Clinical trial NCT04153500: Validation of a Female Pelvic Floor Interactive Training Model
Official title: Validation of a Female Pelvic Floor Interactive Training Model: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology
timeFrame: 15 months
Secondary outcomes:
measure: Satisfaction with Pelvic+ methodology compared to traditional methodology
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Estudis Salut
Study officials:
affiliation: IES
name: Ana Pereda, Dr
role: PRINCIPAL_INVESTIGATOR
References: