Clinical trial NCT06165471: The Effectiveness of a Mobile Application for Teaching Clinical Nursing Skill at a Higher Education Institution in Chenzhou, China
Official title: The Effectiveness of a Mobile Application for Teaching Clinical Nursing Skill at a Higher Education Institution in Chenzhou, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Keywords: Pretest-post test and intervention
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The general objective of this study is to validate a mobile application as a pedagogical tool compared to in-person nursing educational instruction for teaching clinical nursing skills and evaluate the effectiveness of clinical nursing skills for nursing students.

The study design is a basic experimental study design, randomized control trial (RCT) design; the dependent variables measured in this study are skills, self-directed learning ability, online academic emotion, and satisfaction by using pre- and posttests; two groups are participating in this study; experimental and control group. The control group treatment is traditional face-to-face teaching, and the experimental group intervention is online and offline blended learning based on the Chaoxing app. The study process includes four steps：

1. To develop surgical nursing practical online courses using Chaoxing mobile app.
2. Perform the pre-test (basic sociological information, self-directed learning ability surveys ).
3. Nursing clinical practice skills education intervention.
4. Perform a posttest (assess practical skills, self-directed learning ability, online academic emotion, and satisfaction).

Detailed description: Study title:

The Effectiveness of A Mobile Application for Teaching Clinical Nursing Skill at A Higher Education Institution in Chenzhou, China

General objective:

The general objective of this study is to validate a mobile application as a pedagogical tool compared to in-person nursing educational instruction for teaching clinical nursing skills and evaluate the effectiveness of clinical nursing skills for nursing students.

The study design is a basic experimental study design, randomized control trial (RCT) design; the dependent variables measured in this study are skills, self-directed learning ability, online academic emotion, and satisfaction by using pre- and posttests; two groups are participating in this study; experimental and control group. The control group treatment is traditional face-to-face teaching, and the experimental group intervention is online and offline blended learning based on the Chaoxing app. The study process includes four steps：

1. To develop surgical nursing practical online courses using the Chaoxing mobile app.
2. Perform the pre-test (basic sociological information, self-directed learning ability surveys ).
3. Nursing clinical practice skills education intervention.
4. Perform a posttest (assess practical skills, self-directed learning ability, online academic emotion, and satisfaction).

Study Location:

This study will be conducted at Xiangnan University in Chenchou city Hunan province in China, Chenzhou city is in the southeast of China.

Study Design:

The study design was a prospective, single-blind experimental design, randomized control trial (RCT) design.

Study population \& Setting The sample will consist of third-year undergraduate nursing students at a university in Chenzhou, southeast China. They are between 19 and 22 years old. In the early stage, students have completed one year of basic medical courses and mastered the relevant knowledge of human anatomy, physiology, and pathology. Students are active in thinking, have intense curiosity, and have a certain ability to understand and self-learning. However, students are exposed to clinical practice skills for the first time and have little exposure to clinical practice in the early stage, resulting in poor comprehensive analysis ability and unfamiliar skills operation.

Sample size calculation:

The sample size estimate was calculated based on the primary measure of self-learning ability. Sample size calculation is performed by using G\*POWER software (version 3.1.9.4) and consists of the following steps: (1) Select the test family (t-test ), (2) Select the statistical test (Means: Difference between two independent means (two groups)), (3) Select the Type of power analysis (A priori: Compute required sample size - given α, power, and effect size), (4) Select tails (two), α err prob (0.05), Power (1-β err prob) (0.95), Allocation ratio N2/N1 is one (each group = n) n= the estimated sample size. Effect Size (ES) = 0.55, automatically calculated by G\*Power software, depending on the sample size of the previous studies (Luo Qiaoling, 2020) ,(Zhang Y H,2015),(Li X M, 2021), the effect size is calculated by selecting these similar studies fitted to the researchers' study, the reasonable sample size which is (n=166) will be taken as the minimum sample size for this study, and the minimum sample size for each group will be 83 participants.

Sampling method:

Cluster random sampling was used after obtaining ethical approval and permission to conduct the study from the Ethics Committee of Xiangnan University, China (Ethics Registration No. 2022YXLL030) and the Jawatankuasa Etika Penyelidikan Manusia, Universiti Sains Malaysia (JEPeM-USM), the study protocol code USM/JEPeM/KK/23020172. The cluster sampling method of the participants was used to select all the undergraduate students in 2021 from the School of Nursing of Xiangnan University, Chenzhou, China. Computer-generated randomization (Random Allocation Software, version 1.0) was applied in blocks to allocate the classes by distributing them into two arms: one is the control group, and the other is the experimental group.

Study process steps:

(i) In the Pre-Test, the estimated time to fill will be 15 minutes maximum; it consists of 2 sections. The first section includes the consent form and ten questions about demographical data; the second section includes a self-directed learning ability assessment and consists of 20 MCQ questions. The pre-test will be filled out by both the control and interventional groups.

(ii) The intervention, volunteer participation, takes about two months for both the control and interventional groups. The control group will adopt the traditional face-to-face teaching mode, and the interventional group will adopt the mode of online and offline blended learning based on the Chaoxing app.

(iii) In the post-test, the interventions are finished, and an examination evaluation will be immediately given to both group's participants, including online academic emotional, self-directed learning ability, and class satisfaction assessment with a total of 55 MCQ questions, which will be 30 minutes maximum.

Ethical Considerations：

1. Permission to conduct the study Regarding ethical considerations, approval for the study was obtained from the Jawatankuasa Etika Penyelidikan Manusia, Universiti Sains Malaysia (JEPeM-USM), the study protocol code USM/JEPeM/KK/23020172; Moreover, ethical approvals to conduct the study was obtained from the Ethics Committee of Xiangnan University, China (Ethics Registration No. 2022YXLL030).
2. Subject vulnerability: Participants will be informed of their right to participate voluntarily and to withdraw from the study at any time without being penalized or losing the benefits to which they would otherwise be entitled. Informed consent was signed after all procedures were explained to each participant, and they agreed to participate in the study. For participants who need clarification on the study, the researchers will detail the instructions so that they fully understand and then agree to participate. During this study, the researcher is not a teacher as she is on study leave and not doing any teaching work. She is a researcher who will conduct the study and recruit the students. All teaching processes and materials will be handled by the teaching team. The researcher will not affect the student's evaluation during the study period.
3. Privacy and confidentiality: All personal data, including consent forms and questionnaire data obtained from study participants, will be kept strictly confidential and used only for academic and research purposes. In addition, the subject's name will not appear on any documents to maintain anonymity.
4. Conflict of interest: The principal investigator is the teacher in the faculty where data collection takes place; there are no conflicts of interest in the study, nor was there anything that might affect or prejudice the professional judgment in the study.
5. Community sensitivities and benefits: This study does not have any relation with sensitivity to the community because this study only involves a student and the impact of the technology used for their education. If the student uses the technology for nursing education, the benefit will go to the students directly. At the end of the study, the control group could also use the online course on the Chaoxing app if proven effective.
6. Incentive, compensation \&/or reimbursement: Participants in this study do not incur any fees. The study will not offer any monetary or other rewards in response to participation.
7. The risks in this study: The study was free from any potential hazards or adverse effects on participants; no dedicated product will be used in this study.

Eligibility criteria: Inclusion Criteria:

* i) Full-time undergraduate nursing students in grades 3 who understand Chinase language.
* ii) Owning at least one smartphone, tablet or portable laptop.

Exclusion Criteria:

* i) Repeat students.
* ii) Sick (matter) leave, Suspension of schooling.
* iii) Can not fully participate in or cooperate with.

Primary outcomes:
measure: The effects of surgical nursing practical online courses using Chaoxing app on the skills score
timeFrame: Hence the interventions finished, and an examination evaluation will be immediately given to the both groups participants.
measure: Self-directed learning ability
timeFrame: Hence the interventions finished, and an examination evaluation will be immediately given to the both groups participants.
Secondary outcomes:
measure: Online academic emotional assessment
timeFrame: Hence the interventions finished, and an examination evaluation will be immediately given to the both groups participants.
measure: Class satisfaction assessment
timeFrame: Hence the interventions finished, and an examination evaluation will be immediately given to the both groups participants.
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: Afang Li
state: Hunan
Study officials:
affiliation: Xiangnan University, China
name: Afang Li
role: PRINCIPAL_INVESTIGATOR
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