Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440837
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students
Sponsor:
Changzhi Medical College
Organization:
Changzhi Medical College
Study Overview
Official Title:
Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students Shanxi Province China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMB
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
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 005
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
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 005
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None