Actively Recruiting

Age: 3Months - 18Months
All Genders
NCT07356401

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

Age: 3Months - 18Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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