Comparison Between Multimedia and Written Informed Consent for Lumbar Transforaminal Epidural Steroid Injection: A Randomized Controlled Pilot Trial.

Abstract

Background: Informed consent is a crucial ethical and legal requirement in medical practice to ensure that patients understand the risks, benefits, and alternatives of medical procedures. Recent advances in multimedia technology have facilitated the exploration of multimedia consent, aiming to enhance patient understanding and satisfaction. Ascertaining that patients have full comprehension of the procedures before opting to undergo them is especially important now that instances of such procedures as lumbar transforaminal epidural steroid injections (TESIs) are increasing.

Objectives: To determine the effectiveness of multimedia consent forms for lumbar transforaminal steroid injections.

Study design: Randomized clinical trial.

Setting: Outpatient multidisciplinary pain medicine center of a tertiary hospital.

Methods: A randomized controlled trial was conducted with 30 patients who received lumbar TESIs for lumbar radiculopathy. Patients were randomly assigned to either the multimedia consent group (Group M) or the conventional paper consent group (Group C). This study evaluated patients' comprehension of the procedure, their anxiety levels (using the State-Trait Anxiety Inventory short form), and the patients' post-procedure satisfaction.

Results: Group M showed significantly greater understanding of the procedure and reported lower levels of anxiety than did Group C (P = 0.041; P = 0.03). However, there were no statistically significant differences in post-procedure satisfaction between the groups (P = 0.25). These findings suggest that multimedia consent can effectively improve patient comprehension and reduce anxiety without significantly affecting patient satisfaction.

Limitations: First, the limited sample size of 30 patients restricts the applicability of our findings to a wider population, suggesting a need for larger studies to better assess the effects of multimedia consent. Second, conducting the study in a single hospital might have introduced bias. Multicenter research may provide a more diverse and accurate evaluation of the efficacy of multimedia consent.

Conclusion: This pilot study contributes to the growing evidence supporting the use of multimedia consent to enhance patient understanding and reduce anxiety, marking a promising direction for improving informed consent practices for less invasive procedures, such as lumbar TESIs. Further research is required to fully explore the benefits and limitations of multimedia consent forms in various medical settings.