Pelvic FloorNCT04153500
Validation of a Female Pelvic Floor Interactive Training Model
A study testing Anatomy class with Pelvic+ methodology in people with Pelvic Floor, run by Universitat Autonoma de Barcelona at 1 site in Spain.
Trial summary
Residents increase their knowledge of female pelvis anatomy using a pelvic floor interactive model methodology (Pelvic+) compared to the traditional methodology. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor
- What is being tested?
- Anatomy class with Pelvic+ methodology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2019to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- midwives in their 1st year of training and who wish to participate and sign the informed consent document.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Female Pelvic Floor Interactive Training Model: RCT
Residents increase their knowledge of female pelvis anatomy using a pelvic floor interactive model methodology (Pelvic+) compared to the traditional methodology.
Read the 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
- Being tested
- Anatomy class with Pelvic+ methodology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomy class with Pelvic+ methodologyOther
Teaching of female pelvis anatomy using a interactive training model (Pelvic+ methodology)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Anatomy class with Pelvic+ methodology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- bone structure and obstetrical landmarks
- ligament structure
- superficial perineal muscle
- deep pelvis muscle
- 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.
Measured: 15 months
Secondary outcomes (1)
Satisfaction with Pelvic+ methodology compared to traditional methodology
Satisfaction with methodology: a likert-scale survey. This will consist of 12 questions with four-point agreement scale (symmetric agree-disagree scale) to measure participants agreement with a variety of statements related to the methodology of the anatomy session: theory, supporting material and time.
All participants will be assessed to complete satisfaction questionnaire at the end of the intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start25 Nov 2019
- Primary completion1 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Pereda, Universitat Autonoma de Barcelona
- Investigators
- Ana Pereda, Dr, Principal investigator, IES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153500
- Sponsor's protocol ID
- CEEAH 4764
- Status last verified
- Apr 2021
- First submitted
- 4 Oct 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Female Pelvic Floor Interactive Training Model: RCT
- ClinicalTrials.gov ID
- NCT04153500
- Acronym / sponsor ID
- CEEAH 4764
- Conditions
- Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Anatomy class with Pelvic+ methodologyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- midwives in their 1st year of training and who wish to participate and sign the informed consent document.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomy class with Pelvic+ methodologyTeaching of female pelvis anatomy using a interactive training model (Pelvic+ methodology) | Other | Pelvic+ method |
Primary outcome
Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology
Time frame: 15 months
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.
1 secondary outcome
Satisfaction with Pelvic+ methodology compared to traditional methodology
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Pereda, Dr principal investigator
IES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomy class with Pelvic+ methodology in people with Pelvic Floor, run by Universitat Autonoma de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of the female pelvis anatomy at 3 months post-intervention with Pelvic+ methodology compared to traditional methodology (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.