NCT02595307

Improving Informed Consent for Cleft Palate Repair

Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Cleft Palate
• Jaw Abnormalities
• Maxillofacial Abnormalities
• Mouth Abnormalities
• Congenital Abnormalities
• Jaw Diseases
• Musculoskeletal Diseases
• Craniofacial Abnormalities
• Musculoskeletal Abnormalities
• Stomatognathic Diseases
• Stomatognathic System Abnormalities

Interventions

Type	Name	Description
BEHAVIORAL	Pamphlet	Written pamphlet outlining the risks of surgery as discussed in consultation.

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2015-11-03
• Last updated: 2017-03-08

Locations

1 site across 1 country: Canada