Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence (Cleft social)

August 1, 2024 updated by: Pang-Yun Chou, Chang Gung Memorial Hospital

Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence: Questionnaire Analysis Based on 3dMD Images

Background: Using three-dimensional (3D) surface imaging, this study aims to understand the differences in perception between schoolchildren with and without cleft lip and palate (CLP), as well as to explore peer awareness and acceptance of children with craniofacial abnormalities post-surgery.

Methods: This cross-sectional study utilized three-dimensional surface images of early adolescent patients with CLP post-repair and without CLP for examination by schoolchildren (with CLP and without). Both groups assessed the images and responded to a questionnaire eliciting perceptions of facial appearance and social acceptance of children with craniofacial abnormalities, rating each question on a Likert scale of one to five. The results were presented using bar graphs, and the Item Response Theory-Graded Response Model was employed to estimate the latent ability (θ) of each participant. The reliability of the questionnaire was assessed with Cronbach's alpha test.

Study Overview

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

<Acquisition of 3D Image>

  • Cleft: Images of subjects with and without craniofacial anomalies were extracted from the database at the Chang Gung Craniofacial Research Center; taken before and after alveolar bone graft surgery at a six-month interval, from 2017 to 2020; aged about 9.
  • Noncleft: healthy pediatric individuals from six to 12 years of age. Randomly selected from the database, aged 9-12

<Participants for questionnaires>

  • CLP patients and non-cleft children aged 10-12 were randomly recruited
  • Patients with CLP were sourced from individuals who had undergone surgical treatment and received regular follow-ups in our Craniofacial Center; the non-cleft cases were recruited from various elementary schools in the Guishan district of Taoyuan City, Taiwan.

Description

Inclusion Criteria:

  • Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol

Exclusion Criteria:

  • Unable to complete the questionnaire on their own for any reason were excluded to avoid bias in responses caused by the presence of a secondary observer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cleft lip and palate
Cleft lip and palate patients, undergone surgical treatment and received regular follow-ups in the Chang Gung Craniofacial Center; aged 10-12; after alveolar bone grafting surgery
cleft surgical treatment based on Chang Gung Craniofacial Center Protocol for cleft treatment
Non-cleft
Non cleft cohort as control group; recruited from various elementary schools in the Guishan district of Taoyuan City, Taiwan; aged 10-12; without craniofacial anomalies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial appearance
Time Frame: 6 months after alveolar bone grafting
based on 3dMD image
6 months after alveolar bone grafting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

August 3, 2023

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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