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IRCT20260617069854N1 IRCT 2026-07-04 Islamic Azad University The effectiveness of mindfulness intervention on mental health and work-life balance of working women The effectiveness of a preventive self-care protocol based on mindfulness on reducing perceived stress and improving work-life balance in women working in hospital healthcare staff 2026-07-11 anticipated 50 Complete https://irct.ir/trial/91024 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population will include all women working in the medical staff in hospitals affiliated to the University of Medical Sciences during the specified time period. In the sample selection stage, the convenience sampling method will be used. After selecting a sample size of 50 people, based on the study's entry and exit criteria, participants will be randomly assigned to two groups: "Mindfulness-Based Self-Care Preventive Protocol" (intervention group) and "Waiting List" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). The envelope will be opened and the allocation group will be informed only when each participant enters the study. To ensure the equality of basic variables (such as anxiety level, age, and work experience), their distribution in the two groups will be examined during the statistical analysis stage. N/A Job burnout. Intervention 1: Intervention group: Mindfulness-based preventive self-care protocol. Duration of each session: 90 minutes. Total number of sessions: 8 sessions. Sequence of sessions: Twice a week. Therapeutic tools used: This intervention focuses on teaching and practicing mindfulness-based self-care skills with the aim of increasing present-moment awareness, reducing stress reactivity, regulating emotions, and enhancing work-life balance. The main tools used in this protocol include conscious breathing exercises, body scanning, mindfulness of thoughts and emotions, nonjudgmental acceptance, exercises to pay attention to the body and emotions, mindfulness exercises in daily activities, and rebuilding self-care behavioral patterns. The content of the various sessions is based on the following: Session 1: Pre-test implementation, introduction of the protocol, and explanation of the concepts of mindfulness and self-care. Session 2: Training in conscious breathing exercises and increasing attention to the present moment. Session 3: Training in the body scanning technique to identify and release physical tensions. Session 4: Training in observing thoughts without judgment and managing emotional reactions. Session 5: Training in the skill of accepting and managing stress in difficult situations. Session 6: Practicing mindfulness in daily activities and the workplace (treatment staff). Session 7: Developing self-care strategies to improve work-life balance. Session 8: Conclusion, providing final suggestions, conducting a post-test, and determining the follow-up time. Intervention 2: Control group: The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the lack of completion of the research work and the failure to write the article, which is a requirement for publishing the data, I will publish the data as soon as the aforementioned issues are resolved.
public Maryam Duraki
No. 59, Kajbaf 2 Street, Zamin Shahri Residential Complex, Negahbani three-way, Bahonar
Ahvaz Iran (Islamic Republic of) 6176865187 +98 61 3333 3333 maryam.doraki@iau.ir Islamic Azad University scientific Maryam Duraki
No. 59, Kajbaf 2 Street, Zamin Shahri Residential Complex, Negahbani three-way, Bahonar
Ahvaz Iran (Islamic Republic of) 6176865187 +98 61 3333 3333 maryam.doraki@iau.ir Islamic Azad University Iran (Islamic Republic of) Women working in healthcare Achieving a score above average on the perceived stress questionnaire Having at least 1 year of clinical experience in a hospital 25 years 35 years Female Participation in similar mindfulness or yoga courses in the last 6 months Unwillingness to attend meetings Z73.0 Burn-out Treatment - Other Treatment - Other Intervention group: Mindfulness-based preventive self-care protocol. Duration of each session: 90 minutes. Total number of sessions: 8 sessions. Sequence of sessions: Twice a week. Therapeutic tools used: This intervention focuses on teaching and practicing mindfulness-based self-care skills with the aim of increasing present-moment awareness, reducing stress reactivity, regulating emotions, and enhancing work-life balance. The main tools used in this protocol include conscious breathing exercises, body scanning, mindfulness of thoughts and emotions, nonjudgmental acceptance, exercises to pay attention to the body and emotions, mindfulness exercises in daily activities, and rebuilding self-care behavioral patterns. The content of the various sessions is based on the following: Session 1: Pre-test implementation, introduction of the protocol, and explanation of the concepts of mindfulness and self-care. Session 2: Training in conscious breathing exercises and increasing attention to the present moment. Session 3: Training in the body scanning technique to identify and release physical tensions. Session 4: Training in observing thoughts without judgment and managing emotional reactions. Session 5: Training in the skill of accepting and managing stress in difficult situations. Session 6: Practicing mindfulness in daily activities and the workplace (treatment staff). Session 7: Developing self-care strategies to improve work-life balance. Session 8: Conclusion, providing final suggestions, conducting a post-test, and determining the follow-up time. Control group: The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization. Perceived stress. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be the Cohen et al. (1983) Perceived Stress Scale. Work-life balance. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be using the Fisher et al. (2009) work-life balance questionnaire. Islamic Azad University Approved 2026-06-16 Ethics Committee of Islamic Azad University of Ahvaz Branch Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)