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Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.
Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.
Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | The virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation. |
|
| Control | No Intervention | Patients undergo traditional colonoscopy procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonpharmacological method | Other | Virtual reality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Visual Analogue Scale Mean Scores by Groups | Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome. | Evaluated immediately after colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of State Trait Anxiety Inventory Mean Scores by Groups | State Trait Anxiety Inventory evaluates anxiety with a scale containing 20 items, scoring between 20 points (no anxiety) to 80 points (high anxiety). | Evaluated immediately both prior and after colonoscopy. |
| Comparison of Vital Signs between Groups: Pulse Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingyun Yang, MD | Contact | 18510031805 | +86 | yingyunyang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingyun Yang, MD | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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a single-centered, prospective, randomized controlled study
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All vital signs of patients will be measured by a same multifunctional ECG monitor. |
| Evaluated both before and every 3 minutes during colonoscopy. |
| Comparison of Vital Signs between Groups: Blood Pressure | All vital signs of patients will be measured by a same multifunctional ECG monitor. | Evaluated both before and every 3 minutes during colonoscopy. |
| Comparison of Vital Signs between Groups: Respiration Rate | All vital signs of patients will be measured by a same multifunctional ECG monitor. | Evaluated both before and every 3 minutes during colonoscopy. |
| Comparison of Vital Signs between Groups: Oxygen Saturation | All vital signs of patients will be measured by a same multifunctional ECG monitor. | Evaluated both before and every 3 minutes during colonoscopy. |
| Comparison of Patient Satisfaction of Colonoscopy between Groups | Patient satisfaction will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher satisfaction. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration. | Evaluated immediately after colonoscopy. |
| Comparison of Patient Willingness of Future Colonoscopy between Groups | Patient willingness to undergo future colonoscopies will be assessed by a self-made rating form. Results will be reported on a scale of 1-5 with a higher score standing for higher willingness. Results will be adjusted by bowel preparation, cecal intubation rate, and procedural duration. | Evaluated immediately after colonoscopy. |
| Comparison of Adverse Effects in both groups | Any adverse effect (e.g. nausea, vomiting, headache, or dizziness) would be immediately recorded. | During and immediately after colonoscopy. |