The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03564990
Collaborator
(none)
80
1
2
12
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: interactive, multifaceted approach
  • Other: conventional approach
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial
Anticipated Study Start Date :
Jun 30, 2018
Anticipated Primary Completion Date :
Jul 30, 2018
Anticipated Study Completion Date :
Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Parenting stress [12 months]

    Parenting stress was assessed using the Parenting Stress Index (PSI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children with regulated cataract surgery
Exclusion Criteria:
  • difficulty in understanding the language

  • uncompleted questionnaires or badly filled in by two different people

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03564990
Other Study ID Numbers:
  • CCPMOH2018-China-3
First Posted:
Jun 21, 2018
Last Update Posted:
Jun 21, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2018