Protocol summary

Study aim
Determining the effectiveness of Mindful Self-Compassion therapy on fatigue, emotional regulation, and self-critical rumination in nurses with burnout
Design
This clinical trial study is a controlled, parallel-group, unblinded, and randomized (sealed envelope) study. It was conducted on 30 nurses working in Aftab and Parsian hospitals who scored at least 66 on the burnout questionnaire. It includes a control group and an intervention group that participate in mindfulness self-compassion therapy sessions, and then the results of the questionnaire are evaluated.
Settings and conduct
30 eligible people are randomly placed in two experimental and control groups (15 people). Both groups will complete a pre-test; the experimental group will receive 8 sessions of mindful self-compassion therapy and 1 session of retreat (165 minutes), while the control group will receive no treatment. Finally, both groups will complete a post-test.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Minimum score of 66 on the Maslach and Jackson Burnout Inventory (1981); Meeting burnout diagnostic criteria according to ICD-11 and structured clinical interview; No concurrent psychiatric disorder (DSM-5); No concurrent acute or chronic physical illness; Not receiving any other psychological treatment simultaneously; Exclusion Criteria: Nurses with less than one year of work experience
Intervention groups
Control group: 15 eligible nurses who complete the research questionnaires as a pre-test but do not receive any treatment. Intervention group: 15 eligible nurses who, after the pre-test, participate in 8 sessions of mindfulness self-compassion therapy based on the Neff and Grammer(2013)protocol and1 session of retreat for165 minutes.
Main outcome variables
Mental Fatigue, Emotional Regulation, Self-Critical Rumination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250709066425N1
Registration date: 2025-08-14, 1404/05/23
Registration timing: prospective

Last update: 2025-08-14, 1404/05/23
Update count: 0
Registration date
2025-08-14, 1404/05/23
Registrant information
Name
Maedeh Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 2783
Email address
maedeh.safdari@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-12, 1404/06/21
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindful Self-Compassion Therapy on Mental Fatigue, Emotion Regulation, and Self-Critical Rumination in Nurses with Job Burnout
Public title
The effectiveness of mindfulness self-compassion therapy on Mental Fatigue, Emotional Regulation, and Self-Critical Rumination
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining a minimum score of 66 to diagnose burnout from the Maslach and Jackson (1981) questionnaire Having the necessary criteria for diagnosing burnout according to (ICD-11) based on a structured interview with a clinical psychologist Absence of diagnosable psychiatric disorders based on diagnostic criteria (DSM-5) and concurrent absence of acute physical illness No concurrent chronic physical illnesses Not receiving any other psychological treatment at the same time
Exclusion criteria:
Nurses with less than one year of work experience
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Experimental and control groups: After selecting the sample, in the next step, people are divided into experimental and control groups using a random method. How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from 1 to 30 are assigned to people). Second step: From these people, using a random method using sealed and opaque (numbered) envelopes, people are divided into two experimental groups and a control group. Each person randomly selects an envelope and is divided into the corresponding 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
Research Ethics Committees of Islamic Azad University - Varamin-Pishva Branch
Street address
Islamic Azad University, Varamin–Pishva Branch, Naghsh-e Jahan Town, Pishva County, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
7489533817
Approval date
2025-06-10, 1404/03/20
Ethics committee reference number
IR.IAU.VARAMIN.REC.1404.033

Health conditions studied

1

Description of health condition studied
Burn-out
ICD-10 code
Z73.0
ICD-10 code description
Burn-out

Primary outcomes

1

Description
Mental Fatigue
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Mental Fatigue Questionnaire Johnson et al. 2010

2

Description
Emotion Regulation
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Emotion Regulation Questionnaire Cross and John 2003

3

Description
Self-Critical Rumination
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Self-Critical Rumination Questionnaire Smart et al. 2016

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the control group. They will complete the Mental Fatigue, Emotion Regulation, and Self-Critical Rumination Questionnaire; however, no treatment will be administered to this group.
Category
Behavior

2

Description
Intervention group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the intervention group. They will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a pre-test, then undergo 8 sessions of mindfulness-based self-compassion therapy based on the Neff and Grammer (2013) method, as well as 1 session of seclusion, each session lasting 165 minutes. After completing the sessions, they will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a post-test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Aftab Eye Hospital
Full name of responsible person
Mahmoud Jabbarvand
Street address
Aftab Eye Hospital, Opposite Javanmardan Park, After Kan Bridge, Hemmat Expressway (West), Tehran, Iran ا
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 4614 3300
Email
info@aftabhospital.com

2

Recruitment center
Name of recruitment center
Parsian Hospital
Full name of responsible person
Mohammad Gili
Street address
Parsian Super Specialty Hospital, Farhang Square, East Sarv Street, Saadat Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2209 7151
Email
info@parsianhospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad University, South Tehran Branch
Full name of responsible person
Razieh Farazkish
Street address
7th Floor, Islamic Azad University, South Tehran Branch Building, Corner of Azarshahr St. and Iranshahr St., Karimkhan Zand St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1584715414
Phone
+98 21 8883 3104
Email
research@azad.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University, South Tehran 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
Full name of responsible person
Maede Safdari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 33, Shahid Shahbazpour Alley, Najafzadeh Foroutan Street, Ayatollah Kashani Boulevard, 2nd Sadeghieh Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1471685811
Phone
+98 919 896 9762
Email
maedesafdari7878@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Salarirad
Position
Associate professor, South Tehran Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Valiasr College, South Tehran Branch, Next to Bouali Hospital, Beginning of Damavand Street, Imam Hossein Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936855875
Phone
009822801448
Email
salariradz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maede Safdari
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 33, Shahid Shahbazpour Alley, Najafzadeh Foroutan Street, Ayatollah Kashani Boulevard, 2nd Sadeghieh Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1471685811
Phone
+98 919 896 9762
Email
maedesafdari7878@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 4 months after the results are published and after personally identifiable information is removed.
To whom data/document is available
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.
Under which criteria data/document could be used
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.
From where data/document is obtainable
f you need data, please contact maedesafdari7878@gmail.com
What processes are involved for a request to access data/document
After receiving and reviewing the request from the researcher, a response will be provided as soon as possible.
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