BurnoutNCT05716828
Effect of Balint Group on Burnout and Self-efficacy of Nurse Leaders in China: A Randomised Controlled Trial
A study testing Balint group activities in people with Burnout and Self Efficacy, run by Peking University People's Hospital at 1 site in China.
Trial summary
Background: Burnout is common among nurses and is related to negative outcomes of medical care. This study aimed to explore the effectiveness of Balint group activities in burnout reduction among nurse leaders in a Chinese hospital. Methods: This was a randomised controlled trial with a pre- and post-test. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Self Efficacy
- What is being tested?
- Balint group activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jan 2022
- 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
- nurse leaders in clinical departments
- voluntary participation
Who cannot join
- previous participation in Balint groups
Trial locations and contacts
1 site in 1 country.
About this study
Background: Burnout is common among nurses and is related to negative outcomes of medical care. This study aimed to explore the effectiveness of Balint group activities in burnout reduction among nurse leaders in a Chinese hospital.
Methods: This was a randomised controlled trial with a pre- and post-test. A total of 80 nurse leaders were randomly assigned to either a Balint group (n=40) or a non-Balint group (n=40). Participants in the Balint group completed Balint training for a period of three months. Participants in both groups completed the Maslach Burnout Inventory-Human Services Survey (MBI) and the General Self-Efficacy Scale (GSES) at the beginning and end of the study（three months later ）. Balint group members also completed the Group Climate Questionnaire-Short Format the end of the study（three months later ）.
- Conditions
- Burnout, Self Efficacy
- Being tested
- Balint group activities
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balint group activitiesOther
A Balint group is a working form that focuses on the professional doctor-patient relationship. Participants in the Balint group completed Balint training for a period of at least three months, which included two lectures and 10 small group discussion sessions held once a month for one hour at a time (on Thursdays from 12 to 1 PM). Balint group is a closed group including one to two group leaders and six to twelve participants, with sessions lasting 60 to 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Balint group | Experimental | Participants in the Balint group completed Balint training for a period of three months. Receives: Other: Balint group activities |
| non-Balint group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale emotional exhaustion (MBI-EE)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The EE subscale evaluates the feeling of excessive emotional stress and exhaustion due to work, which is characterized by mental, emotional, and physical exhaustion
Measured: The first time for participants in both groups was assessed the MBI-EE questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale emotional exhaustion (MBI-EE)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The EE subscale evaluates the feeling of excessive emotional stress and exhaustion due to work, which is characterized by mental, emotional, and physical exhaustion
Measured: The second time for participants in both groups was assessed the MBI-EE questionnaire through Balint group activities completion, 3 months later
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale depersonalization (MBI-DP)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The DP subscale measures unsympathetic and impersonal response to patients, and is regarded as a form of alienation.
Measured: The first time for participants in both groups was assessed the MBI-DP questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale depersonalization (MBI-DP)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The DP subscale measures unsympathetic and impersonal response to patients, and is regarded as a form of alienation.
Measured: The second time for participants in both groups was assessed the MBI-DP questionnaire through Balint group activities completion, 3 months later
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale personal accomplishment (MBI- PA)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The PA subscale assesses work-related ability and sense of accomplishment .
Measured: The first time for participants in both groups was assessed the MBI-PA questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale personal accomplishment (MBI- PA)
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The PA subscale assesses work-related ability and sense of accomplishment .
Measured: The second time for participants in both groups was assessed the MBI-PA questionnaire through Balint group activities completion, 3 months later
Secondary outcomes (2)
The General Self-Efficacy Scale (GSES)
The General Self-Efficacy Scale (GSES) is a 10-item scale used to measure individuals' overall self-confidence in dealing with different environmental challenges or unprecedented situations. Participants are asked to rate 10 questions by choosing one of four response options: 1 (completely incorrect), 2 (almost incorrect), 3 (relatively correct), or 4 (completely correct). A higher score indicates a higher level of general self-efficacy.
Measured: The first time for participants in both groups was assessed the GSES questionnaire at baseline.
The General Self-Efficacy Scale (GSES)
The General Self-Efficacy Scale (GSES) is a 10-item scale used to measure individuals' overall self-confidence in dealing with different environmental challenges or unprecedented situations. Participants are asked to rate 10 questions by choosing one of four response options: 1 (completely incorrect), 2 (almost incorrect), 3 (relatively correct), or 4 (completely correct). A higher score indicates a higher level of general self-efficacy.
Measured: The second time for participants in both groups was assessed the GSES questionnaire through Balint group activities completion, 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jul 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qu Shan, Peking University People's Hospital
- Investigators
- Shan Qu, Qu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716828
- Sponsor's protocol ID
- balint2022
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minjie Z, Zhijuan X, Xinxin S, Xinzhu B, Shan Q. The effects of cognitive behavioral therapy on health-related quality of life, anxiety, depression, illness perception, and in atrial fibrillation patients: a six-month longitudinal study. BMC Psychol. 2023 Dec 7;11(1):431. doi: 10.1186/s40359-023-01457-z.
PubMed 38062475
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balint Group on Burnout and Self-efficacy of Nurse Leaders in China: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05716828
- Acronym / sponsor ID
- balint2022
- Conditions
- Burnout, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Feb 2023 (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.
Background: Burnout is common among nurses and is related to negative outcomes of medical care. This study aimed to explore the effectiveness of Balint group activities in burnout reduction among nurse leaders in a Chinese hospital.
Methods: This was a randomised controlled trial with a pre- and post-test. A total of 80 nurse leaders were randomly assigned to either a Balint group (n=40) or a non-Balint group (n=40). Participants in the Balint group completed Balint training for a period of three months. Participants in both groups completed the Maslach Burnout Inventory-Human Services Survey (MBI) and the General Self-Efficacy Scale (GSES) at the beginning and end of the study（three months later ）. Balint group members also completed the Group Climate Questionnaire-Short Format the end of the study（three months later ）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balint group | Experimental | Other: Balint group activitiesParticipants in the Balint group completed Balint training for a period of three months. |
| non-Balint group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- nurse leaders in clinical departments
- voluntary participation
Key exclusion criteria (1 listed)
- previous participation in Balint groups
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 |
|---|---|---|
| Balint group activitiesA Balint group is a working form that focuses on the professional doctor-patient relationship. Participants in the Balint group completed Balint training for a period of at least three months, which included two lectures and 10 small group discussion sessions held once a month for one hour at a time (on Thursdays from 12 to 1 PM). Balint group is a closed group including one to two group leaders and six to twelve participants, with sessions lasting 60 to 90 minutes. | Other | Balint group |
Primary outcome
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale emotional exhaustion (MBI-EE)
Time frame: The first time for participants in both groups was assessed the MBI-EE questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The EE subscale evaluates the feeling of excessive emotional stress and exhaustion due to work, which is characterized by mental, emotional, and physical exhaustion
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale emotional exhaustion (MBI-EE)
Time frame: The second time for participants in both groups was assessed the MBI-EE questionnaire through Balint group activities completion, 3 months later
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The EE subscale evaluates the feeling of excessive emotional stress and exhaustion due to work, which is characterized by mental, emotional, and physical exhaustion
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale depersonalization (MBI-DP)
Time frame: The first time for participants in both groups was assessed the MBI-DP questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The DP subscale measures unsympathetic and impersonal response to patients, and is regarded as a form of alienation.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale depersonalization (MBI-DP)
Time frame: The second time for participants in both groups was assessed the MBI-DP questionnaire through Balint group activities completion, 3 months later
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The DP subscale measures unsympathetic and impersonal response to patients, and is regarded as a form of alienation.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale personal accomplishment (MBI- PA)
Time frame: The first time for participants in both groups was assessed the MBI-PA questionnaire at baseline.
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The PA subscale assesses work-related ability and sense of accomplishment .
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale personal accomplishment (MBI- PA)
Time frame: The second time for participants in both groups was assessed the MBI-PA questionnaire through Balint group activities completion, 3 months later
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) includes 22 items across three domains: emotional exhaustion (EE; 9 items), depersonalization (DP; 5 items), and personal accomplishment (PA; 8 items). The scoring range for each item is 0 (never felt) to 6 (felt every day). The PA subscale assesses work-related ability and sense of accomplishment .
2 secondary outcomes
The General Self-Efficacy Scale (GSES)
Time frame: The first time for participants in both groups was assessed the GSES questionnaire at baseline.
The General Self-Efficacy Scale (GSES)
Time frame: The second time for participants in both groups was assessed the GSES questionnaire through Balint group activities completion, 3 months later
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 8 Feb 2023.
- Derived from this study: PubMed 38062475Minjie Z, Zhijuan X, Xinxin S, Xinzhu B, Shan Q. The effects of cognitive behavioral therapy on health-related quality of life, anxiety, depression, illness perception, and in atrial fibrillation patients: a six-month longitudinal study. BMC Psychol. 2023 Dec 7;11(1):431. doi: 10.1186/s40359-023-01457-z.
- 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.
Shan Qu, Qu principal investigator
Peking University People's 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 Balint group activities in people with Burnout and Self Efficacy, run by Peking University People's Hospital 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 2 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 8 Feb 2023. 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?
Maslach Burnout Inventory-Human Services Survey (MBI-HSS) subscale emotional exhaustion (MBI-EE) (time frame: The first time for participants in both groups was assessed the MBI-EE questionnaire at baseline.). The study lists 6 primary outcomes in all. 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 NCT05716828, which also lists 1 linked publication.
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 8 Feb 2023.