跳至主要内容
临床试验/NCT03005795
NCT03005795已完成不适用

Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.

Zydolab - Institute of Cytology and Immune Cytochemistry4 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2017年2月1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
发起方
入组人数
205
试验地点
4
主要终点
Change in anxiety scores

研究概览

简要总结

To assess the effect of music during colposcopy on women´s anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women referred for colposcopy due to cervical abnormalities
  • We included women if they attended colposcopy for the first time

排除标准

  • pregnant women
  • presence of a language barrier
  • known anxiety disorder or depression
  • history of conization or other treatments on the cervix uteri
  • known oncological disorder
  • auditory defect
  • cardiovascular disease
  • inadequate colposcopy

研究组 & 干预措施

Music and colposcopy

Experimental

Women will hear Mozarts symphony Nr. 40 during the colposcopic examination

干预措施: Headphones (Device)

Colposcopy without music

Active Comparator

During the colposcopic examination women will not hear music

干预措施: No Headphones (Other)

结局指标

主要结局

Change in anxiety scores

时间窗: 10 minutes before and after colposcopy

Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.

次要结局

  • Change in heart rate(10 minutes)
  • general unpleasantness during examination(10 minutes)
  • Anxiety during examination(10 minutes)
  • Pain during examination(10 minutes)
  • Overall Satisfaction(10 minutes)
  • Anxiety score after colposcopy(10 minutes before and after colposcopy)
  • Pain after examination(10 minutes)

研究者

发起方
Zydolab - Institute of Cytology and Immune Cytochemistry
申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验