Ziad Hilal1, Ferizan Alici, Clemens B Tempfer, Veronika Seebacher, Günther A Rezniczek. 1. Department of Obstetrics and Gynecology, Ruhr-Universität Bochum, Bochum, Germany; and the Department of Gynecology and Gynecologic Oncology, Gynecologic Cancer Unit, Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria.
Abstract
OBJECTIVE: To test whether video colposcopy reduces anxiety among patients undergoing colposcopy. METHODS: In a prospective, randomized multicenter trial, we compared video colposcopy and no video colposcopy in a one-to-one 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 analog 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 SD of 12.3 in the primary outcome. RESULTS:Between August 2016 and March 2017, 225 women were randomized. The mean ΔS was -10.3±11.3 SD in 111 women in the video colposcopy group and -10.3±11.0 SD in 105 women without video colposcopy (P=.50). The secondary endpoints pain during examination (median 2 [interquartile range 1-3] compared with 2 [1-4]; P=.91), pain 10 minutes after examination (1 [0-3] compared with 1 [0-2.5]; P=.24), general unpleasantness (3 [1-5] compared with 3 [1-5]; P=.90), anxiety during examination (3 [1-5] compared with 3 [1-5]; P=.61), satisfaction with the information about the procedure (10 [9-10] compared with 10 [9-10]; P=.88), and overall satisfaction (10 [9-10] compared with 10 [9-10]; P=.54) were also not different between the two study groups. In a multivariate linear regression analysis, study center (P=.028), body mass index (P=.033), and smoking status (P=.025) independently affected the reduction of anxiety. CONCLUSION:Video colposcopy does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02697175.
RCT Entities:
OBJECTIVE: To test whether video colposcopy reduces anxiety among patients undergoing colposcopy. METHODS: In a prospective, randomized multicenter trial, we compared video colposcopy and no video colposcopy in a one-to-one 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 analog 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 SD of 12.3 in the primary outcome. RESULTS: Between August 2016 and March 2017, 225 women were randomized. The mean ΔS was -10.3±11.3 SD in 111 women in the video colposcopy group and -10.3±11.0 SD in 105 women without video colposcopy (P=.50). The secondary endpoints pain during examination (median 2 [interquartile range 1-3] compared with 2 [1-4]; P=.91), pain 10 minutes after examination (1 [0-3] compared with 1 [0-2.5]; P=.24), general unpleasantness (3 [1-5] compared with 3 [1-5]; P=.90), anxiety during examination (3 [1-5] compared with 3 [1-5]; P=.61), satisfaction with the information about the procedure (10 [9-10] compared with 10 [9-10]; P=.88), and overall satisfaction (10 [9-10] compared with 10 [9-10]; P=.54) were also not different between the two study groups. In a multivariate linear regression analysis, study center (P=.028), body mass index (P=.033), and smoking status (P=.025) independently affected the reduction of anxiety. CONCLUSION: Video colposcopy does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02697175.