Recruiting

Observational Study

Sponsor:

IWK Health Centre

Code:

NCT02595307

Conditions

Cleft Palate

Jaw Abnormalities

Maxillofacial Abnormalities

Mouth Abnormalities

Congenital Abnormalities

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Pamphlet

Study Details

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

Conditions

Cleft Palate

Jaw Abnormalities

Maxillofacial Abnormalities

Mouth Abnormalities

Congenital Abnormalities

Study ID

NCT02595307

Start date

May, 2014

Status verified date

Mar, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pamphlet

Participant group that will receive a 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.

Interventions

Pamphlet

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

Primary outcome measure

  • Number of risks recalled [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Michael Bezuhly, MD FRCSC

902-470-8168Michael.Bezuhly@iwk.nshealth.ca

Mona Al-Taha, MD Candidate

902-441-8300mona.altaha@dal.ca

Locations

IWK Health Center

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Bev White

(902) 470-8520bev.white@iwk.nshealth.ca

Principal Investigator:

Michael Bezuhly, MD FRCSC

More Information

Sponsor

IWK Health Centre

Last update posted

Mar 8, 2017

Last verified

Mar, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2017-03-08.