NCT03564990

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

June 5, 2018

Last Update Submit

June 20, 2018

Conditions

Congenital Cataract

Outcome Measures

Primary Outcomes (1)

  • Parenting stress

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

    12 months

Study Arms (2)

interactive, multifaceted approach

EXPERIMENTAL

A health education module consisting of a lecture and workshop was incorporated into a health-care course.

Other: interactive, multifaceted approach

conventional approach

SHAM COMPARATOR

conventional follow-up with oral healthy education

Other: conventional approach

Interventions

interactive, multifaceted approachOTHER

A health education module consisting of a lecture and workshop was incorporated into a health-care course.

interactive, multifaceted approach
conventional approachOTHER

conventional follow-up

conventional approach

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with regulated cataract surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Haotian Lin, Ph.D

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haotian Lin, Ph.D

CONTACT

+86-20-87330341mailto:haot.lin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 21, 2018

Study Start

June 30, 2018

Primary Completion

July 30, 2018

Study Completion

June 30, 2019

Last Updated

June 21, 2018

Record last verified: 2018-06

Locations

CN(1)