Protocol summary

Study aim
Investigating the effect of Mindfulness-Based Stress Reduction (MBSR) Programs on Cognitive Flexibility and Occupational Resilience in Critical Care Nurses
Design
This is a randomized clinical trial with a parallel design and control group. This randomized,non-blinded study will be conducted on 60 eligible nurses. A simple random method will be used for randomization and participants will be assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Shahid Beheshti Hospital in Kashan, is non-blinded. Before the study begins, the objectives of the study and how to answer the questions will be explained, then the questionnaires will be provided to the nurses.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Working nurses; Having at least 6 months of work experience as a nurse in special wards Exclusion criteria: History of chronic physical illness; History of acute mental disorders; Participation in similar mindfulness courses in the past 6 months; Receiving mood-regulating medications in the past 3 months
Intervention groups
The intervention group will receive mindfulness training in 8 sessions of 60 to 90 minutes (2 sessions per week with a minimum of two days between sessions). The first session will be in person, 6 sessions will be virtual through an online group in cyberspace, and the last session will be in person. The control group will not receive any intervention and will only be provided with a stress management pamphlet from the Ministry of Health.
Main outcome variables
Occupational Resilience, Cognitive Flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250825067000N1
Registration date: 2026-01-29, 1404/11/09
Registration timing: prospective

Last update: 2026-01-29, 1404/11/09
Update count: 0
Registration date
2026-01-29, 1404/11/09
Registrant information
Name
Najmeh Keyvannezhad
Name of organization / entity
Islamic Azad University, Isfahan (Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 5543 2016
Email address
keyvan2052@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-14, 1404/11/25
Expected recruitment end date
2026-04-14, 1405/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Mindfulness-Based Stress Reduction Programs on Cognitive Flexibility and Occupational Resilience in nurses
Public title
The effect of Mindfulness on Cognitive Flexibility and Occupational Resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Working nurses Having at least 6 months of work experience as a nurse in special wards
Exclusion criteria:
History of chronic physical illness History of acute mental disorders Participation in similar mindfulness courses in the past 6 months Taking mood-regulating medications in the last 3 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 60 cards are selected and numbers from 1-60 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
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, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2025-07-22, 1404/04/31
Ethics committee reference number
IR.IAU.KHUISF.REC.1404.361

Health conditions studied

1

Description of health condition studied
Cognitive Flexibility
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Occupational Resilience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive flexibility
Timepoint
Beginning of the study, end of the study (week four), four weeks after the end of the study (week eight)
Method of measurement
Using the Cognitive Flexibility Questionnaire

2

Description
Occupational Resilience
Timepoint
Beginning of the study, end of the study (week four), four weeks after the end of the study (week eight)
Method of measurement
Base on Occupational Resilience Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive mindfulness training in 8 sessions of 60 to 90 minutes (2 sessions per week with a minimum of two days between sessions). The first session will be in person, 6 sessions will be virtual through an online group in cyberspace, and the last session will be in person. The intervention includes: focusing and awareness of thoughts, emotions, and bodily sensations. Paying attention to a new way in the moment and without judgment, practicing seeing and listening in a non-judgmental way. Better recognition and acceptance of thoughts and feelings. Self-regulation and the use of effective problem-solving techniques. Increasing useful activities and regulating emotions.
Category
Treatment - Other

2

Description
The control group will not receive any intervention and will only be provided with a stress management pamphlet from the Ministry of Health.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Najmeh Keyvannezhad
Street address
5th km., Qotb Rawandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0028
Email
keyvan2052@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Web page address
https://isfahan.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Najmeh Keyvannezhad
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4003
Email
keyvan2052@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Narges Sadeghi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4003
Email
n.sadeghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Nares Sadeghi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4003
Email
n.sadeghi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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