Clinical trial NCT06440837: Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students
Official title: Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Stress
Nursing Students
Keywords: health education
IMB model
cluster-randomized controlled study
Lead sponsor: Changzhi Medical College
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The random sequence generation will be implemented at the cluster level rather than the individual level to prevent sample contamination. Dormitories meeting the eligibility criteria will be coded and randomly assigned to either the intervention group or the control group. The random assignment will be executed using computer-generated software on a research randomization website, with a 1:1 allocation ratio.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. cluster

   * dormitories located in Changzhi Medical College
   * The residents in the dormitory are all nursing students that registered in fist-semester
2. individual

   * Registered in undergraduate nursing program
   * Registered in the first-semester study
   * Have a mobile device that can access internet
   * Voluntarily participated in this study

Exclusion Criteria:

1. cluster

   * 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.
2. individual

   * Diagnosed with mental problems or severe physical problems, e.g., depression, generalized anxiety disorder, or diabetes
   * Previous participation in other stress intervention studies

Primary outcomes:
measure: stress sub-scale of DASS-21
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Secondary outcomes:
measure: Stress Knowledge Questionnaire
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
measure: Stress Mindset Measure-General
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
measure: Multidimensional Scale of Perceived Social Support
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
measure: Self-Compassion Scale Short Form
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
measure: Connor-Davidson Resilience Scale
timeFrame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: University Putra Malaysia
name: binti Ahmad Norliza, Dr
role: STUDY_DIRECTOR
References:
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citation: Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
citation: Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.
citation: Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.