EmpathyNCT05731921
Effect of 'Empathy Dress' and Exercise on Midwifery Students' Discomfort, Empathy and Compassionate Love Levels
A study testing The exercise program with the 'Empathy Dress' in people with Empathy and Discomfort, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student are planned to be included in the study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Empathy, Discomfort, Love
- What is being tested?
- The exercise program with the 'Empathy Dress'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 1 Feb 2024
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Absence of a defined psychiatric disorder
- There is no problem that prevents communication
Who cannot join
- Those who have movement system problems that prevent them from exercising with increasing weights by adapting to their pregnancy weeks,
- Individuals who do not meet the inclusion criteria or who do not volunteer to participate in the research despite meeting them will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of the Exercise Program With the 'Empathy Dress' Applied to Midwifery Students on the Levels of Physical Discomfort, Empathy and Compassionate Love: A Randomized Controlled Study
To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student are planned to be included in the study. Data will be collected with the "Student Information Form", "The Toronto Empathy Questionnaire- TEQ", "Evaluation Scale for Physical Discomfort", and "The Compassionate Love Scale". In the study, an exercise program that includes a total of eight sessions of 'Empathy Dress' and some exercises, every week and 20 minutes per week to the midwifery students in the experimental group, by the researcher. It is thought that the results of the study will improve the empathy and sensitive love levels of midwifery students and increase the quality of midwifery care offered.
Read the detailed description
Midwifery education consists of two parts, theoretical and clinical, which complement each other. Educators in the field of midwifery should strengthen students' skills before going to the clinic by following innovative training techniques. In this context, it is recommended that the simulation supported midwifery education model be used, disseminated and included in the curriculum of midwifery departments, as it contributes to students.To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student (31 experimental, 31 control) are planned to be included in the study. Data will be collected with the "Student Information Form", "The Toronto Empathy Questionnaire- TEQ", "Evaluation Scale for Physical Discomfort", and "The Compassionate Love Scale". In the study, an exercise program that includes a total of eight sessions (two months) of 'Empathy Dress' and some exercises (stairs going up and down, sitting up, putting on trousers, tying shoes, etc.), every week and 20 minutes per week to the midwifery students in the experimental group, by the researcher. The expected result of the study is to determine whether the exercise program with the 'Empathy Dress' is an effective intervention in increasing the empathy and compassionate love levels in midwifery students. In addition, the effect of the 'Empathy Dress' and exercise program on the physical discomfort levels of midwifery students is investigated. It is thought that the results of the study will improve the empathy and sensitive love levels of midwifery students and increase the quality of midwifery care offered.
- Conditions
- Empathy, Discomfort, Love
- Being tested
- The exercise program with the 'Empathy Dress'
- Keywords
- Midwifery, Student, Empathy level, Physical discomfort level, Compassionate Love level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise program with the 'Empathy Dress'Behavioural
The experimental group will be given an exercise program that includes a total of eight sessions (two months) of 'Empathy Dress' and some exercises (stairs going up and down, sitting up, putting on trousers, tying shoes, etc.), every week and 20 minutes per week, by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The exercise program with the 'Empathy Dress' Receives: Behavioral: The exercise program with the 'Empathy Dress' |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathy Level
Empathy is one of the primary outcomes. This will be measured using 'The Toronto Empathy Questionnaire- TEQ'. The minimum score that can be obtained from the scale is "13", the maximum score is "65", and as the score obtained from the scale increases, empathy levels also increase.
Measured: 2 months
Compassionate Love Level
Compassionate Love Level is the other primary outcomes. This will be measured using 'The Compassionate Love Scale'. The minimum score that can be obtained from the scale is "21", the maximum score is "147", and as the score obtained from the scale increases, Compassionate Love levels also increase.
Measured: 2 months
Secondary outcomes (1)
Physical Discomfort Level
Physical Discomfort Level is the other primary outcomes. This will be measured using 'Evaluation Scale for Physical Discomfort'. This form was developed by the researchers and consists of 4 items. The score ranges from 0 to 10 points, with increasing score reflecting more discomfort.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Feb 2023
- Primary completion30 Apr 2023
- Study completion1 Feb 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with pretest-posttest control group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Akca, Amasya University
- Investigators
- Emine İbici Akça, Ph.D, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731921
- Sponsor's protocol ID
- Amasya Univ
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2023
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of the Exercise Program With the 'Empathy Dress' Applied to Midwifery Students on the Levels of Physical Discomfort, Empathy and Compassionate Love: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05731921
- Acronym / sponsor ID
- Amasya Univ
- Conditions
- Empathy, Discomfort, Love
- Keywords
- Midwifery, Student, Empathy level, Physical discomfort level, Compassionate Love level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 16 Feb 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.
To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student are planned to be included in the study. Data will be collected with the "Student Information Form", "The Toronto Empathy Questionnaire- TEQ", "Evaluation Scale for Physical Discomfort", and "The Compassionate Love Scale". In the study, an exercise program that includes a total of eight sessions of 'Empathy Dress' and some exercises, every week and 20 minutes per week to the midwifery students in the experimental group, by the researcher. It is thought that the results of the study will improve the empathy and sensitive love levels of midwifery students and increase the quality of midwifery care offered.
Detailed description
Midwifery education consists of two parts, theoretical and clinical, which complement each other. Educators in the field of midwifery should strengthen students' skills before going to the clinic by following innovative training techniques. In this context, it is recommended that the simulation supported midwifery education model be used, disseminated and included in the curriculum of midwifery departments, as it contributes to students.To investigate the effect of the exercise program with the 'Empathy Dress' applied to midwifery students on the Levels of physical discomfort, empathy and compassionate love in the midwifery department of Amasya University. A total of 62 midwifery student (31 experimental, 31 control) are planned to be included in the study. Data will be collected with the "Student Information Form", "The Toronto Empathy Questionnaire- TEQ", "Evaluation Scale for Physical Discomfort", and "The Compassionate Love Scale". In the study, an exercise program that includes a total of eight sessions (two months) of 'Empathy Dress' and some exercises (stairs going up and down, sitting up, putting on trousers, tying shoes, etc.), every week and 20 minutes per week to the midwifery students in the experimental group, by the researcher. The expected result of the study is to determine whether the exercise program with the 'Empathy Dress' is an effective intervention in increasing the empathy and compassionate love levels in midwifery students. In addition, the effect of the 'Empathy Dress' and exercise program on the physical discomfort levels of midwifery students is investigated. It is thought that the results of the study will improve the empathy and sensitive love levels of midwifery students and increase the quality of midwifery care offered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial with pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: The exercise program with the 'Empathy Dress'The exercise program with the 'Empathy Dress' |
| Control group | No intervention | –No intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Absence of a defined psychiatric disorder
- There is no problem that prevents communication
Key exclusion criteria (2 listed)
- Those who have movement system problems that prevent them from exercising with increasing weights by adapting to their pregnancy weeks,
- Individuals who do not meet the inclusion criteria or who do not volunteer to participate in the research despite meeting them will be excluded from 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 |
|---|---|---|
| The exercise program with the 'Empathy Dress'The experimental group will be given an exercise program that includes a total of eight sessions (two months) of 'Empathy Dress' and some exercises (stairs going up and down, sitting up, putting on trousers, tying shoes, etc.), every week and 20 minutes per week, by the researchers. | Behavioural | Experimental group |
Primary outcome
Empathy Level
Time frame: 2 months
Empathy is one of the primary outcomes. This will be measured using 'The Toronto Empathy Questionnaire- TEQ'. The minimum score that can be obtained from the scale is "13", the maximum score is "65", and as the score obtained from the scale increases, empathy levels also increase.
Compassionate Love Level
Time frame: 2 months
Compassionate Love Level is the other primary outcomes. This will be measured using 'The Compassionate Love Scale'. The minimum score that can be obtained from the scale is "21", the maximum score is "147", and as the score obtained from the scale increases, Compassionate Love levels also increase.
1 secondary outcome
Physical Discomfort Level
Time frame: 2 months
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 22 Apr 2024.
- 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.
Emine İbici Akça, Ph.D principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The exercise program with the 'Empathy Dress' in people with Empathy and Discomfort, run by Amasya 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 3 inclusion and 2 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 22 Apr 2024. 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?
Empathy Level (time frame: 2 months). 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 22 Apr 2024.