Validation of a Female Pelvic Floor Interactive Training Model

NCT ID: NCT04153500

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-04-27

Brief Summary

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

Detailed Description

Objectives:

• To evaluate the residents' knowledge of the female pelvis anatomy at 3 months post intervention.
• To determine residents' satisfaction with Pelvic+ methodology compared to traditional methodology.

Material and Method:

Design: A multicentre, two arms, parallel randomized controlled trial (RCT) of an educational intervention to compare knowledge on female pelvis anatomy between Pelvic+ methodology and traditional methodology at baseline, at completion of intervention and at 3 months post-intervention.

Setting:

Teaching Unit of Midwifery of Catalonia. Institut d'Estudis Sanitaris, Barcelona, Spain.

Participants: Midwives in their 1st year of training.

Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 68 subjects are necessary in first group and 68 in the second to recognize as statistically significant a difference greater than or equal to 1.66 units. The common standard deviation is assumed to be 2.17 and the correlation coefficient between the initial and final measurement as 0.0001. It has been anticipated a drop-out rate of 20%.

Randomisation:

Prior to randomisation, consenting Teaching Unit will provide a list of their current residents' caseload. The number of participants on that caseload who meet the inclusion criteria, will be entered into the random numbers generator to create a randomly list in which to approach potential participants to intervention group or control group. Following the random list, sealed envelopes will be prepared. When the participant approach, second researcher will then seek informed consent to participate in the RCT consecutively. Once the participant has signed the informed consent to participate in the RCT, the first sealed envelope will be given to her/him sequentially.

The information contained in the sealed envelope will allocate the participant to room A or B. Being A: control group; and B: intervention group.

In situations where a participant, who had previously signed the informed consent and, before running the intervention session, decides to withdraw the study, will be removed from the RCT.

Blinding:

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.

Intervention: Pelvic+ methodology 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.

Control group: Traditional methodology A professor/lecturer of anatomy will carry out the session in the control group.

The traditional session 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.

Conditions

Pelvic Floor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Traditional Methodology

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pelvic+ method

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.

Group Type: EXPERIMENTAL

Anatomy class with Pelvic+ methodology

Intervention Type: OTHER

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

Interventions

Anatomy class with Pelvic+ methodology

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. registered midwives,

2. residents who have previously undertake another residence

3. residents who have done their Final Work Grade on pelvic floor,

4. residents who have done pelvic dissection during their grade studies

5. traditional methodology using anatomical models.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Autonoma de Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Ana Pereda

Gynecologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Pereda, Dr

Role: PRINCIPAL_INVESTIGATOR

IES

Locations

Institut Estudis Salut

Barcelona, , Spain

Countries

Spain

Other Identifiers

CEEAH 4764

Identifier Type: -

Identifier Source: org_study_id