BurnoutNCT03657563
Improving Health of Nurses With Burnout Through Positive Psychological Intervention
A study testing Positive psychological intervention in people with Burnout, run by Central South University at 1 site in China.
Trial summary
Burnout is usually regarded as a response to chronic professional stressors like high workload, unfavorable emotion and complex interpersonal relationships. A high prevalence of burnout was found in many countries, and large-scale studies also showed high levels of burnout in Chinese nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- Positive psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- officially employed licensed nurses; burnout score higher than 1.49; had a telephone on which WeChat could be installed.
Who cannot join
- pregnant; current endocrine disorder; taking hormone drugs such as contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Positive Psychological Intervention on Improving Health of Nurses With Burnout
Burnout is usually regarded as a response to chronic professional stressors like high workload, unfavorable emotion and complex interpersonal relationships. A high prevalence of burnout was found in many countries, and large-scale studies also showed high levels of burnout in Chinese nurses. As a stress-related syndrome, burnout was found to have detrimental influences on both psychological and physical health of nurses. Psychological problems such as depression and insomnia are verified to be associated with burnout. Endocrine dysfunction such as abnormal cortisol secretion rhythm occurred in shift-work nurses. Thyroid dysfunction was increasing and a sample of nurses were diagnosed with thyroid nodules and thyroid hormonal disorder during annual physical examination. Therefore, it is important to take measures to alleviate nurses' burnout to improve health.
Positive psychological interventions are defined as treatment methods or intentional activities to enhance person's positive emotions, cognitions and behaviours. In these methods and activities, people are usually required to finish a systematic exercise. According to a recent meta-analysis, Positive psychological interventions showed effectiveness in enhancing participants' well-being and reducing depressive symptoms. Therefore, this study aims to explore whether positive psychological intervention could reduce burnout and improve health of nurses.
- Conditions
- Burnout
- Being tested
- Positive psychological intervention
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive psychological interventionOther
Participants in the intervention group are required to record three good things every night before sleeping for five days a week using WeChat. Such things could be ordinary, minor or important.
WeChat is a common communication tool used in China, just like Facebook, basic messages could be sent individually and posting pictures or texts is also available.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Nurses with burnout are recruited in the intervention group and participate in positive psychological intervention. Receives: Other: Positive psychological intervention |
| Control group | No intervention | Nurses with burnout are recruited in the control group and none interventions are conducted to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Burnout at six months
Burnout of nurses is measured by Maslach Burnout Inventory-General Survey.
Measured: The measurement was taken at baseline and six months.
Change from Baseline Morning Plasma Cortisol at six months
The level of cortisol is assayed by using chemiluminescence method.
Measured: The measurement was taken at baseline and six months.
Change from Baseline Thyroid Related Hormones at six months
Triiodothyronine (T3), thyroxine (T4) and thyroid stimulating hormone (TSH) are assayed by using chemiluminescence method.
Measured: The measurement was taken at baseline and six months.
Secondary outcomes (3)
Change from Baseline Resilience at six months
Resilience of nurses is measured by Connor-Davidson Resilience Scale.
Measured: The measurement was taken at baseline and six months.
Change from Baseline Coping at six months
The level of coping among nurses is measured by Trait Coping Style Questionnaire.
Measured: The measurement was taken at baseline and six months.
Change from Baseline Self-efficacy at six months
The level of self-efficacy among nurses is measured by General Self-Efficacy Scale.
Measured: The measurement was taken at baseline and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanhui Luo, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657563
- Sponsor's protocol ID
- 2015053
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Positive Psychological Intervention on Improving Health of Nurses With Burnout
- ClinicalTrials.gov ID
- NCT03657563
- Acronym / sponsor ID
- 2015053
- Conditions
- Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Sep 2018 (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 is usually regarded as a response to chronic professional stressors like high workload, unfavorable emotion and complex interpersonal relationships. A high prevalence of burnout was found in many countries, and large-scale studies also showed high levels of burnout in Chinese nurses. As a stress-related syndrome, burnout was found to have detrimental influences on both psychological and physical health of nurses. Psychological problems such as depression and insomnia are verified to be associated with burnout. Endocrine dysfunction such as abnormal cortisol secretion rhythm occurred in shift-work nurses. Thyroid dysfunction was increasing and a sample of nurses were diagnosed with thyroid nodules and thyroid hormonal disorder during annual physical examination. Therefore, it is important to take measures to alleviate nurses' burnout to improve health.
Positive psychological interventions are defined as treatment methods or intentional activities to enhance person's positive emotions, cognitions and behaviours. In these methods and activities, people are usually required to finish a systematic exercise. According to a recent meta-analysis, Positive psychological interventions showed effectiveness in enhancing participants' well-being and reducing depressive symptoms. Therefore, this study aims to explore whether positive psychological intervention could reduce burnout and improve health of nurses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Positive psychological interventionNurses with burnout are recruited in the intervention group and participate in positive psychological intervention. |
| Control group | No intervention | –Nurses with burnout are recruited in the control group and none interventions are conducted to them. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- officially employed licensed nurses; burnout score higher than 1.49; had a telephone on which WeChat could be installed.
Key exclusion criteria (1 listed)
- pregnant; current endocrine disorder; taking hormone drugs such as contraceptives.
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 |
|---|---|---|
| Positive psychological interventionParticipants in the intervention group are required to record three good things every night before sleeping for five days a week using WeChat. Such things could be ordinary, minor or important. WeChat is a common communication tool used in China, just like Facebook, basic messages could be sent individually and posting pictures or texts is also available. | Other | Intervention group |
Primary outcome
Change from Baseline Burnout at six months
Time frame: The measurement was taken at baseline and six months.
Burnout of nurses is measured by Maslach Burnout Inventory-General Survey.
Change from Baseline Morning Plasma Cortisol at six months
Time frame: The measurement was taken at baseline and six months.
The level of cortisol is assayed by using chemiluminescence method.
Change from Baseline Thyroid Related Hormones at six months
Time frame: The measurement was taken at baseline and six months.
Triiodothyronine (T3), thyroxine (T4) and thyroid stimulating hormone (TSH) are assayed by using chemiluminescence method.
3 secondary outcomes
Change from Baseline Resilience at six months
Time frame: The measurement was taken at baseline and six months.
Change from Baseline Coping at six months
Time frame: The measurement was taken at baseline and six months.
Change from Baseline Self-efficacy at six months
Time frame: The measurement was taken at baseline and six 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 5 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive psychological intervention in people with Burnout, run by Central South 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 5 Sep 2018. 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?
Change from Baseline Burnout at six months (time frame: The measurement was taken at baseline and six months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.