Associations of Cranial Outcomes and Parental Expectations and Satisfaction

This study aims to investigate the association between objective cranial morphological changes and parental expectations and satisfaction in infants undergoing treatment with a cranial remolding orthosis (CRO). Infants diagnosed with positional cranial deformities and prescribed CRO treatment will be included. Cranial morphological outcomes will be assessed using standardized cranial measurements obtained before and after the treatment period. Parental treatment expectations will be evaluated prior to the initiation of CRO therapy using the Treatment Expectation Questionnaire (TR.TEX-Q), while parental satisfaction with the device and treatment process will be assessed at the end of treatment using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The primary objective of the study is to examine the relationships between changes in cranial morphology and parental expectations and satisfaction scores. Secondary objectives include exploring the association between baseline expectations and post-treatment satisfaction. The findings are expected to provide insight into how objective treatment outcomes align with family-reported perceptions in cranial remolding orthosis therapy.

NCT Number	NCT07356401
Lead Sponsor	Gulhane School of Medicine
Conditions	Plagiocephaly, Cranial Defect, Orthosis, Expectancy, Satisfaction
Enrollment	20 participants
Start Date	2025-11-25
Primary Completion	2026-02-15 (estimated)
Study Completion	2026-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-26