- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361394
The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students
The Impacts of Mindfulness on Psychological Wellbeing and Nursing Competencies Among Nursing Students
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will use a quasi-experimental design to examine the effects of a new elective course for nursing students. Convenience sampling will be used to recruit nursing students from a university of science and technology in Taiwan. Data will be collected at two time points: baseline (T0) and the end of the course (T1).
Participants who enroll in the elective course in mindfulness education will be assigned to the experimental group, whereas those who do not enroll in the elective course will be assigned to the comparison group. The anticipated total enrollment is 240 participants. Participants will be excluded if they are unwilling to participate in the study or do not complete the informed consent form.
Intervention: The experimental group will enroll in the elective course entitled "Mindfulness and Happiness," consisting of 2 hours per week for 18 consecutive weeks. The comparison group will not participate in this course. The elective course is designed using the ADDIE model (Analysis, Design, Development, Implementation, and Evaluation) and is based on Mindfulness-Based Stress Reduction principles.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ya-chu hsiao, EdD
- Phone Number: +886939740890
- Email: yjshiao@mail.cgust.edu.tw
Study Locations
-
-
N/A = Not Applicable
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Taoyuan, N/A = Not Applicable, Taiwan, 333 03
- Recruiting
- Ya-Chu Hsiao
-
Contact:
- ya-chu hsiao, EdD
- Phone Number: +886939740890
- Email: yjshiao@mail.cgust.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nursing students enrolled at the participating university
- Aged 18 years or older
- Willing to participate in the study
- Able to provide written informed consent
- Enrolled in the elective course "Mindfulness and Happiness" for assignment to the experimental group, or not enrolled in the course for assignment to the comparison group
Exclusion Criteria:
- Younger than 18 years
- Unwilling or unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Mindfulness and Happiness elective course
Participants in the experimental group will enroll in the elective course "Mindfulness and Happiness," which consists of 2 hours per week for 18 consecutive weeks.
|
Participants in the experimental group will receive the "Mindfulness and Happiness" elective course, consisting of 2 hours per week for 18 consecutive weeks.
|
|
No Intervention: No Intervention: Comparison group
Participants in the comparison group will not enroll in the elective course "Mindfulness and Happiness."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Perceived Stress Scale is a validated self-report measure of perceived stress.
Higher scores indicate greater perceived stress
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
Generalized Anxiety Disorder 7-Item Scale score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a validated self-report measure of anxiety severity.
Higher scores indicate greater anxiety severity.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
Mindful Attention Awareness Scale score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Mindful Attention Awareness Scale is a validated self-report measure of mindfulness.
Higher scores indicate greater mindfulness.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
Chinese version of the Jefferson Scale of Empathy score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Chinese version of the Jefferson Scale of Empathy is a validated self-report measure of empathy.
Higher scores indicate greater empathy.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
The Problematic Internet Use Questionnaire-Short Form (PIUQ-SF) score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Problematic Internet Use Questionnaire-Short Form (PIUQ-SF) assesses problematic internet use, including obsession, neglect, and control disorder.
Higher scores indicate more severe problematic internet use.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
Taiwan Five Facet Mindfulness Questionnaire score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Taiwan Five Facet Mindfulness Questionnaire (Taiwan FFMQ) assesses five facets of mindfulness.
Higher scores indicate greater mindfulness.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
|
Depression, Anxiety, and Stress Scale-21 Score
Time Frame: Baseline (T0) and end of course (T1, 18 weeks)
|
The Depression, Anxiety, and Stress Scale-21 (DASS-21) is a validated self-report measure of depression, anxiety, and stress.
Higher scores indicate greater psychological distress.
|
Baseline (T0) and end of course (T1, 18 weeks)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORPFIN0021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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