NCT05812170

Brief Summary

Pelvic floor dysfunctions (PFD) are especially prevalent among females athletes due to the efforts from sports practice. As conservational management, increasing the athletes' information regard important research lines. However, embarrassment of female athletes limits educational or health demands and facilitate an invisible condition, potentially influenced by gender stereotypes. New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational online session about PFD in the knowledge about it, and practices related with it, existing gender stereotypes and PFD diagnosis of female athletes. To this end, all female athletes who practice Track and Field in Spain will be invited to attend an educational online session with theoretical-practical content about PF. As eligibility criteria, participants should train and compete in any of the Track and Field modalities, and have federative license from regional or national Track and Field Federation at the moment of the start of the study. Participants should have at least 18 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational online session. Before the educational online session, all female athletes will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD auto-reported diagnosis. One month later, this questionnaire will be sent to female athletes (both athletes who attended the educational session or not) to describe changes after attending the online educational session and compared to those athletes who did not attend it. The main outcomes will be the level of knowledge about PF, the number of detrimental practices potentially related to PFD, the number of healthy practices to care PF and existence of influencing gender stereotypes. As an additional outcome, it will be considered the PFD auto-reported diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

October 15, 2024

Status Verified

March 1, 2024

Enrollment Period

21 days

First QC Date

March 31, 2023

Last Update Submit

October 9, 2024

Conditions

Keywords

FemaleAthleteTrack and FieldEducation

Outcome Measures

Primary Outcomes (3)

  • Knowledge about pelvic floor

    Change in the level of knowledge about PF according to the responses to online questionnaire after attending the online educational session and compared to those athletes who do not attend educational session. To assess it, participants will reply an ad-hoc questionnaire with ten multiple-choice questions about pelvic floor structures. It will be counted the number of correct answers (0 points as the worst punctuation, 10 points as the best punctuation).

    One month

  • Detrimental practices related to pelvic floor dysfunctions

    Change in number of detrimental practices that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational session and compared to those athletes who do not attend educational session.

    One month

  • Healthy practices to care pelvic floor

    Change in number of healthy practices to care pelvic floor that participants often carry out during their daily life, after attending the online educational session and compared to those athletes who do not attend educational session.

    One month

Secondary Outcomes (2)

  • Gender stereotypes

    One month

  • PFD auto-reported diagnosis

    One month

Study Arms (2)

Educational online session about PF

EXPERIMENTAL

Participants will attend an 90-minutes educational online session.

Behavioral: Educational online session about PF

Control

NO INTERVENTION

Despite the fact that all athletes will be invited to participate in the study, those who did not attend the educational session will be considered as control group. These participants will not receive any educational session or information about PF prior to be evaluated.

Interventions

The educational online session will last 90 minutes, as follows: 10 minutes of contextualization, 40 minutes of practical content about pelvic floor consciousness and 40 of theoretical content (anatomy and practices related to PFD).

Educational online session about PF

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To train and compete in any of the Track and Field modalities
  • To have federative license from regional or national Track and Field Federation in the season when study starts.

You may not qualify if:

  • Non-applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Natalia Romero-Franco, PhD

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The design of this study does not allow to mask participants, care providers, investigators or outcomes assessors.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

May 15, 2023

Primary Completion

June 5, 2023

Study Completion

July 20, 2023

Last Updated

October 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations