Nursing EducationNCT06418815
Concept Map on Toxic Stress in Newborns
A study testing Concept map group in people with Nursing Education and Newborn, run by Çankırı Karatekin University.
Trial summary
This study will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students. Read more about this study
- Who is it for?
- Ages 19 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Newborn
- What is being tested?
- Concept map group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2024to 6 Jun 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 19 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled in the course
- Had not taken this course before
- Accepted to participate in the research
Who cannot join
- Have any records of absence
- Taken this course before
- Graduate of health vocational high school
About this study
Official title: Effect of Concept Map on Nursing Students' Ability to Assess Toxic Stress in Newborns: A Randomized Controlled Trial
This study will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students.
Read the detailed description
The Newborn Toxic Stress Knowledge Test (1st Test) will be administered to intervention and control group students who agree to participate in the research, before the 4-hour High Risk Newborn theoretical lecture. Training on Toxic Stress in Newborns will be given to both groups, and then a post-training knowledge test (2nd Test) will be administered. The initiative group will be composed of students who apply concept maps and make in-class maintenance plans after theoretical training. The control group will consist of students who receive theoretical training and implement in-class care plans. After the concept map application, a knowledge test will be applied again (3rd Test).
The data of the research will be collected with the Personal Information Form and Newborn Toxic Stress Information Test.
The personal information form was prepared by the researchers. In shape; There are questions about the student's age, gender, secondary school graduation status, whether they choose the nursing profession willingly, whether they consider the nursing profession suitable for themselves, whether they have heard the term concept map and whether they have applied concept map.
Newborn Toxic Stress Information Test was prepared by researchers. The test consists of 25 multiple choice questions. It consists of true, false and I don't know options.
- Conditions
- Nursing Education, Newborn
- Being tested
- Concept map group
- Keywords
- Concept map, Nursing education, Toxic stress, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concept map groupOther
The intervention group will create a concept map regarding neonatal toxic stress.
| Study group | Role | What they receive |
|---|---|---|
| Concept Map Group | Experimental | The intervention group will create a concept map regarding neonatal toxic stress. Receives: Other: Concept map group |
| Control Group | No intervention | During the application process of the research, knowledge tests will be applied as pre-test and post-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of knowledge scores between groups
First, second and thirth knowledge tests will be applied to measure the level of knowledge. The student can get a minimum of 0 and a maximum of 100 from the knowledge test. Higher scores mean better results.
Measured: The first knowledge test (pre-test) will be given before class in the first week. Two knowledge tests will be administered for the final test. Total duration is 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start6 May 2024 (estimated)
- Primary completion13 May 2024 (estimated)
- Study completion6 Jun 2024 (estimated)
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 Nursing EducationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin PEKYİGİT, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418815
- Sponsor's protocol ID
- CKU12
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sand-Jecklin K. The impact of active/cooperative instruction on beginning nursing student learning strategy preference. Nurse Educ Today. 2007 Jul;27(5):474-80. doi: 10.1016/j.nedt.2006.08.006. Epub 2006 Oct 9.
PubMed 17030077Gul RB, Boman JA. Concept mapping: A strategy for teaching and evaluation in nursing education. Nurse Educ Pract. 2006 Jul;6(4):199-206. doi: 10.1016/j.nepr.2006.01.001. Epub 2006 Feb 28.
PubMed 19040878Baliga SS, Walvekar PR, Mahantshetti GJ. Concept map as a teaching and learning tool for medical students. J Educ Health Promot. 2021 Jan 28;10:35. doi: 10.4103/jehp.jehp_146_20. eCollection 2021.
PubMed 33688544
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concept Map on Nursing Students' Ability to Assess Toxic Stress in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06418815
- Acronym / sponsor ID
- CKU12
- Conditions
- Nursing Education, Newborn
- Keywords
- Concept map, Nursing education, Toxic stress, Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 17 May 2024 (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 will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students.
Detailed description
The Newborn Toxic Stress Knowledge Test (1st Test) will be administered to intervention and control group students who agree to participate in the research, before the 4-hour High Risk Newborn theoretical lecture. Training on Toxic Stress in Newborns will be given to both groups, and then a post-training knowledge test (2nd Test) will be administered. The initiative group will be composed of students who apply concept maps and make in-class maintenance plans after theoretical training. The control group will consist of students who receive theoretical training and implement in-class care plans. After the concept map application, a knowledge test will be applied again (3rd Test).
The data of the research will be collected with the Personal Information Form and Newborn Toxic Stress Information Test.
The personal information form was prepared by the researchers. In shape; There are questions about the student's age, gender, secondary school graduation status, whether they choose the nursing profession willingly, whether they consider the nursing profession suitable for themselves, whether they have heard the term concept map and whether they have applied concept map.
Newborn Toxic Stress Information Test was prepared by researchers. The test consists of 25 multiple choice questions. It consists of true, false and I don't know options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concept Map Group | Experimental | Other: Concept map groupThe intervention group will create a concept map regarding neonatal toxic stress. |
| Control Group | No intervention | –During the application process of the research, knowledge tests will be applied as pre-test and post-test |
Who may qualify
- Ages
- 19 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in the course
- Had not taken this course before
- Accepted to participate in the research
Key exclusion criteria (3 listed)
- Have any records of absence
- Taken this course before
- Graduate of health vocational high school
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 |
|---|---|---|
| Concept map groupThe intervention group will create a concept map regarding neonatal toxic stress. | Other | Concept Map Group |
Primary outcome
Differences of knowledge scores between groups
Time frame: The first knowledge test (pre-test) will be given before class in the first week. Two knowledge tests will be administered for the final test. Total duration is 4 weeks.
First, second and thirth knowledge tests will be applied to measure the level of knowledge. The student can get a minimum of 0 and a maximum of 100 from the knowledge test. Higher scores mean better results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 17030077Sand-Jecklin K. The impact of active/cooperative instruction on beginning nursing student learning strategy preference. Nurse Educ Today. 2007 Jul;27(5):474-80. doi: 10.1016/j.nedt.2006.08.006. Epub 2006 Oct 9.
- Background: PubMed 19040878Gul RB, Boman JA. Concept mapping: A strategy for teaching and evaluation in nursing education. Nurse Educ Pract. 2006 Jul;6(4):199-206. doi: 10.1016/j.nepr.2006.01.001. Epub 2006 Feb 28.
- Background: PubMed 33688544Baliga SS, Walvekar PR, Mahantshetti GJ. Concept map as a teaching and learning tool for medical students. J Educ Health Promot. 2021 Jan 28;10:35. doi: 10.4103/jehp.jehp_146_20. eCollection 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Concept map group in people with Nursing Education and Newborn, run by Çankırı Karatekin University.
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 3 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Differences of knowledge scores between groups (time frame: The first knowledge test (pre-test) will be given before class in the first week. Two knowledge tests will be administered for the final test. Total duration is 4 weeks.). 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 NCT06418815, 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 17 May 2024.