- 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: a Longitudinal Study of Mindfulness Education Course Design, Implementation, and Effectiveness Verification
Study Overview
Detailed Description
A quasi-experimental study design will be used to examine the effects of a new elective course. Convenient sampling will be used to invite nursing students at a university of science and technology in Taiwan. The data will be collected four seven times, including baseline (T0), the end of the course (T1), before and after the nursing practicum (T2, T3).
Participants who enroll in an elective course in mindfulness education constitute the experimental group, while those who do not enroll in the elective form the comparison group. The total number of participants will be 240. Participants will be excluded if they are unwilling to participate in the study or do not complete the consent form.
Intervention: 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. The elective course is designed using the ADDIE model (Analysis, Design, Development, Implementation, 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
-
Taoyuan City, 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 who participated in the elective mindfulness course
Exclusion Criteria:
- under 18 years
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: receive a new elective course
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 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.
|
No Intervention: not receive a new elective course
The comparison group do not enroll in the new elective course named "Mindfulness and Happiness,"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perceived stress at baseline
Time Frame: Data were collected before course intervention
|
The Cohen's Perceived stress scale is a validated multidimensional measure that assesses individuals' stress level.
Higher score indicated higher level of stress.
|
Data were collected before course intervention
|
perceived stress at T0
Time Frame: Data were collected end the course intervention, around 5 months after baseline data collection.
|
The Cohen's Perceived stress scale is a validated multidimensional measure that assesses individuals' stress level.
Higher score indicated higher level of stress.
|
Data were collected end the course intervention, around 5 months after baseline data collection.
|
perceived stress at T1
Time Frame: Data were collected before the nursing practicum, around 6 months after baseline data collection.
|
The Cohen's Perceived stress scale is a validated multidimensional measure that assesses individuals' stress level.
Higher score indicated higher level of stress.
|
Data were collected before the nursing practicum, around 6 months after baseline data collection.
|
perceived stress at T2
Time Frame: Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
The Cohen's Perceived stress scale is a validated multidimensional measure that assesses individuals' stress level.
Higher score indicated higher level of stress.
|
Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
anxiety disorder at baseline
Time Frame: Data were collected before course intervention
|
Löwe's the Generalized Anxiety Disorder 7-Item Scale(GAD-7) generalized anxiety disorder 7-item scale is a validated measure that assesses individuals' anxiety level.
higher score indicated higher level of anxiety.
|
Data were collected before course intervention
|
anxiety disorder at T0
Time Frame: Data were collected end course intervention,around 5 months after baseline data collection.
|
Löwe's the Generalized Anxiety Disorder 7-Item Scale(GAD-7) generalized anxiety disorder 7-item scale is a validated measure that assesses individuals' anxiety level.
higher score indicated higher level of anxiety.
|
Data were collected end course intervention,around 5 months after baseline data collection.
|
anxiety disorder at T1
Time Frame: Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
Löwe's the Generalized Anxiety Disorder 7-Item Scale(GAD-7) generalized anxiety disorder 7-item scale is a validated measure that assesses individuals' anxiety level.
higher score indicated higher level of anxiety.
|
Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
anxiety disorder at T2
Time Frame: Data were collected after the nursing practicum, around 7 months after baseline data collection.
|
Löwe's the Generalized Anxiety Disorder 7-Item Scale(GAD-7) generalized anxiety disorder 7-item scale is a validated measure that assesses individuals' anxiety level.
higher score indicated higher level of anxiety.
|
Data were collected after the nursing practicum, around 7 months after baseline data collection.
|
mindful attention awareness at baseline
Time Frame: Data were collected before course intervention
|
Brown & Ryan's Mindful Attention Awareness Scale is a validated multidimensional measure that assesses individuals' mindful quality.higher
score indicated higher level mindfulness.
|
Data were collected before course intervention
|
mindful attention awareness at T0
Time Frame: Data were collected end the course intervention, around 5 months after baseline data collection.
|
Brown & Ryan's Mindful Attention Awareness Scale is a validated multidimensional measure that assesses individuals' mindful quality.higher
score indicated higher level mindfulness.
|
Data were collected end the course intervention, around 5 months after baseline data collection.
|
mindful attention awareness at T1
Time Frame: Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
Brown & Ryan's Mindful Attention Awareness Scale is a validated multidimensional measure that assesses individuals' mindful quality.higher
score indicated higher level mindfulness.
|
Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
mindful attention awareness at T2
Time Frame: Data were collected after the nursing practicum.around 7 months after baseline data collection.
|
Brown & Ryan's Mindful Attention Awareness Scale is a validated multidimensional measure that assesses individuals' mindful quality.higher
score indicated higher level mindfulness.
|
Data were collected after the nursing practicum.around 7 months after baseline data collection.
|
empathy at baseline
Time Frame: Data were collected before the course intervention
|
Jefferson scale of empathy Chinese version is a validated multidimensional measure that assesses individuals' empathy level.higher
score indicated higher level empathy.
|
Data were collected before the course intervention
|
empathy at at T0
Time Frame: Data were collected end the course intervention, around 5 months after baseline data collection.
|
Jefferson scale of empathy Chinese version is a validated multidimensional measure that assesses individuals' empathy level.higher
score indicated higher level empathy.
|
Data were collected end the course intervention, around 5 months after baseline data collection.
|
empathy at at T1
Time Frame: Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
Jefferson scale of empathy Chinese version is a validated multidimensional measure that assesses individuals' empathy level.higher
score indicated higher level empathy.
|
Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
empathy at at T2
Time Frame: Data were collected after the nursing practicum.around 7 months after baseline data collection.
|
Jefferson scale of empathy Chinese version is a validated multidimensional measure that assesses individuals' empathy level.
higher score indicated higher level empathy.
|
Data were collected after the nursing practicum.around 7 months after baseline data collection.
|
practicum stress at T1
Time Frame: Data were collected before the nursing practicum, around 6 months after baseline data collection.
|
The perceived practicum stress scale is a validated multidimensional measure that assesses individuals' nursing stress from practicum.higher
score indicated higher level stress of practicum.
|
Data were collected before the nursing practicum, around 6 months after baseline data collection.
|
practicum stress at T2
Time Frame: Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
The perceived practicum stress scale is a validated multidimensional measure that assesses individuals' nursing stress from practicum.higher
score indicated higher level stress of practicum.
|
Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
Nursing Competence at T1
Time Frame: Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
The Competence Scale for Clinical Nurse (CSCN) is a validated multidimensional measure that assesses nursing student' nursing competence.
higher score indicated higher level of nursing competence.
|
Data were collected before the nursing practicum,around 6 months after baseline data collection.
|
Nursing Competence at T2
Time Frame: Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
The Competence Scale for Clinical Nurse (CSCN) is a validated multidimensional measure that assesses nursing student' nursing competence.
higher score indicated higher level of nursing competence.
|
Data were collected after the nursing practicum,around 7 months after baseline data collection.
|
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
Keywords
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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