Department of Medicine, McMaster University, Hamilton, Ontario.
McMaster University, Faculty of Nursing, Hamilton, Ontario.
Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e634-e641. doi: 10.1097/MEG.0000000000002186.
To assess the feasibility of a randomized controlled trial (RCT), evaluating the efficacy and patients' perceptions of a psychological intervention aimed at reducing anxiety levels in adults undergoing first-time colonoscopy.
Adults undergoing first-time colonoscopy were randomized to a psychological intervention vs. sham intervention. The primary outcome was feasibility, defined as a recruitment rate of >50%. Patients' state anxiety was assessed before and after the intervention using the state-trait inventory for cognitive and somatic anxiety (STICSA) score. Follow-up interviews were performed within 1 week with a sample of patients and focus groups with clinical staff.
A total of 130 patients were recruited from 180 eligible patients (72%). Eighty were randomized and completed the study (n = 39) in the psychological intervention group and (n = 41) in the sham. In the psychological intervention group, pre- and postmedian STICSA scores were 29 and 24 (P < 0.001), respectively. In the sham group, pre- and postmedian scores were 31 and 25 (P < 0.001), respectively. Follow-up interviews with patients (n = 13) suggested that 100% of patients perceived the psychological intervention as beneficial and would recommend it to others.
The study was feasible. Patients in both groups improved their anxiety scores, but there were no significant differences between arms. Despite this, patients receiving psychological intervention perceived a benefit from the relaxation exercises.
评估一项随机对照试验（RCT）的可行性，该试验评估了一种旨在降低首次接受结肠镜检查的成年人焦虑水平的心理干预措施的疗效和患者感知。
首次接受结肠镜检查的成年人被随机分配至心理干预组或假干预组。主要结局是可行性，定义为招募率>50%。使用状态特质焦虑量表（STICSA）评分在干预前后评估患者的状态焦虑。对部分患者进行了 1 周内的随访访谈，并对临床工作人员进行了焦点小组讨论。
从 180 名符合条件的患者中招募了 130 名患者（72%）。80 名患者被随机分组并完成了研究（n=39）在心理干预组和（n=41）在假干预组。在心理干预组，STICSA 评分的中位数分别为 29 和 24（P<0.001）。在假干预组，STICSA 评分的中位数分别为 31 和 25（P<0.001）。对患者（n=13）进行的随访访谈表明，100%的患者认为心理干预有益，并将向他人推荐。
该研究是可行的。两组患者的焦虑评分均有所改善，但组间无显著差异。尽管如此，接受心理干预的患者还是从放松练习中感受到了益处。
