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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06392100
Other study ID # MKC-24MMHIS148e
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 30, 2025

Study information

Verified date April 2024
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized clinical trial design. The research subjects were the internship nursing students in the nursing department of a nursing school in the northern Taiwan. The experimental group received mindfulness-based stress reduction intervention, while the control group received routine care with weekly line care messages from class instructors. Both groups took the post-test before the internship (T0), during the internship (T1), after the internship (T2), and one month after the internship (T3), a total of 4 times. The contents include psychological well-being scale; anxiety, depression, stress scale and mental scale.


Description:

Students need to learn a lot of new medical knowledge and skills during clinical internships, which requires time and effort. However, this kind of learning pressure may put a considerable burden on nursing students, especially anxiety, depression, and stress. Through effective coping strategies, students can improve their confidence in facing clinical situations. Mindfulness-based stress reduction is a stress-reduction method based on mindfulness meditation. It can relieve the physical and mental stress and anxiety of high-stress people, improve sleep quality, chronic fatigue, and enhance concentration. The purpose of this study is to explore the effectiveness of mindfulness-based stress reduction intervention on anxiety, depression, and stress in clinical practice of nursing students. This study adopted a randomized clinical experimental research design. Nursing students from a fifth-level college in the north were selected as the research subjects. A total of 80 people were recruited. Nursing intern students who were willing to participate in the study were randomly assigned and divided into an experimental group of 40 people and a control group. 40 people, the experimental group participated in the mindfulness-based stress reduction course for 8 weeks. The mindfulness-based stress reduction course was led by a certified mindfulness-based stress reduction teacher, once a week, 2 hours each time, for 8 consecutive weeks; the students in the control group received weekly line care messages from the class instructor. Research tools include the General Health Status Scale, Anxiety and Depression Stress Scale, and Mental Resilience Scale. The data were analyzed using SPSS20.0 for Windows.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 30, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - (1) Nursing students during clinical practicum (2) Clear consciousness. Exclusion Criteria: -(1) Students diagnosed with schizophrenia, anxiety, depression or affective psychosis. (2)Taking anti-anxiety medicine treatment or anti-depressant medicine treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-Based Intervention
Mindfulness-based stress reduction interventions include: breathing awareness, loving-kindness meditation, body scan, walking meditation, sitting body awareness, eating meditation, and deep breathing exercises.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

References & Publications (4)

Dong C, Xia L, Zhao C, Zhang X, He J, Zhang G, Zhang J. Prospective association between perceived stress and anxiety among nursing college students: the moderating roles of career adaptability and professional commitment. BMC Psychiatry. 2023 Jun 1;23(1): — View Citation

Gurdil Yilmaz S, Yildiz Karadeniz E, dem Lafci D. Clinical-practice stress levels and factors affecting these on first-year nursing students. Perspect Psychiatr Care. 2022 Oct;58(4):3009-3015. doi: 10.1111/ppc.13070. Epub 2022 Mar 22. — View Citation

O'Driscoll M, Byrne S, Mc Gillicuddy A, Lambert S, Sahm LJ. The effects of mindfulness-based interventions for health and social care undergraduate students - a systematic review of the literature. Psychol Health Med. 2017 Aug;22(7):851-865. doi: 10.1080/ — View Citation

Uysal N, Caliskan BB. The effects of mindfulness-based stress reduction on mindfulness and stress levels of nursing students during first clinical experience. Perspect Psychiatr Care. 2022 Oct;58(4):2639-2645. doi: 10.1111/ppc.13104. Epub 2022 Apr 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mental Health Psychological Well-Being Scale (PWBS-18) : Ryff & Keyes (1995) proposed that happiness is not only a happy psychological experience, but also a perfect and true performance through one's own efforts. The original scale has 6 facets and 25 questions. Pre-intervention(T0)?Two week after clinical practium begins (T1)?Four week after clinical practium begins(T2)?Two months after clinical practium(T3)
Primary Anxiety, Depression, Stress Depression, Anxiety and Stress Scale - 21 Items (DASS-21):Developed by scholars at the University of New South Wales in Australia in 1995, it is an internationally authoritative psychological stress assessment tool. It uses a short version of 21 questions to assess common depressive emotions such as depression, anxiety, and stress. There are 21 questions in total, which combine subjective The degree of various induced emotional states is used as an evaluation index, using a 4-point scale, where 1 means not consistent, 2 means sometimes consistent, 3 means usually consistent, and 4 means always consistent. Pre-intervention(T0)?Two week after clinical practium begins (T1)?Four week after clinical practium begins(T2)?Two months after clinical practium(T3)
Secondary Resilience Resilience Scale (RS):The Resilience Scale of Wagnild and Young (1993) focuses on measuring the resilience of individuals at the psychological level, using a seven-point Likert scale with a total of 25 questions. Pre-intervention(T0)?Two week after clinical practium begins (T1)?Four week after clinical practium begins(T2)?Two months after clinical practium(T3)
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