BurnoutNCT05510414
Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses
A study testing psychological intervention based on psychological capital in people with Burnout and Psychological, run by Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Psychological
- What is being tested?
- psychological intervention based on psychological capital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were officially employed and licensed nurses who had been working in the cancer hospital for at least 2 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout, Psychological
- Being tested
- psychological intervention based on psychological capital
- Keywords
- Burnout, oncology nurses, positive psychology capital intervention, immune variables
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological intervention based on psychological capitalBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| PCI group | Experimental | intervention based on psychological capital model Receives: Behavioral: psychological intervention based on psychological capital |
| Control group | No intervention | routine psychological counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Secondary outcomes (1)
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.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2018
- Primary completion30 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Xue-Mei You, MD, Principal investigator, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510414
- Sponsor's protocol ID
- PCI burnout
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32824724Ciobanu 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.
PubMed 34609405Luo 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.
PubMed 31753226
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05510414
- Acronym / sponsor ID
- PCI burnout
- Conditions
- Burnout, Psychological
- Keywords
- Burnout, oncology nurses, positive psychology capital intervention, immune variables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PCI group | Experimental | Behavioral: psychological intervention based on psychological capitalintervention based on psychological capital model |
| Control group | No intervention | –routine psychological counseling |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects were officially employed and licensed nurses who had been working in the cancer hospital for at least 2 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological intervention based on psychological capitalPsychological 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 . | Behavioural | PCI group |
Primary outcome
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.
1 secondary outcome
scores on Positive psychological capital Questionnaire (PPQ),
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 32824724An 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.
- Background: PubMed 34609405Ciobanu 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.
- Background: PubMed 31753226Luo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue-Mei You, MD principal investigator
Guangxi Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological intervention based on psychological capital in people with Burnout and Psychological, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores on Maslach Burnout Inventory-General Survey (MBI-GS) (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510414, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.