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

Improving Informed Consent for Cleft Palate Repair

Cleft Palate

Jaw Abnormalities

Maxillofacial Abnormalities

Mouth Abnormalities

Congenital Abnormalities

Jaw Diseases

Musculoskeletal Diseases

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Stomatognathic Diseases

Stomatognathic System Abnormalities

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.

Pamphlet

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

The number of risks that are recalled by the patient at a 3 week follow up phone call.

Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.

Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.

Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.

Improving Informed Consent for Cleft Palate Repair

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?