Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- stress sub-scale of DASS-21
研究概览
简要总结
The aim of this cluster randomized controlled study is to test the effectiveness of IMB stress self-management health education on nursing students registered in first semester. The main question aims to answer are: Does IMB stress self-management health education program improving stress in nursing students? Researcher will compare wait-list group without any intervention to experimental group which received IMB stress self-management health education, to see if IMB stress self-management health education works to improving stress among nursing students.
Participants will Attend IMB stress self-management health education program once a week for 8 weeks. In addition, complete questionnaires at pre-intervention, post-intervention, 1-month post-intervention, 3-months post-intervention, 6-months post-intervention.
详细描述
This study intends to select first-year undergraduate nursing students registered in October 2024 at Changzhi Medical College in Shanxi as the sampling population. A total of 120 eligible individual samples in eligible clusters will be screened according to inclusion and exclusion criteria, and the cluster samples will be randomly assigned to either the wait-list group or the intervention group. Participants in wait-list group will not receive any intervention, while participants in intervention group will receive IMB-based stress self-management health education. The intervention will last for 8 weeks, with one module delivers by weeks. Each module will include a 30-40 minute lecture combined with exercises, discussions, and role-playing activities. Measurements will be taken before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. These measurements will include the Stress Knowledge Questionnaire, the Multidimensional Scale of Perceived Social Support, the Self-Compassion Scale, the Resilience Scale, and the stress sub-scale of the Depression Anxiety Stress Scale.
The study data will be analyzed using the intention-to-treat (ITT) method. Continuous data will be described using mean (standard deviation) or median (interquartile range), and categorical data will be described using frequency and percentage. Repeated measures ANOVA will be used to compare differences between the two groups before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. Generalized linear models (GMM) will be utilized to determine the effects of IMB-based stress self-management health education on the variables immediately post-intervention, and at 1 month, 3 months, and 6 months post-intervention, while controlling for confounding variables. Sensitivity analysis will be performed and reported. The mean estimates will be set with a 95% confidence interval, and the significance level will be set at P < 0.05.
This study aims to explore new low-cost approaches for current college student mental health education, improve stress self-management abilities and stress levels among nursing students, prevent mental disorders, and promote mental health. To ensure the safety of participants throughout the study, the research team will strictly adhere to ethical standards and undergo review and supervision by the ethics committee. Informed consent will be obtained from participants, and their privacy and personal information will be kept confidential, not disclosed or misused. Regular safety monitoring and risk assessments will be conducted. The research protocol will be strictly followed, and psychological counseling services will be provided to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
To ensure allocation concealment, an external party using a "third-party" allocation approach will be employed. This involves using a research assistant to maintain allocation concealment. The list of eligible dormitories will be sent to a second research assistant, who will then carry out the sequence generation described above. Neither the researchers nor other research personnel will be aware of the specific dormitory group assignments.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •dormitories located in Changzhi Medical College
- •The residents in the dormitory are all nursing students that registered in fist-semester
- •Registered in undergraduate nursing program
- •Registered in the first-semester study
- •Have a mobile device that can access internet
- •Voluntarily participated in this study
排除标准
- •The residents in the dormitory are mixed with students from other majors except nursing.
- •The residents in the dormitory are mixed with nursing students from other grade.
- •Diagnosed with mental problems or severe physical problems, e.g., depression, generalized anxiety disorder, or diabetes
- •Previous participation in other stress intervention studies
结局指标
主要结局
stress sub-scale of DASS-21
时间窗: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
The DASS-42 is a 42 item self-report scale is designed to measure the emotional states of depression, anxiety and stress. Each of the 42 questions in DASS is scored on a 4-point scale ranging from 0("Did not apply to me at all") to 3("Applied to me very much, or most of the time"). Scores for Stress is calculated by summing the scores for the 14 items: 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39. Total score of the stress subscale ranged from 0 to 42, the level of stress can be categorized five level based on total score actually measured: normal (score from 0 to 14), mild (score from 15 to 18), moderate (score from 19 to 25), Sever (score from 26 to 33), extreme sever (score from 34 above), therefore, higher score indicate higher level of stress.
次要结局
- Connor-Davidson Resilience Scale(baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.)
- Multidimensional Scale of Perceived Social Support(baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.)
- Stress Knowledge Questionnaire(baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.)
- Stress Mindset Measure-General(baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.)
- Self-Compassion Scale Short Form(baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.)
研究者
Dong Xiujuan
research leader
Changzhi Medical College