BACKGROUND: informed consent is a fundamental and legal obligation for each interventional cardiologist. The effect of consent form describing risks of invasive procedure on anxiety is controversial. This trial was aimed to assess the added value of video information to the standard informed consent process. METHODS:200 consecutive patients undergoing coronary angiography were enrolled. The first one hundred were assigned to conventional education conducted by the physician (no video group) and the second one hundred had consent obtained in the conventional manner assisted by video information (video group). The outcome variables for this comparison consisted of a standard anxiety score (Spielberger Statement Anxiety Inventory questionnary) plus hemodynamics measurements of heart rate, systolic and diastolic blood pressure obtained at baseline and immediately after written informed consent In addition, before discharge, patients graded the tolerability and satisfaction on a 4-point scale. RESULTS: The groups were similar with regard to their baseline characteristics and anxity score (37+23 vs 37+23). Patients who had not had prior experience of catheterization had higher baseline anxiety than those who had prior angiography (45 + 22 vs 31 + 20; p = 0.027). Patients who watched the video were significantly less anxious after informed consent (28 + 21 vs 34 + 22; p = 0.048) and had a significantly lower heart rate (65 + 10 vs 71 + 12; p = 0.03). The benefits of video information were especially prominent in those with higher anxiety scores at baseline (score after 45 + 24 vs 57 + 26; p = 0.046). Tolerability were higher in the video group compared with no video group (98% vs 86%; p = 0.003). Finally, satisfaction of information for informed consent process was higher in video group than in no video group (99% vs 76%; p = 0.001). CONCLUSION: a video information decreased anxiety level after written informed consent and improved tolerability and satisfaction scales in patients undergoing coronary angiography. The most likely to benefit from video information are patients with higher anxiety level at baseline. Beneficial effect on informed refusal should be investigated in larger population.
RCT Entities:
BACKGROUND: informed consent is a fundamental and legal obligation for each interventional cardiologist. The effect of consent form describing risks of invasive procedure on anxiety is controversial. This trial was aimed to assess the added value of video information to the standard informed consent process. METHODS: 200 consecutive patients undergoing coronary angiography were enrolled. The first one hundred were assigned to conventional education conducted by the physician (no video group) and the second one hundred had consent obtained in the conventional manner assisted by video information (video group). The outcome variables for this comparison consisted of a standard anxiety score (Spielberger Statement Anxiety Inventory questionnary) plus hemodynamics measurements of heart rate, systolic and diastolic blood pressure obtained at baseline and immediately after written informed consent In addition, before discharge, patients graded the tolerability and satisfaction on a 4-point scale. RESULTS: The groups were similar with regard to their baseline characteristics and anxity score (37+23 vs 37+23). Patients who had not had prior experience of catheterization had higher baseline anxiety than those who had prior angiography (45 + 22 vs 31 + 20; p = 0.027). Patients who watched the video were significantly less anxious after informed consent (28 + 21 vs 34 + 22; p = 0.048) and had a significantly lower heart rate (65 + 10 vs 71 + 12; p = 0.03). The benefits of video information were especially prominent in those with higher anxiety scores at baseline (score after 45 + 24 vs 57 + 26; p = 0.046). Tolerability were higher in the video group compared with no video group (98% vs 86%; p = 0.003). Finally, satisfaction of information for informed consent process was higher in video group than in no video group (99% vs 76%; p = 0.001). CONCLUSION: a video information decreased anxiety level after written informed consent and improved tolerability and satisfaction scales in patients undergoing coronary angiography. The most likely to benefit from video information are patients with higher anxiety level at baseline. Beneficial effect on informed refusal should be investigated in larger population.
Authors: Sandra Crouse Quinn; Mary A Garza; James Butler; Craig S Fryer; Erica T Casper; Stephen B Thomas; David Barnard; Kevin H Kim Journal: J Empir Res Hum Res Ethics Date: 2012-12 Impact factor: 1.742
Authors: Philipp Martin Schlechtweg; Matthias Hammon; Christian Heberlein; David Giese; Michael Uder; Siegfried Alexander Schwab Journal: J Digit Imaging Date: 2013-06 Impact factor: 4.056