- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05510414
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses: a Randomized Controlled Trial
Burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. How to mitigate and prevent burnout and improve nursing performance outcomes is an urgent problem for nursing manager.
In a sample of 99 oncology nurses, immunological characteristics were compared to burnout scores. In a randomized trial, 90 oncology nurses suffering burnout were randomized to receive psychological capital intervention or routine psychological care. Participants were assessed before and after treatment using measures of burnout, psychological capital and immunological characteristics.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. And burnout-associated biomarkers remain controversial, and their potential roles in burnout are still unclear.
This study was a randomized controlled trial in which the independent variable was group psychological intervention, while the dependent variables were pre- and post-intervention scores on the Maslach burnout inventory and on the psychological capital scale, as well as values for various immunological indicators. In Stage 1 of the study, recruited subjects completed the psychological capital questionnaire and blood was sampled. In Stage 2, the research team administered a custom-designed psychological capital intervention (PCI) to part of the sample, while the other part received routine care . The PCI group received 1 h of counseling twice weekly for a total of 24 weeks in total. In Stage 3, the PCI and control groups completed the questionnaires again and provided blood samples.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangxi
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Nanning, Guangxi, China, 5350021
- Affiliated Tumor of Guangxi University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects were officially employed and licensed nurses who had been working in the cancer hospital for at least 2 years.
Exclusion Criteria:
- Subjects had recently suffered personal health problems or significant negative life events, such as the death or serious illness of a family member, or if they were on maternity leave or other types of leave from their nursing job.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PCI group
intervention based on psychological capital model
|
Psychological capital would be modified via various training programs in order to manage burnout among nurses.
When the four core psychological resources are combined, they may form a higher-order construct that predicts attitudes and performance more strongly than any of the four components by themselves .
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NO_INTERVENTION: Control group
routine psychological counseling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
scores on Maslach Burnout Inventory-General Survey (MBI-GS)
Time Frame: baseline and 6 months
|
change of the MBI scores, which ranges from 0 to 6, with higher scores indicating more severe burnout.
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baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
scores on Positive psychological capital Questionnaire (PPQ),
Time Frame: baseline and 6 months
|
change of the PPQ scores, , which ranges from 1 to 6, with higher scores indicating higher level of psychological capital.
|
baseline and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xue-Mei You, MD, Guangxi Medical University Cancer Hospital
Publications and helpful links
General Publications
- An M, Shin ES, Choi MY, Lee Y, Hwang YY, Kim M. Positive Psychological Capital Mediates the Association between Burnout and Nursing Performance Outcomes among Hospital Nurses. Int J Environ Res Public Health. 2020 Aug 18;17(16):5988. doi: 10.3390/ijerph17165988.
- Ciobanu AM, Damian AC, Neagu C. Association between burnout and immunological and endocrine alterations. Rom J Morphol Embryol. 2021 Jan-Mar;62(1):13-18. doi: 10.47162/RJME.62.1.02.
- Luo YH, Li H, Plummer V, Cross WM, Lam L, Guo YF, Yin YZ, Zhang JP. An evaluation of a positive psychological intervention to reduce burnout among nurses. Arch Psychiatr Nurs. 2019 Dec;33(6):186-191. doi: 10.1016/j.apnu.2019.08.004. Epub 2019 Aug 19.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCI burnout
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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