The effect of implementing mindfulness exercises on moral distress among nurses working in the intensive care units of Imam Reza educational and medical center in Larestan in 2025
Design
A clinical trial with two groups (intervention and control) will be conducted on 56 participants who are selected using convenience sampling. Using a random number table, the participants will be randomly assigned to either the intervention group or the control group.
Settings and conduct
The study will be conducted in the intensive care units of Imam Reza Educational and Medical Center in Larestan. The study population consists of 56 nurses. Blinding type: No blinding will be applied in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Holding a bachelor's degree or higher; ability to attend all sessions; having at least 6 months of work experience in intensive care units. Exclusion criterion: Simultaneous participation in an intervention program during the implementation of the research
Intervention groups
Intervention group: After completing the questionnaires, participants will take part in eight 60-minute mindfulness training sessions based on the Kabat-Zinn model. The sessions include mindful breathing, body scan, meditation, mindful movement, and non-judgmental awareness.
Control group:The control group will not receive any intervention.
Main outcome variables
Moral distress score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251028067796N1
Registration date:2025-12-12, 1404/09/21
Registration timing:prospective
Last update:2025-12-12, 1404/09/21
Update count:0
Registration date
2025-12-12, 1404/09/21
Registrant information
Name
Hamidreza Ghavami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 4549
Email address
hamid.r.gh.1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-16, 1404/09/25
Expected recruitment end date
2025-12-30, 1404/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness exercises on moral distress among nurses working in the intensive care units
Public title
The effect of mindfulness exercises on moral distress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a bachelor's degree or higher
Ability to attend all meetings
Having at least 6 months of work experience in the intensive care unit (ICU)
Exclusion criteria:
Simultaneous participation in an intervention program during the implementation of the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing the list of eligible nurses and assigning a unique number to each individual, the randomization process was carried out using a random number table. A starting point in the table was first selected at random. Then, the numbers in the table were read sequentially, and each number was assigned to one of the two groups based on whether it was even or odd; even numbers were allocated to the control group and odd numbers to the intervention group. Numbers that fell outside the range of assigned codes were ignored, and the reading continued until the required sample size was achieved.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah Boulevard, Arghavaniyeh, East J Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
743183886
Approval date
2025-09-07, 1404/06/16
Ethics committee reference number
IR.IAU.KHUISF.REC.1404.496
Health conditions studied
1
Description of health condition studied
Moral distress among nurses working in the intensive care units
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The moral distress score in the Hamric questionnaire
Timepoint
Before the intervention and immediately after the completion of the intervention sessions
Method of measurement
Hamric Moral Distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the intervention group. Then, the intervention will be implemented as an in-service training program titled “Mindfulness Exercises Training,” consisting of 7 to 8 in-person sessions of 60 minutes each (using PowerPoint presentations). The session content includes mindfulness exercises based on Jon Kabat-Zinn’s model (mindful breathing, body scan, sitting meditation, mindful movement, awareness of the present moment in daily activities, acceptance, and non-judgment). After completing the sessions, the Moral Distress Questionnaire will be administered again to the intervention group, and the results of the intervention and control groups will be compared and evaluated.
Category
Behavior
2
Description
Control group: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the control group. After the intervention is completed, the educational content provided to the intervention group will also be presented to the control group in order to observe ethical considerations and allow these participants to benefit from the in-service training program as well.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational and Medical Center, Laristan
Full name of responsible person
Hamidreza Ghavami
Street address
Imam Reza Educational and Medical Center, Dr. Dadman Highway
City
Larestan
Province
Fars
Postal code
7431843886
Phone
+98 71 5224 2101
Fax
+98 71 5224 2107
Email
larhosp@larums.ac.ir
Web page address
https://emamreza.larums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Shajari
Street address
Islamic Azad University Complex, Shohada-ye Gomnam Boulevard, Alam Square, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 6781
Fax
+98 35 3821 5034
Email
sohajfr990@gmail.com
Web page address
https://B2n.ir/ks6734
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Full name of responsible person
hamidreza ghavami
Position
Master’s degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yazd, Safaieh, Alam Square, Islamic Azad University Complex
City
yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 6781
Fax
Email
hamid.r.gh.1998@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoumeh Barkhordari Sharif Abadi
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yazd, Safaieh, Alam Square, Shohada-ye Gomnam Boulevard, Islamic Azad University Complex
City
yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 6781
Fax
+98 35 3821 5034
Email
barkhordary_m@yahoo.com
Web page address
https://yazd.iau.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
hamidrezaghavami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University Complex, Shohada-ye Gomnam Boulevard, Alam Square, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 0540 3821
Email
hamid.r.gh.1998@gmail.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