Improving Informed Consent for Cleft Palate Repair

Status Recruiting

Clinical Trial Summary

To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has any effect on overall satisfaction after the procedure

Clinical Trial Description

The current standard of care as it relates to informed consent in the pediatric population involves providing the parents or guardians of the child undergoing surgery with an oral discussion prior to the surgical procedure. However, providing parents with an oral discussion alone may be insufficient in the informed consent process as it has been shown that oral information tends to be retained poorly and crucial pieces of information tend to be forgotten. Conversely, it has been shown that properly informed patients are more satisfied, have a higher commitment to their treatment, and demonstrate less tendency toward filing legal claims. Furthermore, written material may help reduce anxiety in patients facing stressful events, such as surgery, and have been linked with overall improvement in satisfaction with their treatment

The investigators hypothesize that providing a written document in conjunction with the standard oral discussion improves the participants' risk recall in the informed consent process for their child's cleft palate repair surgery and increases their subjective satisfaction with the operation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02595307
Study type	Interventional
Source	IWK Health Centre
Contact	Michael Bezuhly, MD FRCSC
Phone	902-470-8168
Email	Michael.Bezuhly@iwk.nshealth.ca
Status	Recruiting
Phase	N/A
Start date	May 2014
Completion date	December 2017

View Details

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