A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening

NANot yet recruitingINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

June 30, 2024

Study Completion Date

July 30, 2024

Conditions
Cervical Cancer
Interventions
DEVICE

Novel Smart Speculum

"The examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or no pain, to a crying face at 10, which represents worst pain possible. Her response will be recorded immediately.~Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately."

DEVICE

Standard speculum

"he examiner will lubricate the intended speculum with a water-based lubricant then insert through the vagina. Immediately after the first speculum is inserted, and before the examiner attempts to expand the blades to visualize the cervix, the participant's comfort will be assessed using a modified version of the 0-10 Universal Pain Assessment Tool, which shows a series of faces ranging from happy face at 0, or no pain, to a crying face at 10, which represents worst pain possible. Her response will be recorded immediately.~Then the examiner will open the speculum adequately to visualise the cervix. At this point, the visual analogue scale will be given to the participant and told to indicate again the level of pain following manipulation of the speculum, using a scale of 0 (no pain) to 10 (the worst pain imaginable). Her response will be recorded immediately."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GICMED

OTHER

NCT06359431 - A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening | Biotech Hunter | Biotech Hunter