ABSTRACT
BACKGROUND: Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. METHODS: A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients' level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients' level of pain after the procedure, anxiety and satisfaction of patient and doctor. RESULTS: No positive effect of music on patients' perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. CONCLUSIONS: This study showed no positive effect of music on patients' level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. TRIAL REGISTRATION: Dutch Trial Register, NTR4924.
ABSTRACT
OBJECTIVE: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling. DESIGN: Multicentre, randomised controlled trial. SETTING: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands. POPULATION: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling. METHODS: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management. MAIN OUTCOMES: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered. RESULTS: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer. CONCLUSION: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling. TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.
