Psychological Stress Clinical Trial
Official title:
Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
| Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
| Completed |
NCT02629016 -
Stress Reduction: A Pilot Study With Adolescents
|
N/A | |
| Completed |
NCT02541240 -
Effects of an Intervention to Enhance Resilience in Physical Therapy Students
|
N/A | |
| Completed |
NCT01406028 -
Does Emotional Support Decrease In Vitro Fertilization Stress?
|
N/A | |
| Completed |
NCT00121160 -
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
|
Phase 1 | |
| Completed |
NCT02621775 -
Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
|
N/A | |
| Recruiting |
NCT04474418 -
Psychometric Characterization of Patients With Cardiac Arrhythmias
|
||
| Completed |
NCT03310112 -
Mindfulness Training in U.S. Army Cohorts
|
N/A | |
| Terminated |
NCT03893617 -
Brief Stresses Experimental Study
|
Phase 1 | |
| Active, not recruiting |
NCT05542498 -
Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation
|
N/A | |
| Completed |
NCT02394899 -
Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
|
N/A | |
| Terminated |
NCT00962273 -
The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
|
N/A | |
| Completed |
NCT00451126 -
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST
|
N/A | |
| Completed |
NCT06051500 -
Psychological and Physiological Effects of Different Objects of Breath Meditation
|
N/A | |
| Completed |
NCT02801045 -
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
|
N/A | |
| Completed |
NCT03308344 -
Mindfulness Training in Military Spouses
|
N/A | |
| Recruiting |
NCT06029348 -
Cerebrovascular Health and Resilience in Midlife
|
N/A | |
| Completed |
NCT05869006 -
The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity
|
N/A | |
| Completed |
NCT04484649 -
Sleeping Healthy/Living Healthy Development
|
N/A |