Improving Informed Consent for Cleft Palate Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02595307|
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cleft Palate Jaw Abnormalities Maxillofacial Abnormalities Mouth Abnormalities Congenital Abnormalities Jaw Diseases Musculoskeletal Diseases Craniofacial Abnormalities Musculoskeletal Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities||Behavioral: Pamphlet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Written pamphlet outlining the risks of surgery as discussed in consultation.
No Intervention: No Pamphlet
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.
- Number of risks recalled [ Time Frame: 3 weeks ]The number of risks that are recalled by the patient at a 3 week follow up phone call.
- Participant Satisfaction as measured with the visual-analogue scale [ Time Frame: 3 months ]Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595307
|Contact: Michael Bezuhly, MD FRCSC||902-470-8168||Michael.Bezuhly@iwk.nshealth.ca|
|Contact: Mona Al-Taha, MD Candidatefirstname.lastname@example.org|
|Canada, Nova Scotia|
|IWK Health Center||Recruiting|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Contact: Bev White (902) 470-8520 email@example.com|
|Principal Investigator: Michael Bezuhly, MD FRCSC|
|Sub-Investigator: Paul Hong, MD FRSCS|
|Sub-Investigator: Mona Al-Taha, MD Candidate|
|Principal Investigator:||Michael Bezuhly, MD FRCSC||IWK Health Centre|