Trial Outcomes & Findings for The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion. (NCT NCT01289665)

Last Updated: 2020-11-17

Results Overview

The outcome measure is a single measurement of pain using a 10-point visual analog scale entitled "Visual Pain Scale" immediately following speculum insertion. The scale is a continuous 10cm line with the minimum value of 0 (labeled "no pain") on the left side of the line, and a maximum value of 10 (labeled "worst pain") on the right side of the line. Higher scores represent more pain and a worse outcome. There are no additional measurements obtained, and patients will not be followed for study purposes thereafter.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Immediate.

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Lubricating Gel Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.	Water Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
Overall Study STARTED	60	60
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubricating Gel n=59 Participants Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.	Water n=60 Participants Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	54 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediate.

Outcome measures

Outcome measures
Measure	Lubricating Gel n=59 Participants Lubricating gel used during speculum insertion.: Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.	Water n=60 Participants Water used during speculum examination.: Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.	1.41 score on a scale Standard Deviation 1.55	2.15 score on a scale Standard Deviation 1.93

Adverse Events

Lubricating Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ashley Hill

AdventHealth

Phone: 407-303-1444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place