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临床试验/CTRI/2021/11/038203
CTRI/2021/11/038203已完成不适用

Effect of Video Colposcopy in reducing patient anxiety compared to conventional colposcopy - A Randomized Controlled Trial.

JIPMER INTRAMURAL1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月15日最近更新:
适应症

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)

研究者

发起方
JIPMER INTRAMURAL
申办方类型
Research institution and hospital

研究点 (1)

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