Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial.

Study Objective: To determine whether providing additional information to the standard consent process, in the form of a multimedia module (MM), improves patient knowledge about operative laparoscopy without increasing anxiety.

Design: Randomized controlled trial (Canadian Task Force classification I).

Setting: Two outpatient gynecologic clinics, one in a private hospital and the other in a public teaching hospital.

Patients: Forty-one women aged 19 to 51 years (median, 35.6 years) requiring operative laparoscopy for investigation and treatment of pelvic pain.

Intervention: Following the standard informed consent process, patients were randomized to watch the MM (intervention group, n = 21) or not (control group, n = 20). The surgeon was blinded to the group assignments. All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory. Six weeks after recruitment, patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores.

Measurements And Main Results: Patient knowledge of operative laparoscopy, anxiety level, and acceptance of the MM were recorded. The MM intervention group demonstrated superior knowledge scores. Mean (SE) score in the MM group was 11.3 (0.49), and in the control group was 7.9 (0.50) (p <.001) (maximum score, 14). This did not translate into improved knowledge scores 6 weeks later; the score in the MM group was 8.4 (0.53) vs. 7.8 (0.50) in the control group (p = .44). There was no difference in anxiety levels between the groups at intervention or after 6 weeks. Overall, patients found the MM acceptable, and 18 women (86%) in the intervention group and 12 (60%) in the control group stated they would prefer this style of informed consent in the future.

Conclusion: Use of an MM enhances the informed consent process by improving patient knowledge, in the short term, without increasing anxiety.