To watch or not to watch – does video colposcopy reduce anxiety during colposcopy? A randomized trial

Methodik/Material:

In a prospective, randomized multicenter trial, we compared video colposcopy versus no video colposcopy in a 1:1 ratio. Situation-specific anxiety was measured before (S1) and after (S2) colposcopy using the State-Trait Anxiety Inventory. The primary endpoint was the reduction of the situation-specific anxiety scores (ΔS = S2-S1). Secondary endpoints were pain during and 10 minutes after colposcopy, general unpleasantness, anxiety during colposcopy, satisfaction with the information about the procedure, and overall satisfaction (11-item visual analogue scales). Analysis was by intention to treat. A sample size of 104 per group (N = 208) was planned to achieve 80% power to detect a difference of 4.8 with a standard deviation (SD) of 12.3 in the primary outcome.

Resultate/Ergebnisse:

Between August 2016 and March 2017, 225 women were randomized. The mean ΔS was -10.3 ± SD 11.3 in 111 women in the video colposcopy group and -10.3 ± 11.0 in 105 women without video colposcopy (P = 0.50). The secondary endpoints pain during examination (median 2 [interquartile range 1 – 3] vs. 2 [1 – 4]; P = 0.91), pain 10 minutes after examination (1 [0 – 3] vs. 1 [0 – 2.5]; P = 0.24), general unpleasantness (3 [1 – 5] vs. 3 [1 – 5]; P = 0.90), anxiety during examination (3 [1 – 5] vs. 3 [1 – 5]; P = 0.61), satisfaction with the information about the procedure (10 [9 – 10] vs. 10 [9 – 10]; P = 0.88), and overall satisfaction (10 [9 – 10] vs. 10 [9 – 10]; P = 0.54) were also not different between the two study groups. In a multivariate linear regression analysis, study center (P = 0.028), body mass index (P = 0.033), and smoking status (P = 0.025) independently affected the red.

Schlussfolgerung:

Video colposcopy does not reduce anxiety in women undergoing colposcopy.

 

MissingLinkText