Protocol summary
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Study aim
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Examining the Effect of Mindful Self-Compassion Therapy on Reducing Psychological Distress and Burnout in Nurses
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Compassion, job burnout, psychological disturbance
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2024-08-10, 1403/05/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-08-05, 1403/05/15
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Expected recruitment end date
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2024-08-20, 1403/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of a mindfulness-based compassion care program on burnout and psychological distress.
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Public title
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The effectiveness of a mindfulness-based compassion care program on burnout and psychological distress.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Nurses
Having job burnout
Having psychological disturbance
Exclusion criteria:
Newly hired nurses (because they don't have job burnout)
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-08-03, 1403/05/13
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Ethics committee reference number
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IR.MUMS.REC.1403.185
Health conditions studied
1
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Description of health condition studied
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Job burnout and psychological disturbance
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Job burnout and psychological disturbance
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Timepoint
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The beginning and end of the study
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Method of measurement
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Maslach burnout questionnaire and Kessler psychological distress questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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All costs are borne by the student.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The clinical protocol and report will be shared after the completion of the thesis.
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When the data will become available and for how long
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One month after registering the thesis
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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In order to conduct further research related to the intervention carried out.
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From where data/document is obtainable
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msihnaofoi@gmail.com
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What processes are involved for a request to access data/document
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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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Comments
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