The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract

June 20, 2018 updated by: Haotian Lin, Sun Yat-sen University

The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial

To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhognshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with regulated cataract surgery

Exclusion Criteria:

  • difficulty in understanding the language
  • uncompleted questionnaires or badly filled in by two different people

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interactive, multifaceted approach
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
Other: interactive, multifaceted approach
A health education module consisting of a lecture and workshop was incorporated into a health-care course.
Sham Comparator: conventional approach
conventional follow-up with oral healthy education
Other: conventional approach
conventional follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting stress
Time Frame: 12 months
Parenting stress was assessed using the Parenting Stress Index (PSI)
12 months

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Haotian Lin, Ph.D, Professor

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 (Anticipated)

June 30, 2018

Primary Completion (Anticipated)

July 30, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2018-China-3

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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