NCT07356401

Associations of Cranial Outcomes and Parental Expectations and Satisfaction

Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Gulhane School of Medicine · Academic / Other
• Sex: All
• Age: 3 Months – 18 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plagiocephaly
• Cranial Defect
• Orthosis
• Expectancy
• Satisfaction

Interventions

Type	Name	Description
DEVICE	Cranial orthosis	The intervention consisted of treatment with a custom-fabricated cranial remolding orthosis (CRO). Each orthosis was individually designed based on the infant's cranial shape using three-dimensional cranial scanning and computer-aided modeling. A mold was produced using CNC technology, and a thermoplastic material was formed over the mold to create the final orthosis. The fabricated CRO was delivered to the clinic within a few days and fitted to the infant. During the initial fitting, the orthosis was clinically inspected for proper fit and for any signs of skin redness, irritation, or pressure-related issues. Necessary adjustments were made, and parents were provided with detailed instructions regarding orthosis use and care. Infants were subsequently scheduled for regular clinical follow-up, and only custom-fabricated cranial remolding orthoses were included in the study.

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-02-15
• Completion: 2026-03-15
• First posted: 2026-01-21
• Last updated: 2026-01-26

Locations

1 site across 1 country: Turkey (Türkiye)