## Protocol Section
### Identification Module
**NCT ID:** NCT06418815

**Brief Title:** Concept Map on Toxic Stress in Newborns

**Official Title:** Effect of Concept Map on Nursing Students' Ability to Assess Toxic Stress in Newborns: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** CKU12
#### Organization
**Class:** OTHER
**Full Name:** Çankırı Karatekin University
### Status Module
#### Completion Date
**Date:** 2024-06-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-13

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Çankırı Karatekin University

#### Responsible Party

**Investigator Affiliation:** Çankırı Karatekin University

**Investigator Full Name:** Aylin PEKYİGİT

**Investigator Title:** Research Assistant PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Nursing Education

- Newborn

**Keywords:**

- Concept map

- Nursing education

- Toxic stress

- Newborn

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention group will create a concept map regarding neonatal toxic stress.

**Intervention Names:**

- Other: Concept map group

**Label:** Concept Map Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** During the application process of the research, knowledge tests will be applied as pre-test and post-test

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Concept Map Group

**Description:** The intervention group will create a concept map regarding neonatal toxic stress.

**Name:** Concept map group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Enrolled in the course
* Had not taken this course before
* Accepted to participate in the research

Exclusion Criteria:

* Have any records of absence
* Taken this course before
* Graduate of health vocational high school

**Healthy Volunteers:** True

**Maximum Age:** 27 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### References Module

#### References

**Citation:** 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.

**PMID:** 17030077

**Citation:** Gul 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.

**PMID:** 19040878

**Citation:** Baliga 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.

**PMID:** 33688544

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
