Associations of Cranial Outcomes and Parental Expectations and Satisfaction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorGulhane School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cranial orthosis

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators