Patient's Induced Stress and Young Practitioner's Induced Stress During Endodontic Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The main study criteria is the variation of stress.
研究概览
简要总结
The aim of this pilot study is to examine the patient's induced stress and the young dentist's induced stress, during endodontic treatment. This study is carried out using physiologic (cortisol measurement, arterial pressure and heart rate) and psychological data (VAS visual analog scale of stress, pain and discomfort, CORAH and HAD Scales) collected from patients of Brest University Dental Hospital at various stages of root canal treatment. The endodontic treatment is carried out under the usual standards and practices.
详细描述
Thirty patients and students are involved. All adult patients referred to the dental department for initial endodontic treatment are given the option of taking part, excluding those presenting cardiovascular disease or mental, psychiatric, or neuronal disease. Patients taking antihypertensive treatment, anxiolytics, sedatives, or neuroleptic drugs are also excluded from the study. Thirty dental students will conduct endodontic treatments according to the regular local procedures. No patient receives any sedative premedication.
The indicators of stress are monitored at 6 steps of endodontic treatment:
T1: preoperative rest; T2: local anaesthesia (4% articaïne hydrochloride with 1:200 000 epinephrine). T3: rubber-dam set-up T4: root canal instrumentation T5: root canal filling T6: postoperative rest
The main study criteria is the variation of stress:
At the 6 steps of the treatment and at the next visit for the final restoration, both subjects (patient and student) are asked to use a visual analog scale (VAS) to score the level of stress specifically induced by the endodontic treatment. The VAS is a 10-cm scale without graduation on which subjects are asked to score the specific level of stress experienced from 0 (not stressed at all) to 10 (worst stress imaginable). The VAS of stress has proven to be a valid tool that is highly sensitive to change.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 18 and 60 years old
- •Patients who need endodontic treatment
- •Patients insured under the French social security system
排除标准
- •Pregnant women
- •Participants refusing to take part
- •Patients not fluent in French.
- •Patients who have certain diseases which do not allow interpretion of the cardiovascular outcomes (cardiac rhythm disorder, hypertension)
- •Treatments or diseases which may have profound implications on stress modulation
- •Certain diseases which affect cortisol levels: Cushing, Addison, obesity (body mass index (BMI) > 30 kg/m²), schizophrenia, personality and behaviour disorders.
结局指标
主要结局
The main study criteria is the variation of stress.
时间窗: At the 6 steps of the treatment and at the next visit for the final restoration : up to 15 days
At the 6 steps of the treatment and at the next visit for the final restoration, both subjects (patient and student) are asked to use a visual analog scale (VAS) to score the level of stress specifically induced by the endodontic treatment. The VAS is a 10-cm scale without graduation on which subjects are asked to score the specific level of stress experienced from 0 (not stressed at all) to 10 (worst stress imaginable). The VAS of stress has proven to be a valid tool that is highly sensitive to change.
次要结局
- Cardiovascular Parameters(During endodontie treatment (one day) and at the next visit for the final restoration (15 days after))
- Discomfort and Pain Experienced During Treatment(During endodontic treatment (one day) and at the next visit for the final restoration (15 days after).)
- CORAH .(At the beginning of the treatment (T1) : one day)
- Cortisol Measurements(During endodontic treatment (one day).)
- HAD Scales.(At the beginning of the treatment (T1) : one day)