Variable | Stage 2 median scores (IQR) (n=10) | Stage 3 | p value* | |
Intervention† median scores (IQR) (n=11) | Control† median scores (IQR) (n=13) | |||
VAS 1‡ | 0 (0,0) | 3 (1,4) | 2 (1,4) | 0.36 |
VAS 2 | 1 (0,3) | 11.5 (7,15) | 24 (5,35) | 0.58 |
VAS 3§ | 5 (5,18) | 31 (10,48) | 57 (45,64) | 0.13 |
VAS 4 | 16 (10,32) | 27.5 (16,47) | 48 (28,59) | 0.18 |
VAS 5 | 46 (7,66) | 48 (31,68) | 61 (47,75) | 0.40 |
VAS 6 | 8 (0,23) | 32 (22,37) | 40 (31,51) | 0.34 |
VAS 7 | N/A | 17.5 (9,27) | 24 (6,41) | 0.85 |
VAS-FUP¶ | N/A | 0 (0,0) | 0 (0,25) | 0.62 |
*p values are output from Wilcoxon rank sum tests in Stage 3.
†Intervention: women randomised to receive their IUD using the Bioceptive SCR device for cervical traction. Control: women who received their IUD using the single-tooth tenaculum.
‡The 100 mm VAS assesses pain during IUD insertion, with 0 being ‘no pain’ to 100 being the ‘worst pain imaginable’.
§Two patients randomised to the SCR group were omitted from the analysis due to them not receiving their IUDs with the SCR device.
¶Follow-up occurred the day after the procedure. Patients in the Stage 2 did not receive next-day follow-up.
FUP, follow-up; IUD, intrauterine device.