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Improving Informed Consent for Cleft Palate Repair

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02595307
Enrollment
40
Registered
2015-11-03
Start date
2014-05-31
Completion date
2017-12-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Risk Recall, Pamphlet, Brochure, Patient satisfaction, Informed Consent

Brief 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.

Interventions

BEHAVIORALPamphlet

Written pamphlet outlining the risks of surgery as discussed in consultation.

Sponsors

IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Parents/guardians of a child referred to the IWK Cleft Palate Clinic for primary cleft palate repair surgery

Exclusion criteria

* Inability to fluently communicate in English * Inability to read at a grade 8 level * Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Number of risks recalled3 weeksThe number of risks that are recalled by the patient at a 3 week follow up phone call.

Secondary

MeasureTime frameDescription
Participant Satisfaction as measured with the visual-analogue scale3 monthsParticipants' perceived satisfaction with the procedure as measured with the visual-analogue scale.

Countries

Canada

Contacts

Primary ContactMichael Bezuhly, MD FRCSC
Michael.Bezuhly@iwk.nshealth.ca902-470-8168
Backup ContactMona Al-Taha, MD Candidate
mona.altaha@dal.ca902-441-8300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026