- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544355
A Mindfulness-Based Stress Reduction Training Program Model
A Mindfulness-Based Stress Reduction Training Program Model for Empowering Nursing Students
Mindfulness-based practices are used to regulate mood, alleviate or completely eliminate symptoms that cause stress and depression, and positively influence well-being. The Mindfulness-Based Stress Reduction Program is a mindfulness approach applied to individuals with physical and psychological complaints and aims to reduce stress levels (Kral et al., 2022).
The Mindfulness-Based Stress Reduction Program is a widely used meditation practice that includes individual or group practices aimed at creating awareness in individuals, such as breath awareness meditation, body scan, walking meditation, and yoga, taught by a practitioner. Each of the practices involves focusing attention on the experience of the present moment (Kral et al., 2022). However, it aims for individuals under stress to respond consciously to situations instead of automatically reacting (Gotink et al., 2016). Unlike traditional meditation, the Mindfulness-Based Stress Reduction Program is based on focused attention, the individual's clear observation of themselves and events, and breath meditation. The aim is for individuals to recognize their automatic responses to events and to transform their existing responses without judgment (Gotink et al., 2016).
The main objective of this study is to determine the effect of a mindfulness-based stress reduction training program on emotion regulation and stress levels of nursing students, thereby enabling them to gain competence in this area.
Study Overview
Status
Conditions
Detailed Description
Mindfulness practices, an approach to skillfully responding to and increasing awareness of emotional distress and maladaptive mental processes, are a widely used method in various fields, primarily healthcare, but also in business, art, politics, and indeed everywhere humans are involved (Wrenn, 2022). When examining studies on mindfulness practices; It has been reported to reduce pain, substance (smoking, alcohol, caffeine, drug abuse) and social media addiction (Tang et al., 2016), improve sleep quality and duration, regulate blood sugar and blood pressure, strengthen the immune system (Black and Slavich 2016), improve quality of life (Van Gordon et al., 2017), and have positive effects on conditions such as anxiety, stress, depression, and burnout (Klainin-Yobas et al., 2016; Tomlinson et al. 2018).
Mindfulness-based practices have been identified as an effective method for healthcare professionals to prevent, manage, and increase psychological resilience related to stress, anxiety, and burnout (Coster et al., 2020; Yüksel and Bahadır Yılmaz, 2020). Mindfulness is a way of paying attention to what is happening in the present moment, noticing the quality of attention, and accepting all that is noticed without judgment. In other words, it plays a mediating role in managing challenging situations and emotions such as stress, anxiety, and anger in daily life by enabling individuals to connect with their emotions. The literature indicates that mindfulness and mindfulness-based approaches are widely used worldwide, both in clinical settings and in daily life (Alkhawaldeh et al., 2024; Karo et al., 2024; Yosep et al., 2023). Studies have shown that mindful awareness is effective in reducing conditions such as stress, anxiety, and depression (Alkhawaldeh et al., 2024; Karo et al., 2024). Furthermore, mindful awareness is reported to be a significant predictor of self-compassion, psychological well-being, empathy, compassion, and self-efficacy (Alkhawaldeh et al., 2024; Cura and Atay, 2023; Yosep et al., 2023). Additionally, enhanced mindful awareness is a significant predictor of increased creativity and clinical competence in daily life, effective emotion management, and improved communication self-efficacy (Sundling et al., 2017). Studies in the field of nursing have reported that mindfulness is predominantly associated with and contributes to stress, anxiety (Ghawadra et al., 2019), depression, burnout (Ceravolo and Raines, 2019; Suleiman Martos et al., 2020), and quality of life (Ceravolo and Raines 2019).
It has been noted that nursing students are exposed to higher levels of stress compared to their peers in other disciplines due to both academic and clinical practices, and therefore mindfulness-based practices have gained importance (Bartlett et al., 2016). It has been stated that mindfulness-based practices have positive effects on the psychological well-being of students. A multicenter cross-sectional study conducted in Northern Italy in 2020 reported that approximately 70% of nursing students experienced significant psychological distress. However, it was noted that students with higher levels of mindfulness experienced lower levels of psychological distress. Based on these findings, the importance of mindfulness-based practices specifically designed for nursing students as a protective factor against stress has been emphasized (Salvarani et al., 2020). Furthermore, it has been reported that nursing students with high mindfulness are better able to understand the perspectives of others, show compassion, and manage negative emotional states more positively (Ardenghi et al., 2023).
It is stated that the Mindfulness-Based Stress Reduction Program helps nursing students reduce their stress levels and regulate their mood, thus enabling them to perceive the educational process more positively and contributing to increased professional success. Studies in the international literature demonstrate the effectiveness of the Mindfulness-Based Stress Reduction Program used to reduce stress levels in nursing students (Chen et al., 2021; Coster et al., 2020; Veigh et al., 2021). McVeigh et al. (2021), in their systematic review, also stated that "mindfulness-based practices" provide effective strategies for nursing students in stress management, developing self-awareness, and improving clinical performance. Another study emphasized that mindfulness-based stress reduction practices increased the awareness levels of nursing students and led to a decrease in their stress levels (Yüksel and Bahadır Yılmaz, 2020).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rujnan Tuna, PhD
- Phone Number: +902162803153
- Email: rujnantuna@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study,
- Being a nursing student,
- Having completed the pre-test,
- Not having a stress score within the normal range,
- Not having received any prior training on this subject,
- Not having a severe psychiatric illness (psychosis, schizophrenia, etc.) diagnosed by a physician and requiring medication.
Exclusion Criteria:
- Not volunteering to participate in the study,
- Not being a nursing student,
- Not completing the pre-test,
- Having a stress score within the normal range in the pre-test results,
- Not having received any prior training on this subject,
- Having a psychiatric illness (psychosis, schizophrenia, etc.) diagnosed by a physician and requiring medication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The mindfulness group-Mindfulness-Based Stress Reduction Program (Group 1)
A pre-test will be administered before the training.
Nursing students who agree to participate in the study and are randomly assigned to the mindfulness group (Group 1) will receive face-to-face training on the "Mindfulness-Based Stress Reduction Program" for 45-60 minutes once a week for six weeks.
The training will be given by a researcher trained in the mindfulness-based stress reduction program.
Following the training, a post-test will be administered to the mindfulness group (Group 1).
|
Week 1: Introduction, defining group dynamics, establishing group rules. Week 2: What is mindfulness? The breathing exercise, autopilot, raisin eating exercise. Homework: Creating mindfulness routines (brushing teeth, walking, showering, cooking or eating). Week 3: Stress, the physiology of stress, and the relationship between mindfulness and stress. Sitting meditation. Homework: Doing sitting meditation twice a week. Week 4: The relationship between thought, emotion, and behavior, Body scan meditation. Homework: Doing body scan meditation one day, sitting meditation the next. Doing 10-finger exercises. Week 5: Coping with challenging emotions and self-compassion. Self-compassion meditation. Homework: Caring for a plant or planting a flower. One day body scan, one day self-compassion meditation. Week 6: Program evaluation and closing.
Other Names:
|
|
Placebo Comparator: The life skills workshop group-Lifestyle Management and Well-being Workshop (Group 2)
A pre-test will be administered before the training.
Nursing students who agree to participate in the study and are randomly assigned to the life skills workshop group (Group 2) will receive face-to-face training on the "Lifestyle Management and Well-being Workshop" for 45-60 minutes once a week for six weeks.
Following the training, a post-test will be administered to the life skills workshop group (Group 2).
|
Week 1: Introduction, defining group dynamics. Week 2: Physiological Relaxation (Progressive Relaxation Exercises) Week 3: Sleep Hygiene: Circadian Rhythm and Biological Clock, Melatonin and Light Relationship, Sleep Stages and Restorative Effect Week 4: Nutrition and Stress: The effect of nutrition on stress and anxiety will be discussed: Blood Sugar Balance and "False Anxiety" (Glycemic Index), Gut-Brain Axis and Serotonin, Caffeine and Cortisol Interaction. Week 5: Social Support and Problem Solving: Time Management and Academic Stress (Problem-Oriented Coping), Social Support and Oxytocin Effect, and Recreation and "Active Rest". Week 6: Program evaluation and closing.
Other Names:
|
|
No Intervention: GROUP 3: Control Group
A pre-test will be administered to all students before the training.
Students who agree to participate in the study and are randomly assigned to the control group will not receive any intervention for six weeks.
After the completion of the training for the other groups, a post-test will be administered to the control group (Group 3).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Information Form
Time Frame: At the end of the training, at the end of the 6th week
|
This form consists of eight questions asking participants to assess their age, gender, class, economic status, smoking/alcohol or substance use, place of residence, and health status.
|
At the end of the training, at the end of the 6th week
|
|
Mindful Attention Awareness Scale (MAAS)
Time Frame: At the end of the training, at the end of the 6th week
|
The Mindful Attention Awareness Scale is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life.
MAAS has a single-factor structure and gives a single total score.
High scores on the scale indicate high mindful awareness.
MAAS is a 6-point Likert-type scale (Almost always, most of the time, sometimes, rarely, quite rarely, almost never).
|
At the end of the training, at the end of the 6th week
|
|
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: At the end of the training, at the end of the 6th week
|
The scale uses a 4-point Likert-type rating scale (Never=0, Sometimes and Occasionally=1, Quite Often=2, Always=3).
The scale has three sub-dimensions: depression, anxiety, and stress.
Each sub-dimension consists of 7 items, for a total of 21 items.
The highest possible score is 21, and the lowest is 0. The normal range is 0-4 for depression, 0-3 for anxiety, and 0-7 for stress.
Mild depression scores range from 5-6, anxiety from 4-5, and stress from 8-9; moderate depression scores range from 7-10, anxiety from 6-7, and stress from 10-12; severe depression scores range from 11-13, anxiety from 8-9, and stress from 13-16; profound depression scores range from 14 and above, anxiety from 10 and above, and stress from 17 and above.
|
At the end of the training, at the end of the 6th week
|
|
WHO (Five) Well-being Index
Time Frame: At the end of the training, at the end of the 6th week
|
Developed to assess participants' well-being, this scale consists of a single dimension and 5 items, each scored on a 6-point Likert scale ranging from "never (0)" to "always (5)".
There are no reverse-coded items.
The raw score is calculated by summing the numbers from the five responses.
The raw score ranges from 0 to 25, where 0 represents the worst possible quality of life and 25 represents the best possible quality of life.
To obtain a percentage score between 0 and 100, the raw score is multiplied by 4. 0% indicates the worst possible quality of life, while 100% represents the best possible quality of life.
|
At the end of the training, at the end of the 6th week
|
|
Emotion Regulation Difficulty Scale-Short Form
Time Frame: At the end of the training, at the end of the 6th week
|
This scale is a 5-point Likert scale.
There are no reverse-coded items.
While the scale can be evaluated within the scope of sub-dimensions, high total scores indicate a greater degree of emotion regulation difficulty.
The scale consists of the following sub-dimensions: openness (items 1 and 2), goals (items 3, 7, and 15), drive (items 4, 8, and 11), strategies (items 5, 6, 12, 14, and 16), and rejection (items 9, 10, and 13).
|
At the end of the training, at the end of the 6th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ghawadra SF, Abdullah KL, Choo WY, Phang CK. Mindfulness-based stress reduction for psychological distress among nurses: A systematic review. J Clin Nurs. 2019 Nov;28(21-22):3747-3758. doi: 10.1111/jocn.14987. Epub 2019 Jul 22.
- Alkhawaldeh JM, Khawaldeh MA, Mrayyan MT, Yehia D, Shudifat RM, Anshasi HA, Al-Shdayfat NM, Alzoubi MM, Aqel A. The efficacy of mindfulness-based programs in reducing anxiety among nurses in hospital settings: A systematic review. Worldviews Evid Based Nurs. 2024 Aug;21(4):395-406. doi: 10.1111/wvn.12722. Epub 2024 Apr 2.
- Bartlett ML, Taylor H, Nelson JD. Comparison of Mental Health Characteristics and Stress Between Baccalaureate Nursing Students and Non-Nursing Students. J Nurs Educ. 2016 Feb;55(2):87-90. doi: 10.3928/01484834-20160114-05.
- Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
- Ceravolo D, Raines DA. The Impact of a Mindfulness Intervention for Nurse Managers. J Holist Nurs. 2019 Mar;37(1):47-55. doi: 10.1177/0898010118781620. Epub 2018 Jun 18.
- Coster S, Gould RL, Coulson M, Norman IJ. An online mindfulness intervention to enhance compassion in nursing practice: A feasibility and acceptability study with nursing students. Int J Nurs Stud Adv. 2020 Jun 14;2:100004. doi: 10.1016/j.ijnsa.2020.100004. eCollection 2020 Nov.
- Gotink RA, Meijboom R, Vernooij MW, Smits M, Hunink MG. 8-week Mindfulness Based Stress Reduction induces brain changes similar to traditional long-term meditation practice - A systematic review. Brain Cogn. 2016 Oct;108:32-41. doi: 10.1016/j.bandc.2016.07.001. Epub 2016 Jul 16.
- Karo M, Simorangkir L, Daryanti Saragih I, Suarilah I, Tzeng HM. Effects of mindfulness-based interventions on reducing psychological distress among nurses: A systematic review and meta-analysis of randomized controlled trials. J Nurs Scholarsh. 2024 Mar;56(2):319-330. doi: 10.1111/jnu.12941. Epub 2023 Nov 13.
- Kral TRA, Davis K, Korponay C, Hirshberg MJ, Hoel R, Tello LY, Goldman RI, Rosenkranz MA, Lutz A, Davidson RJ. Absence of structural brain changes from mindfulness-based stress reduction: Two combined randomized controlled trials. Sci Adv. 2022 May 20;8(20):eabk3316. doi: 10.1126/sciadv.abk3316. Epub 2022 May 20.
- McVeigh C, Ace L, Ski CF, Carswell C, Burton S, Rej S, Noble H. Mindfulness-Based Interventions for Undergraduate Nursing Students in a University Setting: A Narrative Review. Healthcare (Basel). 2021 Nov 2;9(11):1493. doi: 10.3390/healthcare9111493.
- Salvarani V, Ardenghi S, Rampoldi G, Bani M, Cannata P, Ausili D, Di Mauro S, Strepparava MG. Predictors of psychological distress amongst nursing students: A multicenter cross-sectional study. Nurse Educ Pract. 2020 Mar;44:102758. doi: 10.1016/j.nepr.2020.102758. Epub 2020 Mar 13.
- Suleiman-Martos N, Gomez-Urquiza JL, Aguayo-Estremera R, Canadas-De La Fuente GA, De La Fuente-Solana EI, Albendin-Garcia L. The effect of mindfulness training on burnout syndrome in nursing: A systematic review and meta-analysis. J Adv Nurs. 2020 May;76(5):1124-1140. doi: 10.1111/jan.14318. Epub 2020 Mar 4.
- Sundling V, Sundler AJ, Holmstrom IK, Kristensen DV, Eide H. Mindfulness predicts student nurses' communication self-efficacy: A cross-national comparative study. Patient Educ Couns. 2017 Aug;100(8):1558-1563. doi: 10.1016/j.pec.2017.03.016. Epub 2017 Mar 11.
- Tang YY, Tang R, Posner MI. Mindfulness meditation improves emotion regulation and reduces drug abuse. Drug Alcohol Depend. 2016 Jun 1;163 Suppl 1:S13-8. doi: 10.1016/j.drugalcdep.2015.11.041.
- Tomlinson ER, Yousaf O, Vitterso AD, Jones L. Dispositional Mindfulness and Psychological Health: a Systematic Review. Mindfulness (N Y). 2018;9(1):23-43. doi: 10.1007/s12671-017-0762-6. Epub 2017 Jul 1.
- Van Gordon W, Shonin E, Dunn TJ, Garcia-Campayo J, Griffiths MD. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. Br J Health Psychol. 2017 Feb;22(1):186-206. doi: 10.1111/bjhp.12224. Epub 2016 Nov 25.
- Yosep I, Mardhiyah A, Sriati A. Mindfulness Intervention for Improving Psychological Wellbeing Among Students During COVID-19 Pandemic: A Scoping Review. J Multidiscip Healthc. 2023 May 23;16:1425-1437. doi: 10.2147/JMDH.S411849. eCollection 2023.
- Yuksel A, Bahadir Yilmaz E. The effects of group mindfulness-based cognitive therapy in nursing students: A quasi-experimental study. Nurse Educ Today. 2020 Feb;85:104268. doi: 10.1016/j.nedt.2019.104268. Epub 2019 Nov 14.
Helpful Links
- Ardenghi, S., et al. 2023. "The association between dispositional mindfulness and empathy among undergraduate nursing students: A multicenter cross sectional study." Current Psychology, 42, 15132-15140.
- Chen, X., Zhang, B., Jin, S. X., Quan, Y. X., Zhang, X. W., Cui, X. S. 2021. "The effects of mindfulness-based interventions on nursing students: A meta-analysis", Nurse Education Today, 98(November 2020), 104718.
- Cura, S. U., Atay, S. 2023. "Correlation between mindfulness, empathy and compassion levels of nursing students: A cross-sectional study", Archives of Psychiatric Nursing, 42, 92-96. doi: 10.1016/j.apnu.2022.12.017
- Veigh, C. M., et al. 2021. "Mindfulness as a well-being initiative for future nurses: a survey with undergraduate nursing students", BMC Nursing. 20(1), 253.
- Wrenn, M.V. 2022. "Corporate mindfulness culture and neoliberalism", Review of Radical Political Economics, 54, 153-170.
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMU23
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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