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临床试验/NCT07062393
NCT07062393已完成不适用

Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: A Randomized Clinical Controlled Trial

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Shared decision-making score

研究概览

简要总结

This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. The study assesses patient and caregiver satisfaction, decision-making confidence, and communication quality. Health care providers' perspectives on the counseling methods are also examined. Participants will be assigned to one of the two counseling groups and asked to complete a questionnaire immediately after the counseling session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 20 years and older
  • •Scheduled for elective thoracic surgery
  • •Able to understand written and spoken Mandarin
  • •Willing and able to provide informed consent
  • •Capable of completing questionnaires independently or with minimal assistance

排除标准

  • •Emergency surgery cases
  • •Severe cognitive impairment or psychiatric illness interfering with participation
  • •Visual or hearing impairments that prevent interaction with mobile devices
  • •Previous participation in a similar counseling trial
  • •Inability to complete follow-up procedures

研究组 & 干预措施

Traditional First, Then MAR Counseling (T-M group)

Experimental

Participants receive traditional counseling first, followed by MAR counseling using a 3D mobile application.

干预措施: Traditional Counseling → MAR Counseling (Behavioral)

MAR First, Then Traditional Counseling (M-T group)

Experimental

Participants receive MAR counseling first using a mobile 3D model app, followed by traditional counseling with CT images and verbal explanations.

干预措施: MAR Counseling → Traditional Counseling (Behavioral)

结局指标

主要结局

Shared decision-making score

时间窗: Immediately after counseling session (single timepoint)

Shared decision-making was evaluated using a validated questionnaire assessing patient perceptions of decision support, preparedness, and engagement. The total score ranges from 0 to 50, with higher scores indicating better shared decision-making.

次要结局

  • Patient counseling preference(Immediately after both counseling sessions)
  • Patient counseling preference(Immediately after both counseling sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Ying-Shian

MD

Tri-Service General Hospital

研究点 (2)

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