Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD (ACTITUD)

October 9, 2024 updated by: University of the Balearic Islands

Educational Intervention Related to Pelvic Floor Care in Females in Sport

Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.

New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.

To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology.

Study Overview

Status

Completed

Detailed Description

The educational intervention consisted on three 60-minutes online sessions, organized as follows:

Session 1: anatomical information about pelvic floor and exercises about pelvic floor consciousness; Session 2: function and dysfunction of pelvic floor and exercises related; Session 3: risk factor for pelvic floor dysfunctions and exercises to strengthen the pelvic floor musculature.

Study Type

Interventional

Enrollment (Actual)

400

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

    • Balearic Islands
      • Palma De Mallorca, Balearic Islands, Spain, 07122
        • University of the Balearic Islands

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

Yes

Description

Inclusion Criteria:

  • To train and compete in any of the sport modality.
  • To have federative license from a regional or national sport federation in the season when study starts.

Exclusion Criteria:

  • Non applicable

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education about PF
Education about PF. Participants will attend three 60-minutes educational online sessions.
The three educational sessions will last 60 minutes, as follows: session1, anatomy of pelvic floor; session2, function and dysfunction of pelvic floor; session3, risk factor for pelvic floor dysfunctions.
No Intervention: Control
Despite the fact that all females will be invited to participate in the study, those who did not attend the educational sessions will be considered as control group. These participants will not receive any educational session or information about PF prior to be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about pelvic floor
Time Frame: One month
Change in the level of knowledge about pelvic floor according to the responses to an online questionnaire after attending the online educational sessions and compared to those females who do not attend educational sessions. 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
Habits related to pelvic floor dysfunctions
Time Frame: One month
Change in number of habits that participants often carry out during their daily life, potentially related to pelvic floor dysfunctions, after attending the online educational sessions and compared to those athletes who do not attend educational sessions.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender stereotypes beliefs
Time Frame: One month
Change in the score related to gender stereotypes beliefs, after attending the online educational sessions and compared to those females who do not attend educational sessions. This score will be obtained after the sum of the factor1 and factor3 from the validated questionnaire CEGAFD (in English: beliefs and gender-based stereotypes concerning physical activity and sport). For the factor1 and factor3, females will rate from 1(completely disagree) to 4 (completely agree) to 7 and 5 gender stereotypes statements, respectively. The sum of the two factors will be the score of gender stereotypes beliefs (from 12 points as minimal gender stereotypes beliefs - 7 points for factor1 and 5 points for factor3 -, to 48 points as the maximal gender stereotypes beliefs - 28 points for factor1 and 20 points for factor3).
One month
Occurrence of symptoms related to pelvic floor dysfunctions
Time Frame: One month
It will be considered if pelvic floor dysfunction is self-reported through the questionnaire that athletes will reply. To this end, athletes will reply five yes-no questions regarding the occurrence of the main symptoms related to pelvic floor dysfunctions. In case of affirmative response in any of these diagnostic questions, it will be considered that this athlete has the symptom related to pelvic floor dysfunction. Between-group differences were considered.
One month

Collaborators and Investigators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2024

Primary Completion (Actual)

May 22, 2024

Study Completion (Actual)

June 20, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 6, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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