Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:08 AM
Study NCT ID:
NCT07483866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients
Sponsor:
Jia-Ling Wang
Organization:
Study Overview
Official Title:
The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR
Brief 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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 114190-E | OTHER_GRANT | FarEasternMH | View |