NCT04840329

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 7, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

April 7, 2021

Last Update Submit

February 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in menstrual health and endometriosis knowledge

    Assessed using a built for purpose questionnaire, possible scores range from 0 to 8

    Baseline and 4 weeks

Secondary Outcomes (7)

  • Change from baseline in prioritization of menstrual health

    Baseline and 4 weeks

  • Change from baseline in confidence in endometriosis knowledge

    Baseline and 4 weeks

  • Change from baseline in comfort with menstrual health

    Baseline and 4 weeks

  • Acceptability of menstrual health and endometriosis education (quantitative)

    Immediately following education in intervention and waitlist control group

  • Acceptability of menstrual health and endometriosis education (qualitative)

    Immediately following education in intervention and waitlist control group

  • +2 more secondary outcomes

Study Arms (2)

Education Arm

EXPERIMENTAL
Behavioral: Education

Waitlist Control Arm

NO INTERVENTION

Interventions

EducationBEHAVIORAL

One-time educational session about menstrual health and endometriosis

Education Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • grade level class

You may not qualify if:

  • Instruction offered in a language other than English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Paul Yong

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

April 9, 2021

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations