Actively Recruiting
Associations of Cranial Outcomes and Parental Expectations and Satisfaction
Led by Gulhane School of Medicine · Updated on 2026-01-26
20
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Associations of Cranial Outcomes and Parental Expectations and Satisfaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with positional cranial deformities such as plagiocephaly or asymmetrical cranial shape
- Infants who have received cranial remolding orthosis treatment
- Use of a custom-made cranial remolding orthosis
- Availability of cranial measurements before and after treatment
- Parents or legal guardians able to provide consent and complete expectation and satisfaction questionnaires
- Infants who completed the planned CRO treatment and follow-up period
You will not qualify if you...
- Infants with neurological disorders, genetic syndromes, or congenital conditions affecting cranial growth
- Infants who have had previous cranial surgery or other cranial interventions
- Infants who received non-custom-made or prefabricated cranial orthoses
- Incomplete clinical records or missing pre- or post-treatment cranial measurements
- Parents or caregivers unable to complete questionnaires due to language or cognitive limitations
- Infants diagnosed with microcephaly or macrocéphaly
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, Keçiören, Turkey (Türkiye), 06010
Actively Recruiting
Research Team
G
Güllü AYDIN YAĞCIOĞLU, Asst. Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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