Learning DisabilitiesNCT04365894
Affective Learning in Disabled Health Training
A study testing Transformative learning theory in people with Learning Disabilities, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Disabilities
- What is being tested?
- Transformative learning theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 30 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years old or above,
- to study in the second year,
- taking the theoretical course of Disabled Health
Who cannot join
- having attended any training for disabled people before
- to have any disabled person in the family members with whom they live.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affective Learning in Disabled Health Training of Turkish Nursing Students: A Randomized Controlled Study
This study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students.
Read the detailed description
This randomized, controlled and experimental study was conducted between October and December 2019. The sample of the study consisted of 70 2nd grade nursing students (34 people in the experimental group and 36 in the control group). The learning method based on transformative learning theory was applied to the experimental group. The data were collected using a demographic information form, the Empathic Tendency Scale, Attitudes Towards Disabled Person Scale, and Toronto Alexithymia Scale. The Mann-Whitney U Test, Wilcoxon Signed Ranks Test, Paired Sample Test, and Pearson's Chi-Squared Test were used to determine the differences between the groups.
- Conditions
- Learning Disabilities
- Being tested
- Transformative learning theory
- Keywords
- nursing students, transformative learning, disabled
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transformative learning theoryOther
According to the transformative learning theory, learning methods in education should include four activities as investigate, collaborative, higher-order thinking and interactive learning activities
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The study was applied in 2nd grade nursing students' disability health course. The control group was taught with the traditional method. |
| Intervention | Experimental | The intervention group with learning activities based on the transformative learning theory. Receives: Other: Transformative learning theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
empathetic tendency
Empathetic tendency was evaluated Empathic Tendency Scale (ETS). ETS developed by Dökmen, aims to measure the potential of people to empathize in daily life. It is a five-point Likert-type scale consisting of 20 items. The responses on this scale range from "completely contradictory" to "completely eligible". While collecting points, questions 3, 6, 7, 8, 11, 12, 13, 15 are collected in reverse. The minimum score to be taken from the scale is 20, and the maximum is 100. The total scores refer to the participants' empathic tendency scores. High scores indicate high empathic tendency; low scores indicate that low empathic tendency. In the study where the scale was developed, the reliability coefficient was found to be .91.
Measured: Change from baseline empathetic tendency skill at 12 weeks
attitude
Attitude was evaluated Attitudes Towards Disabled Person Scale (ATDPS). ATDPS was developed by Yuker and Block and adapted to Turkish by Özyürek. The aim of the scale is to measure attitudes towards people who are affected by inadequacy in general, without specifically distinguishing disability groups. This 6-point Likert-type scale consists of 20 items, which are graded as follows: "I totally agree (+3), I agree (+2), I somewhat agree (+1), I somewhat disagree (-1), I disagree (-2), I strongly disagree (-3)". Items 2, 5, 6, 11 and 12 are inverted. The sum of the points of all items is calculated, and the sign of the total score of the scale is reversed, and 60 is added to the obtained score. As a result of this calculation, the scores that can be obtained from the scale vary between 0 and 120. High scores express positive attitudes towards individuals with disabilities, and low scores mean negative attitudes.
Measured: Change from baseline attitude skill at 12 weeks
alexithymia
Alexithymia was evaluated Toronto Alexithymia Scale (TAS). This is a 20-question scale developed by Bagby et al. TAS-20 Turkish validity and reliability analyzes were performed by Gulec et al. The scale is a 5-point Likert-type measurement tool, and individuals are asked to mark the most appropriate options among "Never", "Rarely", "Sometimes", "Often" and "Always". Three sub-dimensions of the scale are difficulty identifying feelings (7 items), difficulty describing feelings (5 items) and externally oriented thinking (8 items). The reliability coefficients of the subscales are 0.82, 0.75 and 0.72, respectively. The scoring is done by summing up the points of the items. Five of these items (items 4, 5, 10, 18 and 19) are reversed. The lowest score that can be obtained from the scale is 20, and the highest score is 100. High scores indicate high alexithymia levels.
Measured: Change from baseline Alexithymia skill at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Learning DisabilitiesStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Berna Dinçer, PhD, Principal investigator, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365894
- Sponsor's protocol ID
- 121234
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsimane TA, Downing C. Transformative learning in nursing education: A concept analysis. Int J Nurs Sci. 2019 Dec 16;7(1):91-98. doi: 10.1016/j.ijnss.2019.12.006. eCollection 2020 Jan 10.
PubMed 32099865Geckil E, Kaleci E, Cingil D, Hisar F. The effect of disability empathy activity on the attitude of nursing students towards disabled people: a pilot study. Contemp Nurse. 2017 Feb;53(1):82-93. doi: 10.1080/10376178.2017.1292143. Epub 2017 Mar 2.
PubMed 28277092Seccombe JA. Attitudes towards disability in an undergraduate nursing curriculum: a literature review. Nurse Educ Today. 2007 Jul;27(5):459-65. doi: 10.1016/j.nedt.2006.08.005. Epub 2006 Oct 9.
PubMed 17030492
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Learning in Disabled Health Training of Turkish Nursing Students: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04365894
- Acronym / sponsor ID
- 121234
- Conditions
- Learning Disabilities
- Keywords
- nursing students, transformative learning, disabled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 Apr 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.
This study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students.
Detailed description
This randomized, controlled and experimental study was conducted between October and December 2019. The sample of the study consisted of 70 2nd grade nursing students (34 people in the experimental group and 36 in the control group). The learning method based on transformative learning theory was applied to the experimental group. The data were collected using a demographic information form, the Empathic Tendency Scale, Attitudes Towards Disabled Person Scale, and Toronto Alexithymia Scale. The Mann-Whitney U Test, Wilcoxon Signed Ranks Test, Paired Sample Test, and Pearson's Chi-Squared Test were used to determine the differences between the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The study was applied in 2nd grade nursing students' disability health course. The control group was taught with the traditional method. |
| Intervention | Experimental | Other: Transformative learning theoryThe intervention group with learning activities based on the transformative learning theory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being 18 years old or above,
- to study in the second year,
- taking the theoretical course of Disabled Health
Key exclusion criteria (2 listed)
- having attended any training for disabled people before
- to have any disabled person in the family members with whom they live.
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 |
|---|---|---|
| Transformative learning theoryAccording to the transformative learning theory, learning methods in education should include four activities as investigate, collaborative, higher-order thinking and interactive learning activities | Other | Intervention |
Primary outcome
empathetic tendency
Time frame: Change from baseline empathetic tendency skill at 12 weeks
Empathetic tendency was evaluated Empathic Tendency Scale (ETS). ETS developed by Dökmen, aims to measure the potential of people to empathize in daily life. It is a five-point Likert-type scale consisting of 20 items. The responses on this scale range from "completely contradictory" to "completely eligible". While collecting points, questions 3, 6, 7, 8, 11, 12, 13, 15 are collected in reverse. The minimum score to be taken from the scale is 20, and the maximum is 100. The total scores refer to the participants' empathic tendency scores. High scores indicate high empathic tendency; low scores indicate that low empathic tendency. In the study where the scale was developed, the reliability coefficient was found to be .91.
attitude
Time frame: Change from baseline attitude skill at 12 weeks
Attitude was evaluated Attitudes Towards Disabled Person Scale (ATDPS). ATDPS was developed by Yuker and Block and adapted to Turkish by Özyürek. The aim of the scale is to measure attitudes towards people who are affected by inadequacy in general, without specifically distinguishing disability groups. This 6-point Likert-type scale consists of 20 items, which are graded as follows: "I totally agree (+3), I agree (+2), I somewhat agree (+1), I somewhat disagree (-1), I disagree (-2), I strongly disagree (-3)". Items 2, 5, 6, 11 and 12 are inverted. The sum of the points of all items is calculated, and the sign of the total score of the scale is reversed, and 60 is added to the obtained score. As a result of this calculation, the scores that can be obtained from the scale vary between 0 and 120. High scores express positive attitudes towards individuals with disabilities, and low scores mean negative attitudes.
alexithymia
Time frame: Change from baseline Alexithymia skill at 12 weeks
Alexithymia was evaluated Toronto Alexithymia Scale (TAS). This is a 20-question scale developed by Bagby et al. TAS-20 Turkish validity and reliability analyzes were performed by Gulec et al. The scale is a 5-point Likert-type measurement tool, and individuals are asked to mark the most appropriate options among "Never", "Rarely", "Sometimes", "Often" and "Always". Three sub-dimensions of the scale are difficulty identifying feelings (7 items), difficulty describing feelings (5 items) and externally oriented thinking (8 items). The reliability coefficients of the subscales are 0.82, 0.75 and 0.72, respectively. The scoring is done by summing up the points of the items. Five of these items (items 4, 5, 10, 18 and 19) are reversed. The lowest score that can be obtained from the scale is 20, and the highest score is 100. High scores indicate high alexithymia levels.
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 29 Apr 2020.
- Background: PubMed 32099865Tsimane TA, Downing C. Transformative learning in nursing education: A concept analysis. Int J Nurs Sci. 2019 Dec 16;7(1):91-98. doi: 10.1016/j.ijnss.2019.12.006. eCollection 2020 Jan 10.
- Background: PubMed 28277092Geckil E, Kaleci E, Cingil D, Hisar F. The effect of disability empathy activity on the attitude of nursing students towards disabled people: a pilot study. Contemp Nurse. 2017 Feb;53(1):82-93. doi: 10.1080/10376178.2017.1292143. Epub 2017 Mar 2.
- Background: PubMed 17030492Seccombe JA. Attitudes towards disability in an undergraduate nursing curriculum: a literature review. Nurse Educ Today. 2007 Jul;27(5):459-65. doi: 10.1016/j.nedt.2006.08.005. Epub 2006 Oct 9.
- 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.
Berna Dinçer, PhD principal investigator
İstanbul Medeniyet 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 Transformative learning theory in people with Learning Disabilities, run by Istanbul Saglik Bilimleri 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 29 Apr 2020. 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?
empathetic tendency (time frame: Change from baseline empathetic tendency skill at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365894, which also lists 3 linked publications.
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 29 Apr 2020.