EmpathyNCT04603534
Aged Simulation Suit Among Physiotherapy Students
A study testing Aged Simulation Suit in people with Empathy and Attitude, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Turkey is the second fastest aging country in the world. According to the Turkey Statistical Institute's data, the distribution of the population aged 65 and over is expected to be 25.6% in 2080. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- What is being tested?
- Aged Simulation Suit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2010to 18 Dec 2020
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being volunteer to participate
Who cannot join
- Having an advanced visual and balance problems especially associated with inner ear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empathy and Attitude Upon An Aged Body: Aged Simulation Suit Among Undergraduate Physiotherapy Students
Turkey is the second fastest aging country in the world. According to the Turkey Statistical Institute's data, the distribution of the population aged 65 and over is expected to be 25.6% in 2080. Today, studies have been started to determine the empathy and attitudes of the young generation, especially the younger generation, towards older individuals and to develop them. In this context, it is thought that the simulation designed to simulate the aging process of human beings may have a positive effect on students' understanding of aging and perception of aging. In this study, the effect of aged simulation suit on empathy and attitudes towards elderly people will be determined in Physiotherapy and Rehabilitation undergraduate students.
Read the detailed description
Attitude is defined as a positive or negative assessment of people, objects or events that reflect one's knowledge, emotions, and behavior towards people, objects or events. Physical degeneration in the elderly can easily lead to prejudice or discrimination against older adults, especially in the younger generation. The younger generation sees older adults as a different group and labels them with negative traits. However, education has an important role in changing attitudes towards older people and developing professional cultures. In this context, the positive attitudes and behaviors of healthcare professionals (doctors, nurses, physiotherapists, etc.) starting from the pre-graduation period are of great importance for quality health services.
Empathy, which consists of emotional, cognitive, operational, and physiological behavior and reaction compounds, was mostly evaluated as a process of relationships and attitudes. Healthcare providers should be able to grasp patients' perspectives (cognitive empathy) and relate to their emotions and experiences (emotional empathy). It can be difficult to understand other people's perspectives, especially if they have not experienced disability due to aging or disease. It has been reported in the literature that health professionals lack empathy and understanding towards older individuals. It has been suggested that empathy in patient care can be developed at a basic level and through vocational education. Defining the attitudes of healthcare professionals and students and implementing new educational strategies that encourage positive attitudes towards the elderly while they are still students are important for increasing the quality of healthcare offered to the elderly and developing a positive attitude.
In medical and health sciences undergraduate education, there has been a lack of specific lessons on which directly focuses empathy, yet simulation-based modalities have been shown to be impacted on students' perceptions regarding attitude and empathy.
Thus, this study aims to assess the attitude and empathy level toward on elderly people among health sciences undergraduate students. The intervention which is mainly based upon wearing an aged simulation suit through some activities related to independent living and mobility has been planned to performed.
- Being tested
- Aged Simulation Suit
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Simulation SuitOther
The aged simulation suit (Sakamoto Model M716, Tokyo, Japan) will be worn by students. The simulation suit consist of a several items such as loads, a soft material band with Velcro, glasses, ear plugs, gloves, belts and a cane. All the items are need to simulate one's posture just like in elderly person. Small, medium and large sizes of suits are provided by the company thereby each suit is suitable for each student related to their wearing size. Prior to this study, a total of three sets of suits will be gathered. Then, each student will perform each pre-defined scenarios step by step after the suit is worn. During the activities no help or leading will be given to the students. However, one of the researchers will supervise the students during the activities so that to integrate a safe platform. In addition, each student will be informed that if he/she can terminate the activity whenever it is required.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Aged Simulation Suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline The Jefferson Scale of Empathy Health Professions Students immediately after the intervention
The Jefferson Scale of Empathy Health Professions Students (JSE-HPS) was originally developed by Jefferson University intended to measure empathy levels for health professionals. The JSE-HPS consists of a total 20-items each scored by seven point Likert Scale as 1: "Strongly disagree" through 7: "Strongly agree". 10 out of 20 items are scored directly according to the Likert weights while the other half are reversely scored. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.
Measured: At baseline and immediately after the intervention
Change from Baseline Kogan's Attitude towards Old People scale immediately after the intervention
The scale consists a total of 34 items which was originally developed by Kogan et al. The same as in JSE-HPS, seventeen items which are directly scored as Likert weights according to the 6 point Likert scale in which 1: "Strongly Disagree" through 6: "Strongly agree" while the rest of seventeen items are scored reversely. The minimum and maximum points of Kogan's Attitude towards Old People (KAOP) scale can be 34 and 238. The interpretation of score of KAOP scale is linear in which higher scores indicate a more positive attitude while lower scores indicate the worse. Reliability of the total KAOP scale were found in different studies as 0.87 and 0.89.
Measured: At baseline and immediately after the intervention
Secondary outcomes (1)
Semi-structure Interview
Experiences and emotions regarding the aged simulation suit will be collected from the students by asking reflective questions for each student one by one. Qualitative discussion will be made by taking experiences and perceptions of students upon the aged simulation suit.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start15 Mar 2010
- Primary completion25 Nov 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603534
- Sponsor's protocol ID
- 2020/14
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy and Attitude Upon An Aged Body: Aged Simulation Suit Among Undergraduate Physiotherapy Students
- ClinicalTrials.gov ID
- NCT04603534
- Acronym / sponsor ID
- 2020/14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 15 Mar 2010 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 27 Oct 2020 (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.
Turkey is the second fastest aging country in the world. According to the Turkey Statistical Institute's data, the distribution of the population aged 65 and over is expected to be 25.6% in 2080. Today, studies have been started to determine the empathy and attitudes of the young generation, especially the younger generation, towards older individuals and to develop them. In this context, it is thought that the simulation designed to simulate the aging process of human beings may have a positive effect on students' understanding of aging and perception of aging. In this study, the effect of aged simulation suit on empathy and attitudes towards elderly people will be determined in Physiotherapy and Rehabilitation undergraduate students.
Detailed description
Attitude is defined as a positive or negative assessment of people, objects or events that reflect one's knowledge, emotions, and behavior towards people, objects or events. Physical degeneration in the elderly can easily lead to prejudice or discrimination against older adults, especially in the younger generation. The younger generation sees older adults as a different group and labels them with negative traits. However, education has an important role in changing attitudes towards older people and developing professional cultures. In this context, the positive attitudes and behaviors of healthcare professionals (doctors, nurses, physiotherapists, etc.) starting from the pre-graduation period are of great importance for quality health services.
Empathy, which consists of emotional, cognitive, operational, and physiological behavior and reaction compounds, was mostly evaluated as a process of relationships and attitudes. Healthcare providers should be able to grasp patients' perspectives (cognitive empathy) and relate to their emotions and experiences (emotional empathy). It can be difficult to understand other people's perspectives, especially if they have not experienced disability due to aging or disease. It has been reported in the literature that health professionals lack empathy and understanding towards older individuals. It has been suggested that empathy in patient care can be developed at a basic level and through vocational education. Defining the attitudes of healthcare professionals and students and implementing new educational strategies that encourage positive attitudes towards the elderly while they are still students are important for increasing the quality of healthcare offered to the elderly and developing a positive attitude.
In medical and health sciences undergraduate education, there has been a lack of specific lessons on which directly focuses empathy, yet simulation-based modalities have been shown to be impacted on students' perceptions regarding attitude and empathy.
Thus, this study aims to assess the attitude and empathy level toward on elderly people among health sciences undergraduate students. The intervention which is mainly based upon wearing an aged simulation suit through some activities related to independent living and mobility has been planned to performed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Aged Simulation Suit |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being volunteer to participate
Key exclusion criteria (1 listed)
- Having an advanced visual and balance problems especially associated with inner ear
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 |
|---|---|---|
| Aged Simulation SuitThe aged simulation suit (Sakamoto Model M716, Tokyo, Japan) will be worn by students. The simulation suit consist of a several items such as loads, a soft material band with Velcro, glasses, ear plugs, gloves, belts and a cane. All the items are need to simulate one's posture just like in elderly person. Small, medium and large sizes of suits are provided by the company thereby each suit is suitable for each student related to their wearing size. Prior to this study, a total of three sets of suits will be gathered. Then, each student will perform each pre-defined scenarios step by step after the suit is worn. During the activities no help or leading will be given to the students. However, one of the researchers will supervise the students during the activities so that to integrate a safe platform. In addition, each student will be informed that if he/she can terminate the activity whenever it is required. | Other | Intervention group |
Primary outcome
Change from Baseline The Jefferson Scale of Empathy Health Professions Students immediately after the intervention
Time frame: At baseline and immediately after the intervention
The Jefferson Scale of Empathy Health Professions Students (JSE-HPS) was originally developed by Jefferson University intended to measure empathy levels for health professionals. The JSE-HPS consists of a total 20-items each scored by seven point Likert Scale as 1: "Strongly disagree" through 7: "Strongly agree". 10 out of 20 items are scored directly according to the Likert weights while the other half are reversely scored. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.
Change from Baseline Kogan's Attitude towards Old People scale immediately after the intervention
Time frame: At baseline and immediately after the intervention
The scale consists a total of 34 items which was originally developed by Kogan et al. The same as in JSE-HPS, seventeen items which are directly scored as Likert weights according to the 6 point Likert scale in which 1: "Strongly Disagree" through 6: "Strongly agree" while the rest of seventeen items are scored reversely. The minimum and maximum points of Kogan's Attitude towards Old People (KAOP) scale can be 34 and 238. The interpretation of score of KAOP scale is linear in which higher scores indicate a more positive attitude while lower scores indicate the worse. Reliability of the total KAOP scale were found in different studies as 0.87 and 0.89.
1 secondary outcome
Semi-structure Interview
Time frame: Immediately after the intervention
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 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 Aged Simulation Suit in people with Empathy and Attitude, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 26 Apr 2022. 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 Turkey (Türkiye). 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?
Change from Baseline The Jefferson Scale of Empathy Health Professions Students immediately after the intervention (time frame: At baseline and immediately after the intervention). The study lists 2 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 26 Apr 2022.