The Effect of Augmented Reality in Patient Pre-operative Education
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Degree of knowledge acquisition questionnaire 2 weeks post-operative
研究概览
简要总结
The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in adults undergoing spinal surgery. The main aims of this study are:
Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.
Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.
This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices.
详细描述
This study will be performed on patients scheduled to undergo elective spinal surgery. The study will be a non-blinded, randomized clinical trial with a treatment arm and a control arm. After patient screening to determine eligibility and after patients are informed about the study and potential risks, all patients giving written informed consent will be randomized in a non-blinded manner in a 1:1 ratio to traditional preoperative patient counseling (control arm) or AR enhanced preoperative patient counseling (treatment arm). In the traditional preoperative patient counseling group, surgeons will explain the patients pathology and the surgery with only words and with or without pictures (MRI, CT, etc) and/or a generic 3D model. In the AR enhanced preoperative patient counseling group, the surgeon will have virtual, interactive models of the patients own anatomy projected through AR to show patients while describing the problem and how the surgery will be performed.
For all patients included within the treatment arm, the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection. When using Surgical AR, patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System (PACS) on the Medivis workstation. During preoperative consultation, the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset. For AnatomyX, a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient, patient family, and surgeon can exist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years-of-age
- •Undergoing elective anterior cervical discectomy and fusion (ACDF)
排除标准
- •Prior surgery
- •Vestibular dysfunction
- •Cannot tolerate AR immersion secondary to physical or psychiatric impairments
- •Cognitive impairment
- •Emergency procedures
结局指标
主要结局
Degree of knowledge acquisition questionnaire 2 weeks post-operative
时间窗: Knowledge acquisition will be completed approximately 2 weeks post-operatively
Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling
时间窗: The APAIS is to be completed within 24 hours after preoperative counseling
The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety.
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey
时间窗: The APAIS is to be completed preoperatively on the day of the surgery
The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety.
Degree of knowledge acquisition questionnaire 6 months post-operative
时间窗: Knowledge acquisition will be completed approximately 6 months post-operatively
Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Participant age
时间窗: This will be documented within 24 hours after enrollment
The patients age at the time of the intervention will be recorded
Simulator Sickness Questionnaire (SSQ)
时间窗: The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient preoperative counseling
The SSQ is used to quantify simulator sickness within individuals during or following the use of extended reality environments across 3 domains. The total score ranges from 0-235.62 with higher scores representing higher sickness.
Evaluation of the Experience of General Anesthesia (EVAN-G) Survey
时间窗: The EVAN-G will be completed within 24 hours after surgery
The EVAN-G is a patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
Participant's indication for surgery
时间窗: This will be completed within 24 hours after enrollment
The patients primary diagnosis that is the reason for surgery will be recorded
Participant's past surgeries
时间窗: This will be completed within 24 hours after enrollment
A list of the surgeries the patient has had in the past will be recorded
Doses of pain medications
时间窗: This will be completed within 24 hours after enrollment
The dose of each pain medication a patient is taking at the time of the intervention will be recorded
Prior experience with simulated environments
时间窗: This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm
This will be assessed using a Likert 1-5 scale with 1 being no experience with extended reality environments and 5 being very experienced with extended reality environments
Patient understanding of surgery 2 weeks post-operative
时间窗: Patient understanding will be assessed approximately 2 weeks post-operatively
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient understanding of surgery 6 months post-operative
时间窗: Patient understanding will be assessed approximately 6 months post-operatively
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Time of preoperative patient counseling
时间窗: Assessed during preoperative patient counseling session
The total time it takes for a surgeon to perform preoperative patient counseling will be recorded.
Degree of knowledge acquisition questionnaire preoperatively
时间窗: Knowledge acquisition will be completed preoperatively on the the day of surgery
Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Degree of knowledge acquisition questionnaire 3 months post-operative
时间窗: Knowledge acquisition will be completed approximately 3 months post-operatively
Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Participant gender
时间窗: This will be completed within 24 hours after enrollment
The patients gender will be recorded
Patient understanding of surgery at baseline
时间窗: Patient understanding will be assessed within 24 hours after preoperative counseling
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient understanding of surgery 3 months post-operative
时间窗: Patient understanding will be assessed approximately 3 months post-operatively
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient pain level 3 months post-operatively
时间窗: Pain level will be assessed approximately 3 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Patient satisfaction level with the surgical explanation at baseline
时间窗: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 2 weeks post-operatively
时间窗: Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 3 months post-operatively
时间窗: Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient surgery satisfaction level 2 weeks post-operatively
时间窗: Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient surgery satisfaction level 6 months post-operatively
时间窗: Patient surgery satisfaction will be assessed approximately 6 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Degree of knowledge acquisition questionnaire at baseline
时间窗: Knowledge acquisition will be completed within 24 hours after preoperative counseling
Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Confidence in surgeon preoperatively
时间窗: Confidence in surgeon will be assessed preoperatively on the the day of surgery
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Confidence in surgeon 2 weeks post-operatively
时间窗: Confidence in surgeon will be assessed approximately 2 weeks post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient surgery visit satisfaction level 3 months post-operatively
时间窗: Patient surgery satisfaction will be assessed approximately 3 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient pain level expectation preoperatively
时间窗: Pain level expectation will be assessed preoperatively on the the day of surgery
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon at baseline
时间窗: Confidence in surgeon will be assessed within 24 hours after preoperative counseling
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Participant education
时间窗: This will be completed within 24 hours after enrollment
The patients number of years of formal education will be recorded
Names of pain medications
时间窗: This will be completed within 24 hours after enrollment
The name of each pain medication a patient is taking at the time of the intervention will be recorded
Patient pain level 2 weeks post-operatively
时间窗: Pain level will be assessed approximately 2 weeks post-operatively
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon 6 months post-operatively
时间窗: Confidence in surgeon will be assessed approximately 6 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient visit satisfaction level preoperatively
时间窗: Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient satisfaction level with the surgical explanation preoperatively
时间窗: Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 6 months post-operatively
时间窗: Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient understanding of surgery preoperatively
时间窗: Patient understanding will be assessed preoperatively on the the day of surgery
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient pain level expectation at baseline
时间窗: Pain level expectation will be assessed within 24 hours after preoperative counseling
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Patient pain level 6 months post-operatively
时间窗: Pain level will be assessed around 6 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon 3 months post-operatively
时间窗: Confidence in surgeon will be assessed approximately 3 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient visit satisfaction level at baseline
时间窗: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
次要结局
- Patient retention rates(Patient retention rates will be assessed up to 6 months post-operatively)
- Patient preference on the type of preoperative counseling received for the AR-specific participants(This will be assessed immediately following preoperatiive counseling within the treatment group)
- Patient referral rates(Patient referral rates will be assessed up to 6 months post-operatively)
研究者
Edward Andrews
Assistant Professor
University of Pittsburgh