ACTITUD1: Pelvic Floor Dysfunctions and Female Athletes

Sponsor
University of the Balearic Islands (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05812170
Collaborator
Fundació d'investigació Sanitària de les Illes Balears (Other), Consejo Superior de Deportes (Other)
400
1
2
2
199.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational online session about PF
N/A

Detailed Description

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). Also, a 3D realistic virtual model of pelvic floor structures will be used.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group.
Masking:
None (Open Label)
Masking Description:
The design of this study does not allow to mask participants, care providers, investigators or outcomes assessors.
Primary Purpose:
Prevention
Official Title:
Awareness, Control and Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Educational online session about PF

Participants will attend an 90-minutes educational online session.

Behavioral: Educational online session about PF
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).

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge about pelvic floor [One month]

    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).

  2. Detrimental practices related to pelvic floor dysfunctions [One month]

    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.

  3. Healthy practices to care pelvic floor [One month]

    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.

Secondary Outcome Measures

  1. Gender stereotypes [One month]

    Change in number of existing gender stereotypes that potentially influence PFD, after attending the online educational session and compared to those athletes who do not attend educational session.

  2. PFD auto-reported diagnosis [One month]

    It will be considered if PFD is auto-reported through the questionnaire that athletes will reply. To this end, athletes will reply five yes-no questions regarding the existence of PFD. In case of affirmative response in any of these diagnostic questions by an athlete, it will be considered that this athlete has a PFD. Between-group differences were considered.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Non-applicable

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of the Balearic Islands Palma De Mallorca Balearic Islands Spain 07122

Sponsors and Collaborators

  • University of the Balearic Islands
  • Fundació d'investigació Sanitària de les Illes Balears
  • Consejo Superior de Deportes

Investigators

  • Principal Investigator: Natalia Romero-Franco, PhD, University of the Balearic Islands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of the Balearic Islands
ClinicalTrials.gov Identifier:
NCT05812170
Other Study ID Numbers:
  • 124CER19
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of the Balearic Islands
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023