DepressionNCT07544355
A Mindfulness-Based Stress Reduction Training Program Model
A study testing The mindfulness group-"Mindfulness-Based Stress Reduction Program" and The life skills workshop group-"Lifestyle Management and Well-being Workshop" in people with Depression and Anxiety, run by Istanbul Medeniyet University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- The mindfulness group-"Mindfulness-Based Stress Reduction Program" and The life skills workshop group-"Lifestyle Management and Well-being Workshop"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression, Anxiety, Stress, Well-Being, Psychological
- Being tested
- The mindfulness group-"Mindfulness-Based Stress Reduction Program", The life skills workshop group-"Lifestyle Management and Well-being Workshop"
- Keywords
- Mindfulness, Nursing Students, Mindful Awareness
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mindfulness group-"Mindfulness-Based Stress Reduction Program"Behavioural
Also called (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.
The life skills workshop group-"Lifestyle Management and Well-being Workshop"Behavioural
Also called (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.
| Study group | Role | What they receive |
|---|---|---|
| The mindfulness group-Mindfulness-Based Stress Reduction Program (Group 1) | Experimental | 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). Receives: Behavioral: The mindfulness group-"Mindfulness-Based Stress Reduction Program" |
| The life skills workshop group-Lifestyle Management and Well-being Workshop (Group 2) | Placebo comparator | 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). Receives: Behavioral: The life skills workshop group-"Lifestyle Management and Well-being Workshop" |
| GROUP 3: Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Participant Information Form
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.
Measured: At the end of the training, at the end of the 6th week
Mindful Attention Awareness Scale (MAAS)
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).
Measured: At the end of the training, at the end of the 6th week
Depression, Anxiety, Stress Scale (DASS-21)
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.
Measured: At the end of the training, at the end of the 6th week
WHO (Five) Well-being Index
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.
Measured: At the end of the training, at the end of the 6th week
Emotion Regulation Difficulty Scale-Short Form
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).
Measured: At the end of the training, at the end of the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nursing students who agree to participate in the study, complete the pre-test, have no psychological disorders, have not previously received mindfulness training, and have a pre-test stress score above normal will be included in the research sample using purposive sampling. Randomization of the intervention and control groups will be performed randomly by computer.
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rujnan Tuna, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544355
- Sponsor's protocol ID
- IstanbulMU23
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be informed that all data collected will remain confidential and will not be shared with anyone.
Publications
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.
PubMed 38563435Bartlett 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.
PubMed 26814818Black 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.
PubMed 26799456Ceravolo 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.
PubMed 29909707Coster 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.
PubMed 38745902Ghawadra 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.
PubMed 31267619Gotink 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.
PubMed 27429096Karo 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.
PubMed 37955233Kral 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.
PubMed 35594344McVeigh 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.
PubMed 34828538Salvarani 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.
PubMed 32234667Suleiman-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.
PubMed 32026484Sundling 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.
PubMed 28342674Tang 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.
PubMed 27306725Tomlinson 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.
PubMed 29387263
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Stress Reduction Training Program Model for Empowering Nursing Students
- ClinicalTrials.gov ID
- NCT07544355
- Acronym / sponsor ID
- IstanbulMU23
- Conditions
- Depression, Anxiety, Stress, Well-Being, Psychological
- Keywords
- Mindfulness, Nursing Students, Mindful Awareness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Nursing students who agree to participate in the study, complete the pre-test, have no psychological disorders, have not previously received mindfulness training, and have a pre-test stress score above normal will be included in the research sample using purposive sampling. Randomization of the intervention and control groups will be performed randomly by computer.
| Arm | Type | Receives |
|---|---|---|
| The mindfulness group-Mindfulness-Based Stress Reduction Program (Group 1) | Experimental | Behavioral: The mindfulness group-"Mindfulness-Based Stress Reduction Program"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). |
| The life skills workshop group-Lifestyle Management and Well-being Workshop (Group 2) | Placebo comparator | Behavioral: The life skills workshop group-"Lifestyle Management and Well-being Workshop"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). |
| GROUP 3: Control Group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| The mindfulness group-"Mindfulness-Based Stress Reduction Program"Also: (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. | Behavioural | The mindfulness group-Mindfulness-Based Stress Reduction Program (Group 1) |
| The life skills workshop group-"Lifestyle Management and Well-being Workshop"Also: (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. | Behavioural | The life skills workshop group-Lifestyle Management and Well-being Workshop (Group 2) |
Primary outcome
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.
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).
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 38563435Alkhawaldeh 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.
- Results publication: PubMed 26814818Bartlett 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.
- Results publication: PubMed 26799456Black 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.
- Results publication: PubMed 29909707Ceravolo 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.
- Results publication: PubMed 38745902Coster 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.
- Results publication: PubMed 31267619Ghawadra 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.
- Results publication: PubMed 27429096Gotink 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.
- Results publication: PubMed 37955233Karo 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.
- Results publication: PubMed 35594344Kral 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.
- Results publication: PubMed 34828538McVeigh 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.
- Results publication: PubMed 32234667Salvarani 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.
- Results publication: PubMed 32026484Suleiman-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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.2022.12.017Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Wrenn, M.V. 2022. "Corporate mindfulness culture and neoliberalism", Review of Radical Political Economics, 54, 153-170.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Participants will be informed that all data collected will remain confidential and will not be shared with anyone.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The mindfulness group-"Mindfulness-Based Stress Reduction Program" and The life skills workshop group-"Lifestyle Management and Well-being Workshop" in people with Depression and Anxiety, run by Istanbul Medeniyet University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rujnan Tuna, PhD (+902162803153, rujnantuna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Information Form (time frame: At the end of the training, at the end of the 6th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544355, which also lists 18 linked publications.
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 Apr 2026.