History
# Registration date Revision Id
2 2024-08-22, 1403/06/01 313163
1 2024-08-10, 1403/05/20 310971
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  • Recruitment centers

    #1
    Name of recruitment center - English: Emam Zaman
    Name of recruitment center - Persian: امام زمان
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Street address - English: Mosala street
    Street address - Persian: خیابان مصلی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 0000000
    Phone: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
    Name of recruitment center - English: Clinic
    Name of recruitment center - Persian: کلینیک
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Street address - English: No. 52, Rahnamaei 14, Rahnamaei blv.
    Street address - Persian: راهنمایی۱۴، پلاک ۵۲
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Street address - English: Rahnamaei blv., Rahnamaei 14, No. 52
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Personal
    Name of organization / entity - Persian: خصوصی
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Street address - English: No. 52, Rahnamaei 14, Rahnamaei blv.
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rahnamaei blv., Rahnamaei 14, No. 52
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 52, Rahnamaei 14, Rahnamaei blv.
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rahnamaei blv., Rahnamaei 14, No.52
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.52, Rahnamaei 14, Rahnamaei blv.
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rahnamaei blv., Rahnamaei 14, No. 52
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Minoo Shafi'niya
    Full name of responsible person - Persian: مینو شفیع نیا
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 52, Rahnamaei 14, Rahnamaei blv.
    Street address - Persian: راهنمایی ۱۴، پلاک ۵۲، واحد ۳
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9185654355
    Phone: +98 51 3847 1163
    Mobile: +98 990 019 9778
    Fax:
    Email: msihnaofoi@gmail.com
    Web page address:

Protocol summary

Study aim
Examining the Effect of Mindful Self-Compassion Therapy on Reducing Psychological Distress and Burnout in Nurses
Design
In this study, 30 nurses will be selected using a pre-test and post-test research design with one intervention group and one control group. The sampling method will be non-random. The research will be conducted in one phase with two groups of 15 participants each.
Settings and conduct
Nurses will be selected from a hospital in Mashhad, and the sessions will take place at the university clinic. The psychotherapy sessions will be conducted individually, consisting of 8 sessions, each lasting 45 minutes. The protocol used will be the self-compassion mindfulness protocol developed by Neff and colleagues.
Participants/Inclusion and exclusion criteria
The criteria for entering this study are being a nurse, experiencing burnout, and having psychological distress. The exclusion criteria are nurses who have recently entered the profession.
Intervention groups
This study involves two groups: an intervention group and a control group (15 participants in each group). At the beginning of the study, both groups will complete the Maslach Burnout Inventory and the Kessler Psychological Distress Scale. The intervention group will then undergo 8 sessions of psychotherapy based on the self-compassion protocol (Neff and Germer). After the intervention, both groups will retake the initial assessments, and the results will be compared.
Main outcome variables
Compassion, job burnout, psychological disturbance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240607062031N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: registered_while_recruiting

Last update: 2024-09-01, 1403/06/11
Update count: 1
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Minoo Shafiniya
Name of organization / entity
Hakim Toos University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 1163
Email address
msihnaofoi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a mindfulness-based compassion care program on burnout and psychological distress.
Public title
The effectiveness of a mindfulness-based compassion care program on burnout and psychological distress.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses Having job burnout Having psychological disturbance
Exclusion criteria:
Newly hired nurses (because they don't have job burnout)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Daneshfah street, between Daneshgah 16 & 18
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-08-03, 1403/05/13
Ethics committee reference number
IR.MUMS.REC.1403.185

Health conditions studied

1

Description of health condition studied
Job burnout and psychological disturbance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Job burnout and psychological disturbance
Timepoint
The beginning and end of the study
Method of measurement
Maslach burnout questionnaire and Kessler psychological distress questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will undergo 8 sessions of mindful self-compassion therapy. At both the beginning and the end of the study, they will complete assessments for burnout and psychological distress.
Category
Rehabilitation

2

Description
Control group: The control group will not receive any intervention and will only complete the burnout and psychological distress assessments at the start and end of the study.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Minoo Shafi'niya
Street address
No. 52, Rahnamaei 14, Rahnamaei blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185654355
Phone
+98 990 019 9778
Email
msihnaofoi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Personal
Full name of responsible person
Minoo Shafi'niya
Street address
No. 52, Rahnamaei 14, Rahnamaei blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185654355
Phone
+98 990 019 9778
Email
msihnaofoi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
All costs are borne by the student.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Minoo Shafi'niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 52, Rahnamaei 14, Rahnamaei blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185654355
Phone
+98 51 3847 1163
Email
msihnaofoi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Minoo Shafi'niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.52, Rahnamaei 14, Rahnamaei blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185654355
Phone
+98 51 3847 1163
Email
msihnaofoi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Minoo Shafi'niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 52, Rahnamaei 14, Rahnamaei blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185654355
Phone
+98 51 3847 1163
Email
msihnaofoi@gmail.com

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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The clinical protocol and report will be shared after the completion of the thesis.
When the data will become available and for how long
One month after registering the thesis
To whom data/document is available
researchers
Under which criteria data/document could be used
In order to conduct further research related to the intervention carried out.
From where data/document is obtainable
msihnaofoi@gmail.com
What processes are involved for a request to access data/document
An email must first be sent to the provided address containing the requester's information and the reasons for their need for documentation. The email will then be reviewed, and if the information is accurate and the reasons are sufficient, the requested documentation will be sent to the same email.
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