The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students

Students Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361394
• Other study ID #: CORPFIN0021
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Chang Gung University of Science and Technology
• Contact: ya-chu hsiao, EdD
• Phone: +886939740890
• Email: yjshiao[@]mail.cgust.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2025
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Nursing students who participated in the elective mindfulness course

Exclusion Criteria:

• under 18 years

Related Conditions & MeSH terms

• Students

Intervention

Other:
• mindfulness 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 comparison group will not participate in this course.

Locations

Country	Name	City	State
Taiwan	Ya-Chu Hsiao	Taoyuan City	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perceived stress at baseline	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
Primary	perceived stress at T0	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.
Primary	perceived stress at T1	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.
Primary	perceived stress at T2	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.
Primary	anxiety disorder at baseline	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
Primary	anxiety disorder at T0	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.
Primary	anxiety disorder at T1	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.
Primary	anxiety disorder at T2	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.
Primary	mindful attention awareness at baseline	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
Primary	mindful attention awareness at T0	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.
Primary	mindful attention awareness at T1	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.
Primary	mindful attention awareness at T2	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.
Primary	empathy at baseline	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
Primary	empathy at at T0	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.
Primary	empathy at at T1	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.
Primary	empathy at at T2	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.
Primary	practicum stress at T1	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.
Primary	practicum stress at T2	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.
Primary	Nursing Competence at T1	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.
Primary	Nursing Competence at T2	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.