Effect of Video Colposcopy in reducing patient anxiety compared to conventional colposcopy - A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- To study the effect of video colposcopy on anxiety
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women attending colposcopy clinic
- •Age 25-65 years
- •First visit to colposcopy clinic.
Exclusion Criteria
- •Pregnancy
- •Diagnosed Anxiety disorder.
- •Other Gynecological malignancy.
- •Women who cannot understand Tamil.
Outcomes
Primary Outcomes
To study the effect of video colposcopy on anxiety
Time Frame: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
levels using STAI score in women undergoing
Time Frame: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
colposcopy compared to those undergoing
Time Frame: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
colposcopy without Video colposcopy.
Time Frame: Questionnaire 1:10 minutes Before the colposcopy procedure. | questionnaire 2: Immediately after the procedure.
Secondary Outcomes
- To study the effect of video colposcopy on pain(using VAS in women undergoing colposcopy)