Back to resultsThe Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
Primary Purpose
Congenital Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
interactive, multifaceted approach
conventional approach
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Cataract
Eligibility Criteria
Inclusion Criteria:
- children with regulated cataract surgery
Exclusion Criteria:
- difficulty in understanding the language
- uncompleted questionnaires or badly filled in by two different people
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
interactive, multifaceted approach
conventional approach
Arm Description
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
conventional follow-up with oral healthy education
Outcomes
Primary Outcome Measures
Parenting stress
Parenting stress was assessed using the Parenting Stress Index (PSI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03564990
Brief Title
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
Official Title
The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2018 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.
Detailed Description
Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interactive, multifaceted approach
Arm Type
Experimental
Arm Description
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
Arm Title
conventional approach
Arm Type
Sham Comparator
Arm Description
conventional follow-up with oral healthy education
Intervention Type
Other
Intervention Name(s)
interactive, multifaceted approach
Intervention Description
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
Intervention Type
Other
Intervention Name(s)
conventional approach
Intervention Description
conventional follow-up
Primary Outcome Measure Information:
Title
Parenting stress
Description
Parenting stress was assessed using the Parenting Stress Index (PSI)
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with regulated cataract surgery
Exclusion Criteria:
difficulty in understanding the language
uncompleted questionnaires or badly filled in by two different people
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haotian Lin, Ph.D
Phone
+86-20-87330341
Email
mailto:haot.lin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, Ph.D
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D.
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jing Li, M.D.
Phone
+86-20-87330341
Email
Reviewborad_SYsU@163.com
12. IPD Sharing Statement
Learn more about this trial
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
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