An interventional study of Pamphlet in Cleft Palate, Jaw Abnormalities and Maxillofacial Abnormalities, sponsored by IWK Health Centre. Status unknown at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-03-08.
Sponsored by IWK Health Centre · Not applicable, Interventional, and Supportive care
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.
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 40 is close to the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →IWK Health Centre is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant group that will receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Behavioral: Pamphlet
Patient group that will not receive a written pamphlet outlining the risks of surgery as discussed in consultation.
Written pamphlet outlining the risks of surgery as discussed in consultation.
Number of risks recalled
The number of risks that are recalled by the patient at a 3 week follow up phone call.
Time frame: 3 weeks
Participant Satisfaction as measured with the visual-analogue scale
Participants' perceived satisfaction with the procedure as measured with the visual-analogue scale.
Time frame: 3 months
Plan to share: No — Aggregate results only will be shared.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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