Associations of Cranial Outcomes and Parental Expectations and Satisfaction

Recruiting now

Conditions studied: Plagiocephaly, Cranial Defect, Orthosis, Expectancy, Satisfaction

In brief

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.

Key facts

Study ID: NCT07356401
Run by: Gulhane School of Medicine
People needed: 20
Starts: 2025-11-25
Expected to finish: 2026-03-15
Last updated by the study team: 2026-01-26

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Infants diagnosed with positional cranial deformities (e.g., plagiocephaly, brachycephaly, or asymmetrical cranial shape)
Infants who received cranial remolding orthosis treatment
Use of a custom-made cranial remolding orthosis
Availability of pre-treatment and post-treatment cranial measurements
Parents or legal guardians who provided informed consent and were able to complete expectation and satisfaction questionnaires
Infants who completed the planned cranial remolding orthosis treatment and follow-up period

You may not qualify if…

Infants with neurological disorders, genetic syndromes, or congenital conditions affecting cranial growth
Infants who underwent 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 the questionnaires due to language or cognitive limitations
Infants with a diagnosis of microcephaly or macrocéphaly.

Where it is running

University of Health Sciences Gülhane Faculty of Health Sciences — Ankara, Keçiören, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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