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.