知情同意签字对冠状动脉造影患者焦虑情绪的影响

Effect of informed consent on anxiety in patients undergoing coronary angiography

目的 研究知情同意签字对冠状动脉造影患者焦虑情绪的影响。方法 5 8例随机化分为不提及详细并发症知情同意签字的A组 (30例 )和提及详细并发症的B组 (2 8例 )。在知情同意签字前 (1期 )、签字后 (2期 )和造影结束并告知检查结果后 (3期 ) ,用Spielberger焦虑状态 特征自评量表测定患者的焦虑情绪程度。结果 A、B两组患者在签字后焦虑状态计分均明显下降 ,分别由 34 .3± 9.0降至 32 .2± 8.5 (P <0 .0 5 )和 35 .2± 10 .1降至 32 .7± 10 .1(P <0 .0 5 ) ,焦虑特征计分无相似变化。两组间焦虑状态与焦虑特征计分在各期中差异均无显著性。造影后冠状动脉正常组 (17例 )焦虑状态计分由 1期的 34 .6± 8.2降至 2 5 .1± 5 .7(P <0 .0 1) ,焦虑特征计分也由 36 .5± 10 .3降至 31.2± 6 .7(P <0 .0 1)。冠状动脉病变组 (37例 )造影后焦虑状态与焦虑特征计分则无相似改变。结论 知情同意签字能使冠状动脉造影患者焦虑情绪减轻 ,恰当方式提及详细的并发症风险并不增加患者的焦虑情绪。

Objective To observe the effect of a detailed informed consent on anxiety in patients undergoing coronary angiogrpahy. Methods Fifty eight patients (48 men, 10 women, mean age 62±10 years) were randomly assigned to receive either a consent which did not detail specific risks on the procedure (group A, 30 patients) or one which detailed the risks (group B,28 patients). The Spielberger State Trait Anxiety Inventory was made out by the patients themselves before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the coronary angiography procedure when the patient known the results of the angiography (state 3).Results The state anxiety scores at state 2 for the patients was significantly decreased form (34.3±9.0) to 32.2±8.5 ( P <0.05) in group A and from 35.2±10.1 to 32.7±10.1 ( P <0.05) in group B. The anxiety trait scores in both group were unchanged. There was no difference between group A and B at every state or trait anxiety scores. After angiogrpahy procedure, 17 patients with normal coronary artery had a significant decrease in anxiety state scores from 34.6±8.2 at state 1 to 25.1±5.7 at state 3 ( P <0.01) as well as in anxiety trait scores form 36.5±10.3 at state 1 to 31.2±6.7 at state 3( P <0.01). The anxiety state and trait scores in 37 patients with abnormal coronary artery were not changed and the anxiety state score in those patients were much higher than that of patients with normal result 32.1±10.5 vs 25.1±5.7, ( P <0.05). The anxiety trait scores at state 3 in patients with abnormal result did not show the similar change. Conclusion The process of informed consent can reduce the anxiety in patients undergoing coronary angiography, and a consent which detail specific risks in the proper way may not increase anxiety. Thus it should be applied in patients undergoing coronary angiography in our country and would have a beneficial effect.