NCT07544355

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable depression

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

MindfulnessNursing StudentsMindful Awareness

Outcome Measures

Primary Outcomes (5)

  • 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.

    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).

    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.

    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.

    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).

    At the end of the training, at the end of the 6th week

Study Arms (3)

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).

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).

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).

Interventions

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.

Also known as: (Group 1)
The mindfulness group-Mindfulness-Based Stress Reduction Program (Group 1)

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.

Also known as: (Group 2)
The life skills workshop group-Lifestyle Management and Well-being Workshop (Group 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Central Study Contacts

Rujnan Tuna, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Participants will be informed that all data collected will remain confidential and will not be shared with anyone.