Examination, Gynecological, Examination, Pelvic, Examination, Vaginal
Conditions
Keywords
lubricating, gel, speculum, Pain, Pelvic, Examination, Gynecological
Brief summary
The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.
Detailed description
The outcome measure is patient discomfort as measured by a visual analogue scale.
Interventions
PROCEDURELubricating 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.
PROCEDUREWater 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.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing vaginal speculum examination between the ages of 18 and 50.
Exclusion criteria
* Pregnancy. * Non-English speaking. * Using hormone therapy. * Active vulvar or vaginal lesion, infection or complaint. * Undergoing vaginal or vulvar procedure or biopsy. * History of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis. * History of prior vulvar or vaginal surgical procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale. | Immediate. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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. | 60 |
| Total | 119 |
Baseline characteristics
| Characteristic | Lubricating Gel | Water | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 60 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 54 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 59 Participants | 60 Participants | 119 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
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.
Time frame: Immediate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubricating Gel | Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale. | 1.41 score on a scale | Standard Deviation 1.55 |
| Water | Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale. | 2.15 score on a scale | Standard Deviation 1.93 |