Emotion‐centered versus fact‐centered medical information to alleviate pain and anxiety in prostate biopsy: A randomized trial

Background To test the efficacy of emotion‐centered (EC) versus fact‐centered (FC) written medical information for prostate biopsy to alleviate pain and anxiety in a randomized controlled trial. Methods In a single‐center, single‐blinded study participants were randomized to receive FC or EC (DRKS00022361; 2020). In the EC, the focus was on possible stress reactions and stress‐reducing strategies. Participants were asked to complete questionnaires on the day of MRI acquisition (T0) directly before (T1) and after the procedure (T2). The primary outcome measure was the assessment of worst pain in the last 2 h measured by the adapted brief pain inventory. Secondary outcome measures included state anxiety measured by the state‐trait anxiety inventory and the subjective evaluation of the impact of the written medical information at T2. For statistical analysis, mixed models were calculated. Results Of 137 eligible patients, 108 (79%) could be recruited and were randomized. There was a significant effect for time for the outcome variables pain and anxiety. Regarding the comparison for the primary outcome variable worst pain there was a significantly lower increase from T1 to T2 after FC compared to EC (p