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
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.
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 50 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population will include all the women working in the medical staff in the affiliated hospitals of Ahvaz University of Medical Sciences in the specified time period. In the sample selection stage, available sampling method is used. After selecting the samples to the size of 50 people, based on the research entry and exit criteria, the participants will be randomly assigned to two groups: "preventive self-care protocol based on mindfulness" (intervention group) and "waiting list" (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women working in healthcare, having at least 1 year of clinical experience in a hospital, scoring above average on the perceived stress questionnaire.
Exclusion criteria: Participation in similar mindfulness or yoga courses in the last 6 months, unwillingness to participate in sessions.
Intervention groups
Intervention group: receiving the mindfulness-based self-care preventive intervention;
Control group: not receiving any intervention.
Main outcome variables
Perceived stress, Work-life balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260617069854N1
Registration date:2026-07-04, 1405/04/13
Registration timing:prospective
Last update:2026-07-04, 1405/04/13
Update count:0
Registration date
2026-07-04, 1405/04/13
Registrant information
Name
Maryam Doraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
maryam.doraki@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-11, 1405/04/20
Expected recruitment end date
2026-07-27, 1405/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effectiveness of mindfulness intervention on mental health and work-life balance of working women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Participation in similar mindfulness or yoga courses in the last 6 months
Unwillingness to attend meetings
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz Branch
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.