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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamphlet | Experimental | Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation. |
|
| No Pamphlet | No Intervention | Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamphlet | Behavioral | Written pamphlet outlining the risks of surgery as discussed in consultation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of risks recalled | The number of risks that are recalled by the patient at a 3 week follow up phone call. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction as measured with the visual-analogue scale | Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Bezuhly, MD FRCSC | Contact | 902-470-8168 | Michael.Bezuhly@iwk.nshealth.ca | |
| Mona Al-Taha, MD Candidate | Contact | 902-441-8300 | mona.altaha@dal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Bezuhly, MD FRCSC | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Center | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21093107 | Background | Aremu SK, Alabi BS, Segun-Busari S. The role of informed consent in risks recall in otorhinolaryngology surgeries: verbal (nonintervention) vs written (intervention) summaries of risks. Am J Otolaryngol. 2011 Nov-Dec;32(6):485-9. doi: 10.1016/j.amjoto.2010.09.012. Epub 2010 Nov 19. | |
| 20231645 | Background | Nadeau DP, Rich JN, Brietzke SE. Informed consent in pediatric surgery: Do parents understand the risks? Arch Otolaryngol Head Neck Surg. 2010 Mar;136(3):265-9. doi: 10.1001/archoto.2010.5. |
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Aggregate results only will be shared.
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| 8490411 | Background | Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90. doi: 10.1136/bmj.306.6882.885. |
| 23336609 | Background | Leclercq WK, Keulers BJ, Houterman S, Veerman M, Legemaate J, Scheltinga MR. A survey of the current practice of the informed consent process in general surgery in the Netherlands. Patient Saf Surg. 2013 Jan 21;7(1):4. doi: 10.1186/1754-9493-7-4. |
| 20372902 | Background | Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010 Jul;34(7):1406-15. doi: 10.1007/s00268-010-0542-0. |
| 12431168 | Background | Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. doi: 10.1001/archotol.128.11.1269. |
| 21199416 | Background | Siau D, List RJ, Hussin N, Woolford TJ. Do printed information leaflets improve recall of the procedure and risks in adult tonsillectomy? How we do it. Clin Otolaryngol. 2010 Dec;35(6):503-6. doi: 10.1111/j.1749-4486.2010.02227.x. No abstract available. |
| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| D007569 | Jaw Abnormalities |
| D019767 | Maxillofacial Abnormalities |
| D009056 | Mouth Abnormalities |
| D000013 | Congenital Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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