EthicsNCT03795077
Effect of a Programme Based on Professional Ethics in Physiotherapy Students
A study testing Experimental group in people with Ethics, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students. A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Ethics
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2019to 23 Mar 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To study the physical therapy degree at the University of Valencia
Who cannot join
- Exclusion criterion was having prior training on Ethics subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Higher Education Programme Based on Professional Ethics in Physiotherapy Students
The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students.
A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out.
The investigators compared a control group (traditonal lectures) with an intervention group (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional values, and opinions towards professional ethics were evaluated before and after the programme, in both groups. All participants were informed about the study and procedures, and provided written informed consent.
Read the detailed description
Participants. Second-year degree students of Physiotherapy Degree at the University, aged between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All enrolled participants were informed of the purpose of the study and procedures, and provided written informed consent. The study was carried out at the institution where the authors belong.
Research design. A prospective simple-blind trial was performed. After baseline assessment, participants were allocated to one of the two groups (control group and experimental group). An external assistant not involved in the study performed assignment.
Intervention. A Physiotherapy professor with over-10-year experience in Ethics and Physiotherapy performed the teaching methodology and opened the allocation envelopes and applied the teaching methodology to the EG according to the group assignment. The intervention consisted of a three-month program based in professional ethics, including two phases: A) syllabus and activities; and B) face to face group sessions including techniques such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.
- Conditions
- Ethics
- Being tested
- Experimental group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Experimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group followed traditional lectures about professional ethics during 3 months as usual. |
| Experimental group | Experimental | Experimental group followed the programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used. Techniques used: concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups. Receives: Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Professional Ethicss
measured with an ad-hoc retention test. The students were not previously informed about retention exams to avoid any preparation for the test. The tests included 15 multiple choice questions that assessed basic professional ethics concepts that physiotherapy students are required to know, such as: moral values, bioethics and Professional Ethics in physiotherapy, professional ethical principles, physiotherapists deontological code, ethical situations, or professional values in physiotherapy.
Measured: 12 weeks
Secondary outcomes (3)
Perception of knowledge regarding professional Ethics
A self-reported questionnaire of 19 items (the Perceptions about Knowledge regarding Professional Ethics in Physiotherapy, PKPEPT, Cronbach's alpha=0.760) was previously described.27,28 The higher score indicated the best perception of knowlegde. The questionnaires' items included basic professional ethics concepts that physiotherapy students are required to know. Therefore, questions assessed participants' perception about knowledge regarding basic concepts in Professional Ethics and their application in physiotherapy care. Items were created in order to be important and to be clearly related with perception of knowledge.
Measured: 12 weeks
Quality assessment
It was assessed for both groups by the Teaching evaluation of the Center for Quality of the University of Valencia. This center offers the students online surveys with different items evaluating the teaching methodologies, materials and general satisfaction by a Likert scale (1 totally disagree to 5 totally agree) in undergraduate degree, through the Virtual Office of the University.
Measured: 12 weeks
Satisfaction assessment
For the Cooperative Learning group, an ad-hoc satisfaction questionnaire was carried out, using the Kahoot application. The satisfaction questionnaire included 16 questions in total: 5 dichotomous questions about opinion about the methodology, 5 dichotomous questions about the themes; 3 Likert-type questions (not at all / little / quite / a lot) about interest and usefulness of the content / contents, and 3 questions about satisfaction, usefulness and fun with respect to the techniques used, Likert-type: from 0 to 5 points. This evaluation was only carried out at the end of the program.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start2 Jan 2019
- Primary completion30 Apr 2019
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EthicsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Marques-Sule, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795077
- Sponsor's protocol ID
- 545879652
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2019
- Last updated
- 8 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Higher Education Programme Based on Professional Ethics in Physiotherapy Students
- ClinicalTrials.gov ID
- NCT03795077
- Acronym / sponsor ID
- 545879652
- Conditions
- Ethics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 7 Jan 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.
The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students.
A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out.
The investigators compared a control group (traditonal lectures) with an intervention group (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional values, and opinions towards professional ethics were evaluated before and after the programme, in both groups. All participants were informed about the study and procedures, and provided written informed consent.
Detailed description
Participants. Second-year degree students of Physiotherapy Degree at the University, aged between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All enrolled participants were informed of the purpose of the study and procedures, and provided written informed consent. The study was carried out at the institution where the authors belong.
Research design. A prospective simple-blind trial was performed. After baseline assessment, participants were allocated to one of the two groups (control group and experimental group). An external assistant not involved in the study performed assignment.
Intervention. A Physiotherapy professor with over-10-year experience in Ethics and Physiotherapy performed the teaching methodology and opened the allocation envelopes and applied the teaching methodology to the EG according to the group assignment. The intervention consisted of a three-month program based in professional ethics, including two phases: A) syllabus and activities; and B) face to face group sessions including techniques such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group followed traditional lectures about professional ethics during 3 months as usual. |
| Experimental group | Experimental | Other: Experimental groupExperimental group followed the programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used. Techniques used: concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To study the physical therapy degree at the University of Valencia
Key exclusion criteria (1 listed)
- Exclusion criterion was having prior training on Ethics subject
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 |
|---|---|---|
| Experimental groupExperimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used. | Other | Experimental group |
Primary outcome
Knowledge of Professional Ethicss
Time frame: 12 weeks
measured with an ad-hoc retention test. The students were not previously informed about retention exams to avoid any preparation for the test. The tests included 15 multiple choice questions that assessed basic professional ethics concepts that physiotherapy students are required to know, such as: moral values, bioethics and Professional Ethics in physiotherapy, professional ethical principles, physiotherapists deontological code, ethical situations, or professional values in physiotherapy.
3 secondary outcomes
Perception of knowledge regarding professional Ethics
Time frame: 12 weeks
Quality assessment
Time frame: 12 weeks
Satisfaction assessment
Time frame: 12 weeks
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 8 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Ethics, run by University of Valencia 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 1 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 8 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 Professional Ethicss (time frame: 12 weeks). 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 8 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.