Determining the impact of moral case deliberation on the perception of futile care and moral distress in nurses
Design
The present study is a randomized controlled clinical trial that will be conducted with the participation of 60 nurses working in the ICU wards of Imam Reza and Ghaem hospitals in Mashhad, with double-blind, parallel groups, phase 2.
Settings and conduct
For the MCD intervention group, the program will be conducted over three weekly sessions with groups of ten ICU nurses from Ghaem and Imam Reza hospitals in Mashhad; the first session will be held in person, while the second and third sessions will take place virtually (via Skyroom). For the control group, educational content regarding ethical considerations in intensive care will be made available online. Participants in both the intervention and control groups will complete the Soleimani Moral Distress Questionnaire and the Mohammadi Perceived Futile Care Questionnaire at three time points: prior to the intervention, immediately after the final MCD session, and two weeks following that session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, having at least six months of work experience in the intensive care unit, and currently working in the intensive care unit at the time of the study.
Exclusion criteria: Unwillingness to continue participating in the study and missing at least one MCD session.
Intervention groups
In the MCD intervention group, which includes end-of-life care cases and patients in a vegetative state, it will be carried out in ten stages. In the control group, educational content related to ethical considerations in the intensive care unit will be uploaded.
Main outcome variables
Moral distress, perception of futile care
General information
Reason for update
Acronym
MCD
IRCT registration information
IRCT registration number:IRCT20260622069909N1
Registration date:2026-07-12, 1405/04/21
Registration timing:prospective
Last update:2026-07-12, 1405/04/21
Update count:0
Registration date
2026-07-12, 1405/04/21
Registrant information
Name
Elham Raoufi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6730
Email address
raoufie4031@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determinate the effect of Moral Case Deliberation on understanding futile care and moral distress in nurses
Public title
The effect of an ethical intervention on the perception of futile care and moral distress in nurses.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having consent to participate in the study
At least six months of work experience in an intensive care unit.
Working in the intensive care unit at the time of the study
Exclusion criteria:
Unwillingness to continue participating in the research
Failure to attend at least one MCD meeting
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a clustered permuted-block method will be used to generate the random allocation sequence for assigning ICU centers to the study groups. The random allocation sequence for individuals will be generated using Random Allocation Software with random block sizes. Sealed envelopes will be used for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study units will be selected using a convenience sampling method based on inclusion and exclusion criteria.
A total of eight ICU units from two hospitals will be included in the study, with four units selected from each hospital via convenience sampling. Within each hospital, two ICU units will be assigned to the intervention group and two to the control group. Randomization of the ICU units within each hospital will be conducted separately using permuted blocks. The random allocation sequence will be generated using "Random Allocation Software" with random block sizes.To ensure allocation concealment, the allocation sequence will be placed in opaque, sealed, and numbered envelopes, such that those administering the intervention remain unaware of the group assigned to the ICU sections until the intervention is actually performed.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۸۹۹۱۹۱
Approval date
2026-06-17, 1405/03/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1405.031
Health conditions studied
1
Description of health condition studied
Understanding futile care
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Moral distress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score derived from Mohammadi's Futile Care Perception Questionnaire
Timepoint
Before the intervention, immediately, and two weeks after the end of the last MCD session
Method of measurement
Mohammadi's perception of futile care questionnaire
2
Description
The score derived from the Soleimani Moral Distress Questionnaire
Timepoint
Before the intervention, immediately, and two weeks after the end of the last MCD session
Method of measurement
Soleimani's moral distress questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
MCD will be implemented in the intervention group. Prior to the intervention, to ensure consistency across groups regarding the ethical cases presented, the research team will compile a list of ethical scenarios—such as end-of-life care and patients in a vegetative state—tailored to the ICU setting and the study objectives; these scenarios will be reviewed and validated by experts. Subsequently, one ethical scenario will be selected for presentation during each MCD session. Based on prior research, the MCD intervention will be conducted over three sessions, spaced one week apart. The sessions will be held with groups of ten nurses.The sessions will be structured such that the first session is held in person, while the second and third sessions take place virtually (via the Skyroom platform). Based on prior research, the duration of each in-person session will be between one and one-and-a-half hours. The MCD team will consist of a coordinator and two facilitators with expertise in nursing ethics concepts. Drawing on previous studies, the MCD intervention will be implemented across ten stages during each session.
Category
Behavior
2
Description
Control group: For the control group, educational content regarding ethical considerations in intensive care will be provided. Prior to the intervention, this content will be developed based on an extensive review of relevant literature and consultation with specialists and experts; it will then be submitted to seven faculty members and specialists for review and feedback on its quality. Subsequently, the resulting suggestions will be evaluated and incorporated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU units at Imam Reza Hospital in Mashhad
Full name of responsible person
Elham Raoufi
Street address
Edge of Imam Reza Square, Ibn Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
raoufie4031@mums.ac.ir
2
Recruitment center
Name of recruitment center
ICU Units at Ghaem Hospital, Mashhad
Full name of responsible person
Elham Raoufi
Street address
Ghaem Educational, Research, and Treatment Center, Ahmadabad Street, Dr. Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Office of Research and Technology, Ghoreyshi Building, Next to Hoveyzeh Cinema, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Phone
+98 51 3841 2081
Email
IRH.CRU@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Elham Raoufi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Email
Raoufie4031@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayereh Davoudi Hasan Abad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Email
DavoudiN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Raoufi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Email
Raoufie4031@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available