Hill, D. Ashley MD; Lamvu, Georgine MD, MPH
From the Departments of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, and University of Central Florida College of Medicine, Orlando, Florida.
The authors thank Yvonne Colon, ALNP, for preparing study samples.
Corresponding author: D. Ashley Hill, MD, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education and University of Central Florida College of Medicine, 235 East Princeton Street, #200, Orlando, FL 32835; e-mail: D.Ashley.Hill.MD@FLHOSP.ORG.
Financial Disclosure The authors did not report any potential conflicts of interest.
OBJECTIVE: To estimate the efficacy of lubricating gel compared with using water for pain during vaginal speculum insertion.
METHODS: This study was a randomized trial of nonpregnant women aged 18–50 years who required a vaginal speculum examination between February and July 2011. Patients blinded to study assignment underwent vaginal speculum examination using a standardized technique with a medium-sized plastic speculum prepared with either 0.3 mL lubricating gel or 3 mL of water used to cover both speculum blades. Patients recorded pain using a 10-cm visual analog scale immediately after speculum insertion. A pre hoc power analysis determined that 55 patients in each arm would be required to detect a difference of 0.9 cm on a 10-cm visual analog scale.
RESULTS: A total of 299 consecutive women requiring vaginal speculum examination were screened for enrollment and 120 women were randomized with 60 per group. There were no marked differences in the demographic characteristics of the gel (n=59) and water (n=60) participants available for final analysis. The gel group showed significantly lower pain scores for speculum insertion (mean±standard deviation: 1.41±1.55 compared with water 2.15±1.93, P<.01). Of patients undergoing examination with gel, 20 of 59 (33.9%) marked zero on the pain scale compared with six of 60 (10%) patients receiving water (P=.002). All 73 patients who underwent Pap screening had adequate cytology.
CONCLUSION: Applying a small amount of lubricating gel significantly decreases patient pain during vaginal speculum insertion.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01289665.
LEVEL OF EVIDENCE: I
Speculum examination is a common procedure for performing cervical cytology screening and evaluation of patients with conditions such as vaginitis, pelvic pain, and cervical or vaginal sexually transmitted infections. In the United States, there are approximately 55 million cervical cytology screening examinations performed annually.1 Fear of pain during the gynecologic examination is a barrier to patient compliance for cervical cytology screening.2,3 Unfortunately, the majority of women who die of cervical cancer have not had cytology screening in 5 or more years.4 Methods to reduce patient discomfort may lead to an increase in willingness to undergo speculum examination and an improvement in screening for cervical cancer and sexually transmitted infections.
There have been recent efforts to encourage the use of lubricating gel for vaginal speculum examinations.5 One barrier to using lubricating gel is the belief by some that lubricating gel interferes with cervical cytology and sexually transmitted infection screening results.5 However, there is convincing evidence from clinical trials that using gel does not increase either unsatisfactory Pap testing rates6,7 or differences in detection rates of Chlamydia trachomatis.7 Despite this information, many clinicians still use water, rather than gel, as a lubricant for vaginal speculum insertion. The objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water.
MATERIALS AND METHODS
This study was conducted at the faculty practice of the Florida Hospital Obstetrics and Gynecology Department from February through July 2011. The Florida Hospital institutional review board approved the study protocol, which was designed as a randomized, single-blind trial conducted according to Consolidated Standards of Reporting Trials guidelines.8 Consecutive patients aged 18–50 years who presented with conditions requiring vaginal speculum examination were screened for participation. All participants were informed of the risks and benefits of the study and written informed consent was obtained by the lead investigator. All participants volunteered participation and no incentives were offered. After consent, demographic data were collected as shown in Table 1.
To prevent inclusion of participants who had conditions that may alter pain perception with speculum insertion, the screening process excluded women who were menopausal (as determined by an elevated follicle-stimulating hormone level, use of hormone therapy, or amenorrhea for 12 months or more); were pregnant or within 6 weeks of delivery; had dyspareunia, vaginitis, vulvar pain, or vulvar lesions; or were undergoing a vulvar, vaginal, or uterine procedure. Additionally, patients not fluent in English and those who had never had vaginal intercourse were excluded from the study.
After enrollment, participants were assigned to either the lubricating gel or water arms using a permuted-block, computer-generated schedule using blocks of four. Randomization results were sealed in opaque envelopes in sequential order unknown to the investigator or study participants.
A single examiner (D.A.H.) performed a speculum examination for all participants using a standardized protocol that was identical for each participant to decrease interobserver variability. The investigator used a medium-sized plastic Graves (bivalved) speculum, which measures 3 cm across the tip and has a halogen light inserted into the base. Patients were placed in the dorsal lithotomy position with buttocks 3 cm past the edge of the examination table and feet in stirrups. Gel and water samples were previously loaded into identical sterile 3-mL syringes kept at room temperature. For participants randomized to gel, an assistant placed 0.3 mL sterile lubricating gel on the distal tip of the speculum. We chose this amount because it covers a 1-cm diameter circle embossed into the distal end of the top blade of the speculum by the manufacturer, which is a convenient method for clinicians to standardize the amount of lubricant used. Furthermore, smearing this amount of gel will cover the top and bottom speculum blades with a thin coating of lubricant. This product contains hypromellose, propylene oxide, propylene glycol, and water and does not contain “carbomers” or “carbopol polymers,” which can adversely affect liquid-based cytology.9
For patients randomized to water, the speculum's top and bottom blades were moistened with 3 mL of tap water previously loaded into a syringe kept at room temperature. The investigator inserted the speculum the same way for every participant. To prevent participants from determining which study arm they were allocated to, the investigator prepared every speculum using the preloaded syringe below a privacy drape. For both the gel and water techniques, the participant was instructed to make a single, vertical mark on a 10-cm, nonhatched visual analog scale immediately after the speculum was opened to the third notch to indicate her level of pain during insertion. Participants were told that 0 represents “no pain” and 10 “the worst pain imaginable.”10 No attempt to visualize the cervix was undertaken before asking the patient to mark the visual analog scale. After pausing to allow the patient to mark her score, any additional procedures such as cervical cytology screening or collection of samples for vaginitis were performed, but the patient did not record her pain level for any of these additional procedures.
We used the visual analog scale because this is a validated, reliable instrument for assessing pain.10–12 Results from a smaller study of speculum insertion showed mean pain levels±standard deviation during “dry” speculum insertion (no water or lubricant) of 1.7±1.3 cm on a 10-cm visual analog scale.13 An unpublished pilot study at the investigators' practice of 40 patients found a mean pain score±standard deviation of 1.9±1.6 for speculum insertion using water on the 10-cm visual analog scale. Using data from the pilot study and assuming that a reduction in pain of 0.9 cm on the visual analog scale is clinically significant between the water and gel groups based on previous research,11,12 the study would need 55 patients in each arm assuming an α of .05 and a power of 90% and a 1:1 allocation ratio using a one-sided test. Assuming that approximately 10% of patients would be excluded as a result of unforeseen vulvar or vaginal conditions after randomization, 60 participants were recruited for each arm.
All statistical analyses were performed using STATA 10.0 software. Variables first were inspected for accuracy and missing data. Univariable comparisons of demographic characteristics and potential differences between the gel and water groups were analyzed using t tests for continuous variables that did not violate the normal distribution assumption and Pearson's χ2 test for categorical variables. All reported P values are two-sided and statistical significance was set at P<.05. The outcomes for each participant were analyzed in the group to which they were assigned, regardless of whether or not that participant completed the study.
A total of 299 women presented for indicated vaginal speculum examinations during the study period; 120 women were randomized (60 to each arm of the trial) with a total of 59 women in the gel arm and 60 women in the water arm available for final analysis (Fig. 1). There were no marked differences in demographic data between the two groups (Table 1). The study design excluded conditions that would alter pain perception, so the most common indication was a routine annual gynecologic examination (92.4% of all participants). Other indications for participation included intrauterine device assessment, follow-up Pap testing, and obtaining cervical cultures.
As shown in Table 2, statistically significant lower total mean pain scores were identified in the gel group (1.41) compared with the water group (2.15; P<.011). A total of 33.9% of gel participants and 10% of water participants reported a zero score on the visual analog scale (P=.002).
Although this study was not designed nor powered to determine whether gel or water use alters the rate of satisfactory Pap test results, we noted that none of the 35 patients in the gel arm or the 38 patients in the water arm who underwent screening using liquid cytology had unsatisfactory results.
Our results indicate that using lubricating gel for vaginal speculum insertion significantly decreases pain compared with using water. Placing gel between the plastic blades of the speculum and the vaginal walls decreases friction, which we theorized would lead to less pain compared with using water alone as a lubricant. Despite the frequency of vaginal speculum examinations, there is limited information to assist clinicians with how to perform the gentlest examination. Previous research has focused on various methods to improve patient comfort or decrease anxiety during gynecologic examinations, including patient position,14,15 different types of specula,16 types of examination gowns,17 and assessing patient satisfaction with speculum self-insertion.18 This is the only study we are aware of comparing gel with water for pain during vaginal speculum insertion.
Our study is unique because it includes strict exclusion criteria designed to prevent participation by patients with conditions that might alter pain perception and because it was conducted using a standardized insertion technique, by a single examiner, designed to limit examination variability. Because of the exclusion criteria, over 92% of study participants had speculum examinations as part of their annual gynecologic “well-woman” evaluation (Table 1), which represents a common reason women undergo speculum examination. We believe our results are generalizable to women undergoing speculum examinations elsewhere.
A limitation of this investigation is the inability to perform a double-blinded study, because it was not possible to blind the examiner to how the speculum was prepared, which might introduce examiner bias. The standardized examination technique was designed to limit this. Although not a limitation of the study, we were unable to compare pain scores for different types or sizes of specula, other lubricant brands, different amounts of lubricant, lubricant temperature, or speed of speculum insertion or withdrawal. Furthermore, we are unable to determine if gel affects pain for other populations who may be more likely to have pain with speculum insertion, including postmenopausal or virginal patients. Assessing the influence of lubricants on these variables is worthy of future study.
We chose a 0.9-cm mean difference in the visual analog scale results as clinically significant because of previous research suggesting that this is a minimally clinically significant difference in visual analog scale scores.11,12 Much of the research using visual analog scales comes from patients in acute pain cared for in emergency departments,11,12,19 which is a different type of patient population than we studied. Nevertheless, we recognize that our findings of a 0.74-cm mean difference in the visual analog scale score reached statistical significance but may not be clinically significant. Assessment of pain for patients involving relatively minor procedures such as speculum insertion deserves further study to determine the minimally clinically significant difference of visual analog scale scores. We believe that our findings of significantly reduced pain on the visual analog scale and that over one-third of patients in the gel group reported a zero score on the visual analog scale, compared with only 10% of patients in the water arm, suggest that lubricating gel is a valuable method of reducing patient discomfort.
There are several randomized studies verifying that lubricant use does not affect Pap test adequacy.5–7 Although our study was not designed to estimate the effect of gel on Pap test adequacy, it is reassuring that there were no unsatisfactory results in any of the 73 patients who had Pap screening. Importantly, one manufacturer of liquid-based cytology recommends avoiding lubricants containing “carbomers” or “carbopol polymers,” which may interfere with liquid-based Pap tests, and provides online information about which lubricant products do not contain these chemicals.9
Many clinicians are using water to lubricate the speculum, which is not as comfortable for patients as using lubricating gel. Some patients may be afraid to have speculum examinations as a result of concern about pain, which is a barrier to cervical cytology and sexually transmitted infection testing. Changing longstanding practice patterns can be difficult. However, over the course of our careers, we commonly alter how we practice based on new evidence. Part of our responsibility to our patients is to perform the gentlest examination possible. We encourage clinicians to adopt lubricating gel as the standard practice when performing speculum examinations.
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© 2012 by The American College of Obstetricians and Gynecologists.