NCT07356401 Associations of Cranial Outcomes and Parental Expectations and Satisfaction
| NCT ID | NCT07356401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gulhane School of Medicine |
| Condition | Plagiocephaly |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-11-25 with a primary completion date of 2026-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07356401 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 18 Months, studying Plagiocephaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356401 currently recruiting?
Yes, NCT07356401 is actively recruiting participants. Contact the research team at gulluaydin23@gmail.com for enrollment information.
Where is the NCT07356401 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07356401 clinical trial?
NCT07356401 is sponsored by Gulhane School of Medicine. The trial plans to enroll 20 participants.