Clinical InterviewNCT05866601
Effects on Anxiety in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview
An observational study of Clinical Interview, run by Mayuben Private Clinic at 2 sites in Spain.
Trial summary
The aim of the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Clinical Interview
- What is being tested?
- Role-playing for learning the clinical interview
- How many people
- 28 participants
- Where
- 2 sitesSpain
- Study dates
- 23 May 2023to 2 Jun 2023
- Phase
- Observational
- 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 100 years
- All sexes
- Adult, Older adult
Study population: First year physiotherapy students who carry out the role playing of the clinical history.
Who may be able to join
- Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.
Who cannot join
- Students who do not wish to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Eva María Martínez-Jiménez
Madrid, Madrid, 28040
Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: Effects on Anxiety in Physiotherapy Students After Simulation With Kirkpatric Evaluation as an Active Method for Learning the Clinical Enterview
The aim of the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history.
Read the detailed description
Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.
Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of anxiety.
- Conditions
- Clinical Interview
- Being tested
- Role-playing for learning the clinical interview
- Keywords
- Medical education, nursing education, physiotherapy, empathy, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role-playing for learning the clinical interviewOther
Also called Role-plaiyng
Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.
Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of empathy and anxiety.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Questionnaire called STAI before role playing
This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.
Measured: Through study completion, an average of 12 days
Anxiety Questionnaire called STAI after role playing
This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.
Measured: Through study completion, an average of 12 days
Jefferson scale before role playing
To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.
Measured: Through study completion, an average of 12 days
Jefferson scale after role playing
To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.
Measured: Through study completion, an average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start23 May 2023
- Primary completion30 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical InterviewStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866601
- Sponsor's protocol ID
- 23/293.1
- Status last verified
- Jun 2023
- First submitted
- 10 May 2023
- Last updated
- 5 Jun 2023
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Anxiety in Physiotherapy Students After Simulation With Kirkpatric Evaluation as an Active Method for Learning the Clinical Enterview
- ClinicalTrials.gov ID
- NCT05866601
- Acronym / sponsor ID
- 23/293.1
- Conditions
- Clinical Interview
- Keywords
- Medical education, nursing education, physiotherapy, empathy, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 19 May 2023 (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 the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history.
Detailed description
Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.
Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of anxiety.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- First year physiotherapy students who carry out the role playing of the clinical history.
Key inclusion criteria (1 listed)
- Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.
Key exclusion criteria (1 listed)
- Students who do not wish to participate in the study.
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 |
|---|---|---|
| Role-playing for learning the clinical interviewAlso: Role-plaiyngThirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy. Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of empathy and anxiety. | Other | – |
Primary outcome
Anxiety Questionnaire called STAI before role playing
Time frame: Through study completion, an average of 12 days
This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.
Anxiety Questionnaire called STAI after role playing
Time frame: Through study completion, an average of 12 days
This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.
Jefferson scale before role playing
Time frame: Through study completion, an average of 12 days
To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.
Jefferson scale after role playing
Time frame: Through study completion, an average of 12 days
To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.
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 5 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Clinical Interview
RecruitingObservational study
Developing a Methodological Framework and a Dissemination Plan for Herb-drug Interactions-related Clinical Practice Guidelines
Herb-drug Interactions
Not yet recruitingObservational study
AI-CLINIC: A Prospective Multisite Feasibility and Safety Study of AI-Assisted Pre-Consultation History-Taking in Outpatient Cardiology
Symptom Tracking, Cardiology
Enrolling by invitationObservational study
Safety, Feasibility, and Acceptability of the MINERVA Voice Conversational Agent for Emergency Department History-Taking
History Taking, Artificial Intelligence (AI)
Active, not recruiting
LLM Psychiatric Intake AI Clinical Performance Study
Mental Disorders
Not yet recruitingObservational study
Augmenting Clinical Workflow With a Structured Chatbot for Patient History Collection and Diagnostic Support
Medical History Taking, Artificial Intelligence in Clinical Workflow
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Interview, run by Mayuben Private Clinic at 2 sites 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Anxiety Questionnaire called STAI before role playing (time frame: Through study completion, an average of 12 days). The study lists 4 primary outcomes in all. 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 5 Jun 2023.