Craniosynostosis Patient-Reported Outcomes Using the FACE-Q Scales: A Prospective Observational Study
K
Katelyn Makar
Primary Investigator
Enrolling By Invitation
21 years or below
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Craniosynostosis can affect normal brain development by causing local or regional increases in intracranial pressure. The goals of surgery in the treatment of craniosynostosis are to improve the appearance and morphology of the skull and to prevent functional disturbances such as intracranial hypertension and ophthalmologic complications. The proposed study aims to use the FACE-Q Craniofacial Module to assess long-term patient-reported outcomes regarding satisfactions with their appearance and quality of life after surgery to repair craniosynostosis. The FACE-Q Craniofacial modules provides a validated method of collecting satisfaction data for patients, using appearance and quality-of-life variables which are relevant and meaningful for patients and parents.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potentially eligible patients and their parents/guardians will be approached in clinic in IU Health facilities by study staff about study participation.
Detailed description of study
What will happen during the study?
- Parent/guardian/patient will complete consent/assent/authorization and questionnaires either in person on paper or tablet. Patients who are >7 years old and can understand the study and what they are required to do will have the option to complete their own questionnaire; otherwise, the parent/guardian will complete the questionnaire on the patient’s behalf.
- The questionnaire requires approximately 7 minutes to complete and includes 16 modules of the total 29 FACE-Q Craniofacial modules: cheeks, chin, eyes, face, forehead, head shape, jaws, nose, smile, teeth, appearance distress, psychological, school, social, breathing, and eye function.
- For patient who is scheduled to have surgery, the parent/guardian/patient will complete the questionnaire once, before the date of surgery, to establish baseline measurement. After surgery, the parent/guardian/patient will complete the questionnaire at each of their standard-of-care follow-up visits.
- For patients who already had surgery in the past, the parent/guardian/patient will complete the questionnaire at each of their standard-of-care follow-up visits.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Craniosynostosis, Riley
-
Age: 21 years or below
-
Gender: All
Inclusion criteria
- All patients who have been diagnosed with craniosynostosis at IU Health facilities.
- Had surgery to repair craniosynostosis or is scheduled to have surgery to repair craniosynostosis.
Updated on
23 Apr 2025.
Study ID: SURG-IIR-22819, 22819
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