Effects of speculum lubrication on cervical smears for cervical cancer screening: a double blind randomized clinical trial

ABSTRACT Background Speculum lubrication may help to reduce the pain experienced during Pap-smears collection and hence increase uptake of cervical cancer screening and repeat testing but there are fears of its interference with cytological results. Aim To determine and compare adequacy of cervical cytology smears and mean pain scores of women undergoing cervical cancer screening with or without speculum lubrication. Methods This was a randomized controlled study of 132 women having cervical cancer screening at a tertiary hospital in Nigeria. Sixty-six participants each were randomly assigned to the ‘Gel’ and ‘No Gel’ groups respectively. Pap-smears were collected from each participant with lubricated speculum (‘Gel group’) or non-lubricated speculum (‘No Gel group’). The primary outcome measures were; the proportion of women with unsatisfactory cervical cytology smears and the mean numeric rating scale pain scores while the secondary outcome measures were the proportion of women that are willing to come for repeat testing and the cytological diagnosis of Pap-smear results. Results The baseline socio-demographic variables were similar in both groups. There was no significant difference in the proportion of unsatisfactory cervical smear results between the two groups (13.6% vs. 21.2% p = 0.359). However, the mean pain scores were significantly lower in the gel group than in the no gel group (45.04 vs 87.96; p0.999) were willing to come for repeat cervical smears in the future. Conclusion Speculum lubrication did not affect the adequacy of cervical-smears but significantly reduced the pain experienced during Pap-smear collection. Also, it did not significantly affect willingness to come for repeat cervical smears in the future. The Trial was registered with Pan-African Clinical Trial Registry with unique identification/registration no: PACTR2020077533364675.