Impact of 3D-Printed Anatomical Models on Patient Understanding, Anxiety, Patient-Doctor Relationship, and Overall Satisfaction During the Informed Consent Process in Orthognathic Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient understanding
研究概览
简要总结
The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery. The trial also explores how these models affect participants understanding, anxiety, satisfaction, and communication with the surgeon.
The main questions it aims to answer are:
- Do 3D-printed anatomical models improve participants understanding of their jaw condition and the surgical procedure?
- Do they reduce participants anxiety before surgery?
- Do they enhance overall participants satisfaction and the physician-patient relationship?
Researchers compares participants who received standard two dimensional (2D) imaging and verbal explanations with those who received the same information plus 3D-printed jaw models.
Participants:
- Scheduled for double- or triple-jaw orthognathic surgery
- Randomly assigned to receive either traditional 2D education or the 3D-printed model intervention
- Complete a validated questionnaires assessing understanding, anxiety, satisfaction, and doctor-patient communication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 and above)
- •Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)
排除标准
- •Pediatric patients (under 18 years old)
- •Patients undergoing re-do/revision surgery
- •Patients with psychiatric disorders
- •Patients receiving only orthodontic treatment
- •Patients undergoing single-jaw surgery
研究组 & 干预措施
2D Surgical Simulation
This group received an orthognathic surgery consultation incorporating two-dimensional images generated from virtual surgical planning. These images illustrated the patient's current skeletal deformity and the anticipated surgical movements, providing a visual aid to enhance understanding and facilitate informed decision-making.
干预措施: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery (Combination Product)
3D Surgical Simulation
This group received an orthognathic surgery consultation using 3D-printed anatomical models. The models, representing skeletal Class II and Class III deformities, were customized and modified to simulate osteotomies. During the consultation, these models are used to demonstrate the planned surgical movements, providing patients with a tangible, visual understanding of their condition and the proposed treatment.
干预措施: 3D-printed Orthognathic Surgical Simulation (Combination Product)
结局指标
主要结局
Patient understanding
时间窗: Baseline
Patient comprehension scores of their jaw condition, planned surgical procedures (Le Fort I, bilateral sagittal split osteotomy, and genioplasty), potential complications, expected outcomes, and the overall consent process, measured by a structured questionnaire at the time of consent.
次要结局
- Anxiety level(Baseline)
- Patient-doctor relationship(Baseline)
- Patient Satisfaction(Baseline)
研究者
Razan Baabdullah
Assistant professor of oral and maxillofacial surgery Affiliation: King Abdulaziz University
King Abdulaziz University