The Effect of Written Information on Recall of Surgical Risks of Primary Cleft Palate Repair: A Randomized Controlled Study.

Objective: To investigate parents' understanding of the risks of primary cleft palate surgery after counseling with and without the use of a written informational aid.

Design: Prospective, randomized, single-blind trial.

Setting: Academic tertiary care center.

Participants: Parents of children undergoing primary cleft palate surgery.

Interventions: Parents were randomized to receive a standard informed consent discussion with or without provision of a written informational aid in the form of a pamphlet.

Main Outcomes Measure: Parents' recall of 9 specific surgical risks 3 weeks after informed consent discussion.

Results: Forty parents enrolled in and completed the study (20 participants each in the control and intervention groups). There were no statistically significant differences between groups in terms of baseline demographics. The mean number of risks recalled were 3.7 (1.6) for the control group and 4.2 (1.9) for the intervention group ( = .37). The most commonly recalled risks were fistula formation and bleeding, while the least frequent were facial growth restriction and need for further surgery. No differences in risk recall were observed based on participant's gender, level of education, or income.

Conclusion: Parents of children undergoing primary cleft palate surgery recall less than 50% of counseled risks. The use of a written aid in the form of a pamphlet did not significantly improve recall in this sample. These results demonstrate that surgeons should implement additional measures to improve comprehension of surgical risks.