collection across four distinct time points: (1) baseline (one day prior to surgery), (2) pre-operative arrival at the operating room holding area on the day of surgery, (3) one day post-operatively, and (4) three days post-operatively.
The research instruments used for assessment included:
A demographic profile sheet. The State-Trait Anxiety Inventory (STAI). The Visual Analogue Scale for Anxiety (VAS-A). The Visual Analogue Scale for Pain (VAS-P). A Virtual Reality Education Satisfaction Questionnaire. Standardized physiological indicators.
Read the detailed description
This study adopted a randomized controlled trial design. The inclusion criteria for the study subjects were adults aged 18 years or older who were undergoing scheduled hip and knee replacement surgery and were scheduled to undergo spinal anesthesia, had no anxiety disorders, no visual or hearing impairments, were conscious, could understand and read Chinese, and had a general health status of the American Society of Anesthesiologists grade I to III; the exclusion criteria were those who had head trauma, had a history of dizziness, and had to be transferred to the intensive care unit due to illness. The cases were assigned to the experimental group (virtual reality education and conventional care) and the control group (conventional care and unit health education film) by block randomization. The intervention measure was a virtual reality education intervention program. The data collection method was a total of four repeated measurements including: baseline value (one day before surgery), from the day of surgery to the front desk of the operating room, one day after surgery, and three days after surgery. The research tools included basic information, situation-trait anxiety scale, anxiety visual scale, pain visual scale, Virtual Reality Education Satisfaction Questionnaire and physiological indicators for data collection.
- Conditions
- Preoperative Anxiety
- Being tested
- Virtual reality, Conventional Video
- Keywords
- Preoperative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
Also called VR Education
Intervention Name: Virtual Reality-Based Preoperative Education
Intervention Description:
A 10-15 minute immersive virtual reality (VR) education program administered via a head-mounted display (HMD) one day prior to surgery. The simulation provides a 360-degree interactive walkthrough of the operating room environment and the spinal anesthesia procedure (including patient positioning and sensory expectations). This intervention aims to reduce preoperative anxiety through high-fidelity sensory immersion. It is provided in addition to standard conventional nursing care.
Conventional VideoBehavioural
Intervention Name: Conventional Health Education Video
Intervention Description:
A 10-15 minute standard health education video delivered via a tablet or television screen one day prior to surgery. The video content is identical to the experimental group, covering the surgical environment, spinal anesthesia steps, and post-operative recovery exercises, but presented in a traditional 2D, non-immersive format. This group represents the current standard of care for preoperative education at the clinical site.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this arm will receive a 10-15 minute immersive virtual reality (VR) education program one day prior to surgery. Utilizing a head-mounted display (HMD), patients will experience a 360-degree simulated walkthrough of the operating room environment, the spinal anesthesia procedure (including positioning and sensations), and post-operative recovery exercises. The program is designed to reduce preoperative anxiety through sensory immersion and procedural familiarity. This intervention is provided in addition to standard institutional nursing care. Receives: Behavioral: Virtual reality |
| Control Group | Active comparator | Participants in this arm will receive standard health education via a 2D video program one day prior to surgery. The video, lasting approximately 10-15 minutes, is delivered through a tablet or television screen. The educational content is identical to the experimental group, including a walkthrough of the operating room environment, spinal anesthesia procedures, and post-operative recovery exercises. This represents the current standard of care for preoperative instruction. All participants also receive standard institutional nursing care. Receives: Behavioral: Conventional Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S)
The State-Trait Anxiety Inventory (STAI-S) is a 20-item self-report scale used to measure the participant's current state of anxiety. Each item is scored on a 4-point Likert scale (1 to 4). The total score ranges from 20 to 80, where a higher score indicates a higher level of situational anxiety.
Measured: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Secondary outcomes (2)
Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)
Participants rate their pain on a 100 mm line (0 = no pain, 100 = worst possible pain). Higher scores reflect higher pain intensity.
Measured: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Change From Baseline in Mean Heart Rate (Beats Per Minute)
Heart rate will be measured via a pulse oximeter to assess physiological stress response.
Measured: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start22 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional group (experimental group): Received VR-based intervention as the main treatment, while also receiving routine care. Control group: Received standard care and alternative interventions, such as written and verbal interventions, as the baseline for comparison.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia-Ling Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia-Ling Wang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483866
- Sponsor's protocol ID
- 114190-E
- Other IDs
- 114190-E
- Acronym
- VR
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: a plan isn't set
Publications
Liu X, Wang H, Zhao Q, Wang R, Cao H. The effectiveness of virtual reality in relieving anxiety and pain for adult oral surgical procedures patients: a systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Apr;141(4):450-464. doi: 10.1016/j.oooo.2025.10.002. Epub 2025 Oct 16.
PubMed 41407647
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients
- ClinicalTrials.gov ID
- NCT07483866
- Acronym / sponsor ID
- VR / 114190-E
- Conditions
- Preoperative Anxiety
- Keywords
- Preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jia-Ling WangUniversity, hospital or other
- Study start
- 22 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 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.
Study Design and Participants This study employed a prospective, randomized controlled trial (RCT) design. A total of two study arms were established: an experimental group receiving a virtual reality (VR) education intervention combined with conventional care, and a control group receiving a unit health education film with conventional care.
Participants were recruited based on the following inclusion criteria: adults aged 18 years or older scheduled for elective hip or knee replacement surgery under spinal anesthesia; an American Society of Anesthesiologists (ASA) physical status grade of I to III; clear consciousness with the ability to read and understand Chinese; and no prior diagnosis of anxiety disorders or significant visual/hearing impairments. Patients were excluded if they had a history of head trauma or chronic dizziness, or if they required post-operative transfer to the intensive care unit (ICU) due to medical complications.
Randomization and Intervention Eligible participants were assigned to either the experimental or control group using block randomization to ensure balanced group sizes. The primary intervention for the experimental group consisted of a structured Virtual Reality Education Program, while the control group received standard institutional health education via video.
Data Collection and Instrumentation A repeated-measures approach was utilized for data collection across four distinct time points: (1) baseline (one day prior to surgery), (2) pre-operative arrival at the operating room holding area on the day of surgery, (3) one day post-operatively, and (4) three days post-operatively.
The research instruments used for assessment included:
A demographic profile sheet. The State-Trait Anxiety Inventory (STAI). The Visual Analogue Scale for Anxiety (VAS-A). The Visual Analogue Scale for Pain (VAS-P). A Virtual Reality Education Satisfaction Questionnaire. Standardized physiological indicators.
Detailed description
This study adopted a randomized controlled trial design. The inclusion criteria for the study subjects were adults aged 18 years or older who were undergoing scheduled hip and knee replacement surgery and were scheduled to undergo spinal anesthesia, had no anxiety disorders, no visual or hearing impairments, were conscious, could understand and read Chinese, and had a general health status of the American Society of Anesthesiologists grade I to III; the exclusion criteria were those who had head trauma, had a history of dizziness, and had to be transferred to the intensive care unit due to illness. The cases were assigned to the experimental group (virtual reality education and conventional care) and the control group (conventional care and unit health education film) by block randomization. The intervention measure was a virtual reality education intervention program. The data collection method was a total of four repeated measurements including: baseline value (one day before surgery), from the day of surgery to the front desk of the operating room, one day after surgery, and three days after surgery. The research tools included basic information, situation-trait anxiety scale, anxiety visual scale, pain visual scale, Virtual Reality Education Satisfaction Questionnaire and physiological indicators for data collection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional group (experimental group): Received VR-based intervention as the main treatment, while also receiving routine care. Control group: Received standard care and alternative interventions, such as written and verbal interventions, as the baseline for comparison.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Virtual realityParticipants in this arm will receive a 10-15 minute immersive virtual reality (VR) education program one day prior to surgery. Utilizing a head-mounted display (HMD), patients will experience a 360-degree simulated walkthrough of the operating room environment, the spinal anesthesia procedure (including positioning and sensations), and post-operative recovery exercises. The program is designed to reduce preoperative anxiety through sensory immersion and procedural familiarity. This intervention is provided in addition to standard institutional nursing care. |
| Control Group | Active comparator | Behavioral: Conventional VideoParticipants in this arm will receive standard health education via a 2D video program one day prior to surgery. The video, lasting approximately 10-15 minutes, is delivered through a tablet or television screen. The educational content is identical to the experimental group, including a walkthrough of the operating room environment, spinal anesthesia procedures, and post-operative recovery exercises. This represents the current standard of care for preoperative instruction. All participants also receive standard institutional nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18 years of age or older.
- Must be scheduled for orthopedic surgery and be scheduled to undergo spinal anesthesia.
- Must have no anxiety disorders, no visual or auditory impairments, be fully conscious, and be able to understand and read Chinese.
- Must be classified as a Class I to III by the American College of Anesthesiologists.
Key exclusion criteria (3 listed)
- Previous head injury.
- History of dizziness.
- Patient requiring transfer to the intensive care unit due to their condition.
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 realityAlso: VR EducationIntervention Name: Virtual Reality-Based Preoperative Education Intervention Description: A 10-15 minute immersive virtual reality (VR) education program administered via a head-mounted display (HMD) one day prior to surgery. The simulation provides a 360-degree interactive walkthrough of the operating room environment and the spinal anesthesia procedure (including patient positioning and sensory expectations). This intervention aims to reduce preoperative anxiety through high-fidelity sensory immersion. It is provided in addition to standard conventional nursing care. | Behavioural | Experimental Group |
| Conventional VideoIntervention Name: Conventional Health Education Video Intervention Description: A 10-15 minute standard health education video delivered via a tablet or television screen one day prior to surgery. The video content is identical to the experimental group, covering the surgical environment, spinal anesthesia steps, and post-operative recovery exercises, but presented in a traditional 2D, non-immersive format. This group represents the current standard of care for preoperative education at the clinical site. | Behavioural | Control Group |
Primary outcome
Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S)
Time frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
The State-Trait Anxiety Inventory (STAI-S) is a 20-item self-report scale used to measure the participant's current state of anxiety. Each item is scored on a 4-point Likert scale (1 to 4). The total score ranges from 20 to 80, where a higher score indicates a higher level of situational anxiety.
2 secondary outcomes
Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)
Time frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Change From Baseline in Mean Heart Rate (Beats Per Minute)
Time frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
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 1 Sep 2026.
- Results publication: PubMed 41407647Liu X, Wang H, Zhao Q, Wang R, Cao H. The effectiveness of virtual reality in relieving anxiety and pain for adult oral surgical procedures patients: a systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Apr;141(4):450-464. doi: 10.1016/j.oooo.2025.10.002. Epub 2025 Oct 16.
- The objective of this systematic review and meta-analysis was to assess the effectiveness of virtual reality interventions in alleviating intraoperative pain and anxiety among adult patients undergoing oral surgical procedures.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. a plan isn't set
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Conventional Video in people with Preoperative Anxiety, run by Jia-Ling Wang.
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 4 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jia Ling WANG (886+0938562061, g462112026@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S) (time frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07483866, which also lists 1 linked publication.
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 1 Sep 2026.