Role of Presurgical Illustration on Patients' Psychological Stress Monitored by Salivary Cortisol in Mandibular Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Salivary Cortisol Level (in ng/mL)
研究概览
简要总结
The aim of this clinical trial is to evaluate the influence of presurgical patient's diagrammatic illustration of mandibular third molar (Wisdom tooth) surgery on degrees of psychological stress.
详细描述
Psychological stress is a common factor accompanied with surgeries in most situations, and mandibular third molar (Wisdom tooth (WT)) surgery couldn't be an exception. Saliva was proven as a valid carrier that could be used to track the levels of cortisol representing the degree of patient's provoked stress. Patient orientation and presurgical diagrammatic illustration of the steps of WT surgery are very important aspects for patient preparation, yet, may be potential stress triggers as well.
This study aims to figure out if patients are exposed to illustrations that shows the mandibular third molar surgery before having the surgery would aggravate their stress or may relieve it considering orientation and relative absence of fear of unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
Both the participant and the surgeon are not blinded to the study predictor variable as they both witness the presurgical illustration (introduced to the study group). The laboratory chemist that will analyze the salivary cortisol is blinded to both arms. This means that the chemist does not know whether the saliva sample is drawn from a patient in the control or the study groups.
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients (American Society of Anesthesiologists Class I),
- •Patients demanding extraction of their mandibular third molar,
- •Mandibular third molars requiring flap raising, bone removal, coronal and radicular sectioning (Modified Parant Scale Class IV),
- •Patients accepting their saliva sampling prior to and after surgery.
排除标准
- •Acutely painful mandibular third molars on clinical examination,
- •Pericoronal and/or active periapical and/or active periodontal pathologies on clinical and radiographic examinations,
- •Patients using steroids,
- •Psychiatric patients,
- •Pregnant patients, and/or those observing their menstruation,
- •Patients with conditions of altered cortisol secretion (such as Addison's disease, Cushing's syndrome, and congenital adrenal hyperplasia),
- •Patients with altered secretion of saliva (such as due to using atropine, calcium channel blockers, antidepressants, antihistamines, Sjogren's syndrome, and radiotherapy).
- •Patients who are overtly anxious about dental treatment (scoring >19 on the Modified Dental Anxiety Scale).
研究组 & 干预措施
Control Group (No Presurgical Illustration)
Patients in this group will have their mandibular third molar surgery done without having prior exposure to presurgical diagrammatic illustration for their surgery.
Study Group (Presurgical Illustration)
Patients in this group will have their mandibular third molar surgery done after having prior exposure to presurgical diagrammatic illustration for their surgery.
干预措施: Presurgical Diagrammatic Illustration for Mandibular Third Molar Surgery (Other)
结局指标
主要结局
Salivary Cortisol Level (in ng/mL)
时间窗: 45 minutes before surgery, and 30 minutes after surgery.
Amount of salivary cortisol found in patients' saliva is considered directly proportional to degree of psychological stress.
次要结局
- Duration of Surgery (in minutes)(Same time of surgery)