Effect of Video Colposcopy in reducing patient anxiety compared to conventional colposcopy - A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To study the effect of video colposcopy on anxiety
研究概览
简要总结
Cervical cancer is one of the most common
malignancies in developing countries. 1
Women experience high level of anxiety at all stages of
evaluation of cervical cancer from pap smear,
colposcopy to treatment. Colposcopy is a standard
procedure in evaluation of cervical dysplasia. Most
women are not aware of the anatomy and the procedure
is associated with additional anxiety as it is for the
diagnosis of a possible cancerous lesion. 2–4 This leads to
higher discomfort, disappointment in own body,
anxiety, doubts regarding reproduction and loss to
follow up. The level of anxiety can be greater than
those measured in women awaiting major surgery. 5 As it
is important to reduce the anxiety level in patients
referred for colposcopy, interventions which can reduce
this anxiety are useful. There are studies which have
tried interventions such as pre-procedure counselling,
music, individual information regarding the procedure,
information brochures.
Another intervention that is being tried is video
colposcopy.
Video colposcopy involves live video
demonstration of the colposcopy procedure to the
patient. The patient gets to view in real time and
understand the procedure when it is performed.Video
colposcopy enables patients to understand the anatomy
and disease condition better, hence may reduce patient anxiety
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women attending colposcopy clinic
- •Age 25-65 years
- •First visit to colposcopy clinic.
排除标准
- •Pregnancy
- •Diagnosed Anxiety disorder.
- •Other Gynecological malignancy.
- •Women who cannot understand Tamil.
结局指标
主要结局
To study the effect of video colposcopy on anxiety
时间窗: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
levels using STAI score in women undergoing
时间窗: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
colposcopy compared to those undergoing
时间窗: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
colposcopy without Video colposcopy.
时间窗: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
次要结局
- To study the effect of video colposcopy on pain(using VAS in women undergoing colposcopy)