David A Hill1, Michael L Cacciatore2, Georgine Lamvu2. 1. Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, Florida Hospital Orlando, Orlando, USA; Department of Obstetrics and Gynecology, University of Central Florida College of Medicine, Orlando, USA. Electronic address: d.ashley.hill.md@flhosp.org. 2. Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, Florida Hospital Orlando, Orlando, USA; Department of Obstetrics and Gynecology, University of Central Florida College of Medicine, Orlando, USA.
Abstract
OBJECTIVE: To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination. METHODS: We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale. RESULTS: There were no substantial demographic differences between the standard (n=67) and the sheathed (n=68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1%±8.2% vs. 78.2%±18.4%; P<0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P<0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P=0.087). CONCLUSION: A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort. ClinicalTrials.gov:NCT01670630.
RCT Entities:
OBJECTIVE: To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination. METHODS: We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale. RESULTS: There were no substantial demographic differences between the standard (n=67) and the sheathed (n=68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1%±8.2% vs. 78.2%±18.4%; P<0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P<0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P=0.087). CONCLUSION: A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort. ClinicalTrials.gov:NCT01670630.
Authors: Mercy Nyamewaa Asiedu; Júlia Agudogo; Marlee S Krieger; Robert Miros; Rae Jean Proeschold-Bell; John W Schmitt; Nimmi Ramanujam Journal: PLoS One Date: 2017-05-31 Impact factor: 3.240