81
Participants
Start Date
April 1, 2024
Primary Completion Date
June 30, 2024
Study Completion Date
July 30, 2024
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."
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."
Lead Sponsor
GICMED
OTHER