Hilal Ziad, Alici Ferizan, Tempfer Clemens B, Seebacher Veronika, Rezniczek Günther A
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.
Obstet Gynecol. 2017 Aug;130(2):411-419. doi: 10.1097/AOG.0000000000002127.
To test whether video colposcopy reduces anxiety among patients undergoing colposcopy.
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.
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.
Video colposcopy does not reduce anxiety in women undergoing colposcopy.
ClinicalTrials.gov, NCT02697175.
测试阴道镜检查视频是否能减轻接受阴道镜检查患者的焦虑情绪。
在一项前瞻性、随机多中心试验中，我们按一对一比例比较了阴道镜检查视频组和无视频组。使用状态-特质焦虑量表在阴道镜检查前（S1）和检查后（S2）测量特定情境焦虑。主要终点是特定情境焦虑评分的降低（ΔS = S2 - S1）。次要终点包括阴道镜检查期间及检查后10分钟的疼痛、总体不适感、阴道镜检查期间的焦虑、对检查相关信息的满意度以及总体满意度（11项视觉模拟量表）。分析采用意向性分析。计划每组样本量为104例（n = 208），以80%的检验效能检测主要结局中标准差为12.3、差值为4.8的差异。
2016年8月至2017年3月期间，225名女性被随机分组。阴道镜检查视频组111名女性的平均ΔS为-10.3±11.3标准差，无视频组105名女性的平均ΔS为-10.3±11.0标准差（P = 0.50）。次要终点方面，检查期间疼痛（中位数2[四分位间距1 - 3]与2[1 - 4]；P = 0.91）、检查后10分钟疼痛（1[0 - 3]与1[0 - 2.5]；P = 0.24）、总体不适感（3[1 - 5]与3[1 - 5]；P = 0.90）、检查期间焦虑（3[1 - 5]与3[1 - 5]；P = 0.61）、对检查相关信息的满意度（10[9 - 10]与10[9 - 10]；P = 0.88）以及总体满意度（10[9 - 10]与10[9 - 10]；P = 0.54）在两组间也无差异。在多变量线性回归分析中，研究中心（P = 0.028）、体重指数（P = 0.033）和吸烟状况（P = 0.025）独立影响焦虑的降低。
阴道镜检查视频并不能减轻接受阴道镜检查女性的焦虑情绪。
ClinicalTrials.gov，NCT02697175
