Results
Women were enrolled at the colposcopy clinic between August 1, 2017 and
January 30, 2018. Of the 20 patients who agreed to participate in the
study, three did not fulfil the inclusion criteria. There were no
differences in the background variables (Table 1) or baseline pain
levels (6.7±2.2 units versus 6.4±3.0 units, respectively; two-tailed
Wilcoxon rank test p = 0.686; data not tabulated) of the sham first
group and trial first group. We used Cronbach’s alpha test to confirm
the statistical validity of calculating the average pain intensity from
the various foci under each condition (Table S1). Then, we tested
whether the manipulation order affected the difference between the
baseline pain level and trial manipulation pain level. For the seven
women in the trial first group, the average change in pain intensity was
0.86. However, for the 10 women in the sham first group, the average
change was 1.5 (P < .512). Therefore, the manipulation order
did not have a significant impact on the change in pain levels.
Following these results, data from all subjects were gathered in one
group. Then, we compared the average pain levels (Table 2) and showed
that posterior fornix pressure led to a statistically significant
decrease in the average pain level elicited by the vestibular Q-tip test
compared with the sham manipulation pain level and baseline pain level
(decreases of 1.12 and 1.13 units in pain intensity, respectively; P =
.003). There was no significant difference between the average baseline
pain level at baseline and sham manipulation pain level (P = .332), as
anticipated. However, the overall decrease in the average pain level
during trial manipulation was 18.4% ± 2.2%, which was below the 30%
threshold that we considered clinically significant (Table S2). Further
examinations of the data revealed that the decrease in the average pain
level ranged between 0% and 78%; in other words, there was at least
one subject who experienced no influence of trial manipulation and some
subjects who experienced a significant influence. Then, we calculated
the overall decrease in the average pain level for the 11 patients who
reported any degree of improvement during trial manipulation, resulting
in an average change of 28.4% ± 2.2%. Five patients experienced more
than 30% improvement in their pain level.