Protocol summary

Study aim
This study aims to evaluate the effect of a spiritual health intervention on job burnout and safe nursing care among nurses employed in the intensive care units of educational hospitals of Shahrekord University of Medical Sciences in 2025-2026
Design
This study is a randomized, controlled, parallel-group clinical trial conducted among 80 nurses working in intensive care units. Randomization of participants will be performed using a dice-rolling method.
Settings and conduct
The sample will consist of 80 nurses working in intensive care units (ICUs), selected through convenience sampling and randomly assigned to either the intervention or control group. Initially, all participants will complete the study questionnaires. The control group will then receive routine training, while the intervention group will undergo a spiritual health intervention program based on the Sound Heart model, conducted as five 90-minute group sessions held in the classrooms of Ayatollah Kashani and Hajar Hospitals in Shahrekord over five consecutive weeks. Finally, one month and three months after the intervention, both groups will again complete the questionnaires.
Participants/Inclusion and exclusion criteria
1. Written informed consent for participation in the study must be provided by the participants. 2. Nurses must have at least one year of work experience in intensive care units. 3. Participants must not have a prior history of attending any specific training programs related to the sound heart model of spiritual care. 4. A minimum of a Bachelor's degree in Nursing is mandatory for study participants.
Intervention groups
The intervention group will participate in a five-session educational program on spiritual health, based on the Sound Heart model. In contrast, the control group will receive only the standard routine training provided by the hospital.
Main outcome variables
Job burnout, Safe nursing care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240806062674N2
Registration date: 2025-09-18, 1404/06/27
Registration timing: prospective

Last update: 2025-09-18, 1404/06/27
Update count: 0
Registration date
2025-09-18, 1404/06/27
Registrant information
Name
Farshad Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
heidari.f@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual Health Intervention on Safe Nursing Care and Job Burnout of Nurses of Intensive Care Units
Public title
The Effect of Spiritual Health Intervention on Safe Nursing Care and Job Burnout of Nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Written informed consent for participation in the study must be provided by the participants.2. Nurses must have at least one year of work experience in intensive care units..3. A minimum of a Bachelor's degree in Nursing is mandatory for study participants.
Exclusion criteria:
3. Participants must not have a prior history of attending any specific training programs related to sound heart spiritual care
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sample randomization in this study will be conducted using a dice-rolling method. For this purpose, the researcher will assign odd numbers (i.e., 1, 3, and 5) to the control group and even numbers (i.e., 2, 4, and 6) to the intervention group. Then, after obtaining informed consent, the researcher will roll the dice and assign the participant to either the control or test group as described. This process will continue until the calculated sample size is reached for both groups.
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
Research Ethics Committees of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2025-05-20, 1404/02/30
Ethics committee reference number
IR.SKUMS.REC.1404.036

Health conditions studied

1

Description of health condition studied
nurses working in Intensive Care Units
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of Job Burnout in the Maslach Burnout Inventory (MBI)
Timepoint
Before, one month, and three months after the intervention.
Method of measurement
The Maslach Burnout Inventory (MBI) is the most widely used instrument for assessing occupational burnout in individuals with diverse job and professional backgrounds. This questionnaire consists of 22 items scored on a Likert scale from 0 (never) to 6 (very often) and includes three subscales: emotional exhaustion, depersonalization, and personal accomplishment. The total score ranges from 0 to 132, with higher scores indicating greater burnout severity.

Secondary outcomes

1

Description
The score obtained from the Safe Nursing Care Tool in the Intensive Care Unit
Timepoint
Before the intervention, one month after the intervention, and three months after the intervention
Method of measurement
To assess safe nursing care, the Safe Nursing Care Tool in the Intensive Care Unit, designed and validated by Tajri et al. (2024), will be used. This instrument consists of 42 items across four subscales: Professional behavior through adherence to guidelines, Comprehensive care, Accurate documentation, Pressure ulcer care. The items are scored on a 5-point Likert scale. Given the 42 items, the total possible score ranges from a minimum of 42 (if a respondent answers "Never" to all items) to a maximum of 210 (if a respondent answers "Always" to all items). A higher total score indicates a higher level of safe nursing care provided.

Intervention groups

1

Description
Intervention group: The intervention group will receive a spiritual health intervention program based on the Sound Heart model. This program covers topics such as: building rapport and trust, enhancing spiritual knowledge, coping and adaptation, developing self-connection, strengthening connection with God, fostering social relationships, drawing inspiration from creation, motivation and values, and behavioral intention and self-control. The content will be delivered in five weekly 90-minute group sessions held in hospital classrooms. Each session will begin with a 20-minute review of the previous material, followed by the presentation of new content. The educational material is based on the Spiritual Health Guidebook for Students and Healthcare Staff. To ensure follow-up and address participants’ questions, members of the intervention group will be added to a WhatsApp group created by the researcher, who will remain available for support and clarification throughout the program
Category
Behavior

2

Description
Control group: Nurses employed in intensive care units assigned to the control group will receive only the routine training provided by the hospitals and will not participate in any additional educational programs.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital of Shahrekord
Full name of responsible person
Farshad Heidari
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir
Web page address
https://en.skums.ac.ir/page-enmain/en/0/form/pId22978

2

Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Farshad Heidari
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Akbar Soleimani
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Farshad Heidari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
:۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Heidari.f@skums.cir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hedayatollah Lalegani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
lalehganihedayat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farshad Heidari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0062
Email
Heidari.f@skums.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
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
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
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