Effects on Anxiety in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview

June 2, 2023 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid
    • Madrid
      • Madrid., Madrid, Spain, 28040
        • Eva María Martínez-Jiménez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

First year physiotherapy students who carry out the role playing of the clinical history.

Description

Inclusion Criteria:

  • Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Exclusion Criteria:

  • Students who do not wish to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 12 days
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.
Through study completion, an average of 12 days
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.
Through study completion, an average of 12 days
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.
Through study completion, an average of 12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayuben Private Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23/293.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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