Validation of a Female Pelvic Floor Interactive Training Model

NCT04153500 | Completed

• 1 other identifier: CEEAH 4764
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Residents increase their knowledge of female pelvis anatomy using a pelvic floor interactive model methodology (Pelvic+) compared to the traditional methodology.

Conditions

Pelvic Floor

Outcome Measures

Primary Outcomes (1)

• Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology

  The primary outcome of change of knowledge of the female pelvis anatomy at three months post-intervention with Pelvic+ methodology compared to traditional methodology will be measured by a self-completed questionnaire that will be completed by participants in both control and intervention groups prior to the teaching session and then three months post teaching. The following five anatomical topics will be researched: 1. bone structure and obstetrical landmarks 2. ligament structure 3. superficial perineal muscle 4. deep pelvis muscle 5. nerves. Each of the above anatomical topics will be assessed with three questions using a Likert type scale, the total mean scores for each of the anatomical topics pre teaching and at three months post teaching for both the intervention and control groups will then be compared and analysed for comparison between the intervention and control goups.

  15 months

Secondary Outcomes (1)

• Satisfaction with Pelvic+ methodology compared to traditional methodology

  1 year

Study Arms (2)

Traditional Methodology

NO INTERVENTION

A professor/lecturer of anatomy will carry out the session in the control group. The traditional (40 minutes total) will consist of 30 minutes of lecture (75% out of the total time), where female pelvic floor will be presented throughout theory and images. In the 2nd part, during 10 min (25%), participants will review anatomical drawings /atlases.

Pelvic+ method

EXPERIMENTAL

The second researcher will carry out the session in the intervention group. The interventional session (40 minutes total) will consist of two parts: The 1st one is a lecture of 10 minutes (25% out of the total time) on female pelvic floor anatomy. In the 2nd part, during 30 min (75%), participants, in small groups of 4 people, will assemble the female pelvic floor interactive model, following the indications suggested by the second researcher. Pelvic+ is supported by an assembling manual that participants will be allowed to use.

Other: Anatomy class with Pelvic+ methodology

Interventions

Anatomy class with Pelvic+ methodology OTHER

Teaching of female pelvis anatomy using a interactive training model (Pelvic+ methodology)

Pelvic+ method

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• midwives in their 1st year of training and who wish to participate and sign the informed consent document.

You may not qualify if:

• registered midwives,
• residents who have previously undertake another residence
• residents who have done their Final Work Grade on pelvic floor,
• residents who have done pelvic dissection during their grade studies
• traditional methodology using anatomical models.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead

Study Sites (1)

Institut Estudis Salut

Barcelona, 08005, Spain

Location

Study Officials

• Ana Pereda, Dr

  IES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Principal investigator and the statistician will remain blind to group allocation. Outcome assessments will only be conducted by principal investigator blind to the intervention and control groups. Second researcher and professor will remain blind to questions included in both questionnaires: anatomy and satisfaction.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: November 6, 2019
• Study Start: November 25, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 27, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)