Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses
Primary Purpose
Burnout, Psychological
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
psychological intervention based on psychological capital
Sponsored by
About this trial
This is an interventional other trial for Burnout focused on measuring Burnout, oncology nurses, positive psychology capital intervention, immune variables
Eligibility Criteria
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.
Sites / Locations
- Affiliated Tumor of Guangxi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PCI group
Control group
Arm Description
intervention based on psychological capital model
routine psychological counseling
Outcomes
Primary Outcome Measures
scores on Maslach Burnout Inventory-General Survey (MBI-GS)
change of the MBI scores, which ranges from 0 to 6, with higher scores indicating more severe burnout.
Secondary Outcome Measures
scores on Positive psychological capital Questionnaire (PPQ),
change of the PPQ scores, , which ranges from 1 to 6, with higher scores indicating higher level of psychological capital.
Full Information
NCT ID
NCT05510414
First Posted
August 17, 2022
Last Updated
August 18, 2022
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05510414
Brief Title
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses
Official Title
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Psychological
Keywords
Burnout, oncology nurses, positive psychology capital intervention, immune variables
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention program was taught by experts with at least the title of deputy chief nurse who had been engaged in clinical psychological nursing for a long time. These teachers helped nurses with burnout to develop their own positive psychology, learn optimism, embrace hope, find available support systems and resources, plan their careers. Training took the form mainly of Balint groups, lectures, group discussions, video watching and outdoor development. Personalized counseling was provided to address specific psychological problems in individuals, in a way that ensured personal privacy. The intervention occurred as 12 sessions of 60 min each, twice a month, lasting altogether six months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCI group
Arm Type
Experimental
Arm Description
intervention based on psychological capital model
Arm Title
Control group
Arm Type
No Intervention
Arm Description
routine psychological counseling
Intervention Type
Behavioral
Intervention Name(s)
psychological intervention based on psychological capital
Intervention Description
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 .
Primary Outcome Measure Information:
Title
scores on Maslach Burnout Inventory-General Survey (MBI-GS)
Description
change of the MBI scores, which ranges from 0 to 6, with higher scores indicating more severe burnout.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
scores on Positive psychological capital Questionnaire (PPQ),
Description
change of the PPQ scores, , which ranges from 1 to 6, with higher scores indicating higher level of psychological capital.
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xue-Mei You, MD
Organizational Affiliation
Guangxi Medical University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor of Guangxi University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
5350021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32824724
Citation
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.
Results Reference
background
PubMed Identifier
34609405
Citation
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.
Results Reference
background
PubMed Identifier
31753226
Citation
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.
Results Reference
background
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Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses
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