Endocation: Trial of an Endometriosis Education Program

February 16, 2023 updated by: Paul Yong, BC Women's Hospital & Health Centre

Endocation: A Randomized Cluster Controlled Trial of an Endometriosis Education Program for Middle and Secondary School Students

Endometriosis is a common condition that affects 10% of females, causing chronic pain and other health concerns. Currently, it takes 8-12 years to be diagnosed with endometriosis, in part because there is low awareness of this condition. This research is designed to test whether providing endometriosis education in schools can help increase early awareness of the condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

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 Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's 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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 8-12 grade level class

Exclusion Criteria:

  • Instruction offered in a language other than English

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education Arm
One-time educational session about menstrual health and endometriosis
No Intervention: Waitlist Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in menstrual health and endometriosis knowledge
Time Frame: Baseline and 4 weeks
Assessed using a built for purpose questionnaire, possible scores range from 0 to 8
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in prioritization of menstrual health
Time Frame: Baseline and 4 weeks
Assessed using a built for purpose item, possible scores range from 0 to 4
Baseline and 4 weeks
Change from baseline in confidence in endometriosis knowledge
Time Frame: Baseline and 4 weeks
Assessed using a built for purpose item, possible scores range from 0 to 4
Baseline and 4 weeks
Change from baseline in comfort with menstrual health
Time Frame: Baseline and 4 weeks
Assessed using a built for purpose item, possible scores range from 0 to 4
Baseline and 4 weeks
Acceptability of menstrual health and endometriosis education (quantitative)
Time Frame: Immediately following education in intervention and waitlist control group
Assessed using a built for purpose questionnaire, possible scores range from 0 to 35
Immediately following education in intervention and waitlist control group
Acceptability of menstrual health and endometriosis education (qualitative)
Time Frame: Immediately following education in intervention and waitlist control group
Assessed using open-ended responses a built for purpose questionnaire
Immediately following education in intervention and waitlist control group
Refusal of participants invited to participate
Time Frame: Baseline
Number of participants who refuse to participate divided by the number of participants invited to participate
Baseline
Retention of participants
Time Frame: 4 weeks
Number of participants completing the study divided by the number of participants enrolled
4 weeks

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Paul Yong, University of British Columbia

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)

April 9, 2021

Primary Completion (Actual)

May 20, 2021

Study Completion (Actual)

May 20, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H19-00978

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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