NCT01933191已完成不适用
A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in VAS - visual analog scale
研究概览
简要总结
A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.
详细描述
The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure.
Primary efficacy endpoint:
Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior to the elective minor dental procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 18 years of age or older
- •A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations
- •Scheduled appointment for an elective minor dental procedure
- •Informed consent
排除标准
- •Pregnant or lactating women
- •Current diagnosis of any other DSM-IV, with the exception of other phobic disorders, social anxiety disorder or dysthymia
- •Serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% VO2max
结局指标
主要结局
Change from Baseline in VAS - visual analog scale
时间窗: Baseline and one hour after dental intervention
Change in the visual analogue scale (VAS) for anxiety
次要结局
- Change from Baseline in cortisol level(Baseline and one hour)
- Change from Baseline in alpha-Amylase(Baseline and one hour after dental intervention)
研究者
Prof. Dr. Andreas Ströhle
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMTHematological MalignanciesNCT00163644Bayside Health66
撤回
不适用
An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer PatientsOvarian CarcinomaNCT02878980City of Hope Medical Center
已完成
不适用
The Effect of Exercise on Peripheral Blood Gene Expression in AnginaAngina PectorisNCT01147952Sheffield Teaching Hospitals NHS Foundation Trust60
已完成
不适用
The effect of exercise on the prevention of endothelial ischemia-reperfusion injurycoronary artery disease10011082NL-OMON40007niversitair Medisch Centrum Sint Radboud17
已完成
不适用
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple SclerosisExerciseNCT01065090Biogen38