Associations of Cranial Outcomes and Parental Expectations and Satisfaction (NCT07356401) | Clinical Trial Compass
RecruitingNot Applicable
Associations of Cranial Outcomes and Parental Expectations and Satisfaction
Turkey (Türkiye)20 participantsStarted 2025-11-25
Plain-language 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.
Who can participate
Age range
3 Months – 18 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cranial morphological measurements following cranial remolding orthosis treatment