Psychological Well-beingNCT06361394
The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students
A study testing Mindfulness and Happiness elective course in people with Psychological Well-being and Mindfulness, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-being, Mindfulness, Problematic Internet Use
- What is being tested?
- Mindfulness and Happiness elective course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Younger than 18 years
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impacts of Mindfulness on Psychological Wellbeing and Nursing Competencies Among Nursing Students
The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students.
Read the 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.
- Being tested
- Mindfulness and Happiness elective course
- Keywords
- Empathy, Stress, Anxiety, Nursing students, Mindfulness, Problematic internet use
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Happiness elective courseOther
Participants in the experimental group will receive the "Mindfulness and Happiness" elective course, consisting of 2 hours per week for 18 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mindfulness and Happiness elective course | Experimental | 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. Receives: Other: Mindfulness and Happiness elective course |
| No Intervention: Comparison group | No intervention | Participants in the comparison group will not enroll in the elective course "Mindfulness and Happiness." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale score
The Perceived Stress Scale is a validated self-report measure of perceived stress. Higher scores indicate greater perceived stress
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Generalized Anxiety Disorder 7-Item Scale score
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a validated self-report measure of anxiety severity. Higher scores indicate greater anxiety severity.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Mindful Attention Awareness Scale score
The Mindful Attention Awareness Scale is a validated self-report measure of mindfulness. Higher scores indicate greater mindfulness.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Chinese version of the Jefferson Scale of Empathy score
The Chinese version of the Jefferson Scale of Empathy is a validated self-report measure of empathy. Higher scores indicate greater empathy.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
The Problematic Internet Use Questionnaire-Short Form (PIUQ-SF) score
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.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Taiwan Five Facet Mindfulness Questionnaire score
The Taiwan Five Facet Mindfulness Questionnaire (Taiwan FFMQ) assesses five facets of mindfulness. Higher scores indicate greater mindfulness.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Depression, Anxiety, and Stress Scale-21 Score
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.
Measured: Baseline (T0) and end of course (T1, 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start10 Feb 2025
- Primary completion30 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Chu Hsiao, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361394
- Sponsor's protocol ID
- CORPFIN0021
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IRB does not allow
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Mindfulness on Psychological Wellbeing and Nursing Competencies Among Nursing Students
- ClinicalTrials.gov ID
- NCT06361394
- Acronym / sponsor ID
- CORPFIN0021
- Keywords
- Empathy, Stress, Anxiety, Nursing students, Mindfulness, Problematic internet use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mindfulness and Happiness elective course | Experimental | Other: Mindfulness and Happiness elective courseParticipants in the experimental group will enroll in the elective course "Mindfulness and Happiness," which consists of 2 hours per week for 18 consecutive weeks. |
| No Intervention: Comparison group | No intervention | –Participants in the comparison group will not enroll in the elective course "Mindfulness and Happiness." |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Younger than 18 years
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Happiness elective courseParticipants in the experimental group will receive the "Mindfulness and Happiness" elective course, consisting of 2 hours per week for 18 consecutive weeks. | Other | Experimental: Mindfulness and Happiness elective course |
Primary outcome
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
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. IRB does not allow
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Happiness elective course in people with Psychological Well-being and Mindfulness, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale score (time frame: Baseline (T0) and end of course (T1, 18 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.