Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students

NCT ID: NCT06440837

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Psychological Stress Nursing Students

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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wait-list

participant in this group will not accept any psychological intervention content during experimental period. After the study, the intervention will be distributed for free.

Group Type NO_INTERVENTION

No interventions assigned to this group

IMB stress self-management health education

Participants in this arm will receive an online "IMB stress self-management health education" program. The health education intervention program contains eight module topics.

Group Type EXPERIMENTAL

IMB stress self-management health education

Intervention Type BEHAVIORAL

The health education intervention program contains eight module topics: stress-related knowledge, the thinking and mentality under stress, social support, take care of your suffering, manage your difficult emotions, acceptance, embrace a better life, ending. One topic or session is delivered by weeks, each session lasting 30-40 minutes.

Interventions

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IMB stress self-management health education

The health education intervention program contains eight module topics: stress-related knowledge, the thinking and mentality under stress, social support, take care of your suffering, manage your difficult emotions, acceptance, embrace a better life, ending. One topic or session is delivered by weeks, each session lasting 30-40 minutes.

Intervention Type BEHAVIORAL

Other Intervention Names

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"information-motivation-behavioral skills" stress self-management health education

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changzhi Medical College

OTHER

Sponsor Role lead

Responsible Party

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Dong Xiujuan

research leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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binti Ahmad Norliza, Dr

Role: STUDY_DIRECTOR

University Putra Malaysia

Central Contacts

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Dong Xiujuan, Master

Role: CONTACT

+8618334526688

References

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Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

Reference Type RESULT
PMID: 7726811 (View on PubMed)

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.

Reference Type RESULT
PMID: 12964174 (View on PubMed)

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.

Reference Type RESULT
PMID: 23437923 (View on PubMed)

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.

Reference Type RESULT
PMID: 2280326 (View on PubMed)

Other Identifiers

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ChangzhiMC

Identifier Type: -

Identifier Source: org_study_id

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