MenopauseNCT04728126
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
An observational study of Menopause and Burnout Syndrome, run by Nazarbayev University Medical Center.
Trial summary
This study aims at evaluating the burnout in women healthcare providers (physicians and nurses) Kazakhstan settings, and to investigate the potential parameters that play a role in increasing the risk of burnout. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women only
- Conditions the study is for
- Menopause, Burnout Syndrome
- What is being tested?
- Survey
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Aug 2024
- Phase
- Observational
- 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 45 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Since this study is aimed to investigate and determine the quality of life in menopausal women, the participants are menopausal women aged 45 years and older.
Who may be able to join
- menopause
Who cannot join
- severe chronic diseases, including psychological/psychiatric comorbidities and use of specific drugs for them
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in University Hospitals of UMC in Nur-Sultan
This study aims at evaluating the burnout in women healthcare providers (physicians and nurses) Kazakhstan settings, and to investigate the potential parameters that play a role in increasing the risk of burnout. This study would apply the Oldenburg Burnout Inventory (OBI) in a sample of menopausal healthcare providers belonging to the University Medical Center (UMC) - quaternary healthcare institution in Nur-Sultan, Kazakhstan.
Read the detailed description
Menopause is a complex physiological process that marks the end of the reproductive phase of a woman's life, and some women in that population refer to various symptoms like hot flashes, sleep disturbances, decreased physical strength, mood changes, and bladder irritability. The increasing presence of women in the workplace and the aging of the women's workforce have elicited growing interest in the link between menopause and work. Studies in the occupational-medicine field provide evidence of how certain aspects of the physical work environment exacerbate menopausal symptoms. Furthermore, there are direct and indirect costs from a lack of organizational support for menopausal women in terms of increased absenteeism, presenteeism, and medical checkups.
Occupational Burnout (OB) is a syndrome of physical and psychological exhaustion of health care professionals. It has three dimensions relating to emotional exhaustion, depersonalization and lack of personal achievements. Extant studies in the occupational health psychology (OHP) field have highlighted many factors in the health-care providers work environment that might increase the risk of developing burnout. It has been well-established that among human-service professionals, the most important burnout risk is represented by the emotionally demanding relationships between caregivers and recipients.
Excessive workload and loss of control in one's profession are cited as the top reasons for burnout among physicians. Likewise, among surgeons, a primary contributing factor for burnout is long working hours, with only a third of surgeons feeling their work schedule had left enough time for personal or family life. Work family conflicts are also more common if surgeons are married to another physician or surgeon. Clearly these reasons imply that a primary root of the problem lies with organizations and care delivery systems rather than the individuals. Furthermore, workplace politics can be associated with a higher risk of burnout, depression and coronary artery disease. Adequate staffing, good leadership and support were found to reduce the risk of burnout, highlighting the importance of fair hospital management, policy and practice. Nevertheless, causes of burnout are not always organizational in nature; a proportion are due to the mishandling of stress related to the profession or at work. This is especially evident among vulnerable physicians with traits including idealism, perfectionism and a great sense of responsibility. Early career physicians (i.e. ≤ 5 years in practice) who have these personality traits are at a greater risk, particularly during the first few years immediately after completion of their fellowship. An early presence in academic and private settings and being involved in interventional procedures can be stressful to an early career physician. In addition, certain patient factors may also contribute to burnout; these include unrealistic expectations, declining patient health and aggression from patients. Prolonged patient contact and development of family-like relationships may also result in emotional detachment and burnout.
In summary, contributing factors leading to burnout are poor working conditions with long work shifts, stressful on-call duties, lack of appreciation, and poor social interactions. Burnout can lead to adverse consequences, such as depression, substance use, and suicidal ideation. This can result in poor patient care, increasing total length of stay, re-admissions, and major medical errors. Due to increased scrutiny of patient and healthcare costs, along with increased lawsuits as a result of major medical errors, it is crucial for both the hospital management and healthcare providers to recognize and address burnout. Comprehensive professional training such as Cognitive behavioral therapy (CBT), stress-reducing activities such as mindfulness and group activities, and strict implementation of work-hour limitations are a few methods that may help to manage burnout and increase productivity in hospitals.This study aims at evaluating the burnout in women healthcare providers (physicians and nurses) Kazakhstan settings, and to investigate the potential parameters that play a role in increasing the risk of burnout. This study would apply the OBI in a sample of menopausal healthcare providers belonging to the UMC - quaternary healthcare institution in Nur-Sultan, Kazakhstan.
- Conditions
- Menopause, Burnout Syndrome
- Being tested
- Survey
- Keywords
- Menopause, Quality of life, Quality of work life, Burnout, Emotional exhaustion
- Medical subject headings
- Burnout, Psychological, Emotional Exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The questionnaire will include socio-demographic information (i.e., gender, age, job seniority) and sub-scales for measuring study variables (i.e., menopausal symptoms, social and personal resources, burnout, and work ability).
Menopausal symptoms will be assessed using the Menopause-Specific Quality of Life questionnaire.
Job burnout will be measured through OBI inventory, which consists of 16 items describing the states of emotional exhaustion and detachment - two core dimension of burnout, and were developed to meet different occupational groups.
The menopause and the quality of working environment will be assessed using the Questionnaire developed by National Health Service in England and Wales.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Female health-care givers aged 45 to 64 years. The study participants will be recruited from UMC (Clinical Academic Department (CAD) of Women's Health, Pediatric Clinical Academic Department, Republic Diagnostic Center (RDC) and National Center for Children's Rehabilitation (NCCR)), Nur-Sultan, Kazakhstan. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Quality of Life Measurement
Participants will be asked to fill a self-administered Menopause-Specific Quality of Life questionnaire, which comprises 29 items.
This Menopause-Specific Quality of Life contains items that assess 4 main types of menopausal symptoms: vasomotor, psychosocial, physical, sexual. Each item is rated as present or not present; if present, how bothersome the items are on a scale of 0 (not bothersome) to 6 (extremely bothersome).
Measured: 36 month
Job burnout
Job burnout will be measured using Oldenburg Burnout Inventory.
Oldenburg Burnout Inventory consists of 16 items on the states of emotional exhaustion and detachment, and were developed to meet different occupational groups. The degree of agreement with 16 items of Oldenburg Burnout Inventory uses scale from 1 to 4, where 1- strongly agree and 4 - strongly disagree.
Measured: 36 month
The menopause and quality of working environment
The menopause and quality of working environment will be assessed using a questionnaire developed by National Health Service in England and Wales.
This questionnaire will enable information about the menopause experience, how menopause affects the workplace and vice versa. Moreover, it will provide information about the performance management during menopause and enable foundations about the eventual need for possible ways of raising awareness at work.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startSep 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Sanja Terzic, Nazarbayev University Medical Center
- Investigators
- Milan Terzic, Study director, Nazarbayev University Medical CenterGauri Bapayeva, Study director, Nazarbayev University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728126
- Sponsor's protocol ID
- 023-2020
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in University Hospitals of UMC in Nur-Sultan
- ClinicalTrials.gov ID
- NCT04728126
- Acronym / sponsor ID
- 023-2020
- Conditions
- Menopause, Burnout Syndrome
- Keywords
- Menopause, Quality of life, Quality of work life, Burnout, Emotional exhaustion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Nazarbayev University Medical CenterUniversity, hospital or other
- Collaborators
- University of South Florida, Università degli Studi dell'Insubria
- Study start
- Sep 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 28 Jan 2021 (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.
This study aims at evaluating the burnout in women healthcare providers (physicians and nurses) Kazakhstan settings, and to investigate the potential parameters that play a role in increasing the risk of burnout. This study would apply the Oldenburg Burnout Inventory (OBI) in a sample of menopausal healthcare providers belonging to the University Medical Center (UMC) - quaternary healthcare institution in Nur-Sultan, Kazakhstan.
Detailed description
Menopause is a complex physiological process that marks the end of the reproductive phase of a woman's life, and some women in that population refer to various symptoms like hot flashes, sleep disturbances, decreased physical strength, mood changes, and bladder irritability. The increasing presence of women in the workplace and the aging of the women's workforce have elicited growing interest in the link between menopause and work. Studies in the occupational-medicine field provide evidence of how certain aspects of the physical work environment exacerbate menopausal symptoms. Furthermore, there are direct and indirect costs from a lack of organizational support for menopausal women in terms of increased absenteeism, presenteeism, and medical checkups.
Occupational Burnout (OB) is a syndrome of physical and psychological exhaustion of health care professionals. It has three dimensions relating to emotional exhaustion, depersonalization and lack of personal achievements. Extant studies in the occupational health psychology (OHP) field have highlighted many factors in the health-care providers work environment that might increase the risk of developing burnout. It has been well-established that among human-service professionals, the most important burnout risk is represented by the emotionally demanding relationships between caregivers and recipients.
Excessive workload and loss of control in one's profession are cited as the top reasons for burnout among physicians. Likewise, among surgeons, a primary contributing factor for burnout is long working hours, with only a third of surgeons feeling their work schedule had left enough time for personal or family life. Work family conflicts are also more common if surgeons are married to another physician or surgeon. Clearly these reasons imply that a primary root of the problem lies with organizations and care delivery systems rather than the individuals. Furthermore, workplace politics can be associated with a higher risk of burnout, depression and coronary artery disease. Adequate staffing, good leadership and support were found to reduce the risk of burnout, highlighting the importance of fair hospital management, policy and practice. Nevertheless, causes of burnout are not always organizational in nature; a proportion are due to the mishandling of stress related to the profession or at work. This is especially evident among vulnerable physicians with traits including idealism, perfectionism and a great sense of responsibility. Early career physicians (i.e. ≤ 5 years in practice) who have these personality traits are at a greater risk, particularly during the first few years immediately after completion of their fellowship. An early presence in academic and private settings and being involved in interventional procedures can be stressful to an early career physician. In addition, certain patient factors may also contribute to burnout; these include unrealistic expectations, declining patient health and aggression from patients. Prolonged patient contact and development of family-like relationships may also result in emotional detachment and burnout.
In summary, contributing factors leading to burnout are poor working conditions with long work shifts, stressful on-call duties, lack of appreciation, and poor social interactions. Burnout can lead to adverse consequences, such as depression, substance use, and suicidal ideation. This can result in poor patient care, increasing total length of stay, re-admissions, and major medical errors. Due to increased scrutiny of patient and healthcare costs, along with increased lawsuits as a result of major medical errors, it is crucial for both the hospital management and healthcare providers to recognize and address burnout. Comprehensive professional training such as Cognitive behavioral therapy (CBT), stress-reducing activities such as mindfulness and group activities, and strict implementation of work-hour limitations are a few methods that may help to manage burnout and increase productivity in hospitals.This study aims at evaluating the burnout in women healthcare providers (physicians and nurses) Kazakhstan settings, and to investigate the potential parameters that play a role in increasing the risk of burnout. This study would apply the OBI in a sample of menopausal healthcare providers belonging to the UMC - quaternary healthcare institution in Nur-Sultan, Kazakhstan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: SurveyFemale health-care givers aged 45 to 64 years. The study participants will be recruited from UMC (Clinical Academic Department (CAD) of Women's Health, Pediatric Clinical Academic Department, Republic Diagnostic Center (RDC) and National Center for Children's Rehabilitation (NCCR)), Nur-Sultan, Kazakhstan. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Since this study is aimed to investigate and determine the quality of life in menopausal women, the participants are menopausal women aged 45 years and older.
Key inclusion criteria (1 listed)
- menopause
Key exclusion criteria (1 listed)
- severe chronic diseases, including psychological/psychiatric comorbidities and use of specific drugs for them
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 |
|---|---|---|
| SurveyThe questionnaire will include socio-demographic information (i.e., gender, age, job seniority) and sub-scales for measuring study variables (i.e., menopausal symptoms, social and personal resources, burnout, and work ability). Menopausal symptoms will be assessed using the Menopause-Specific Quality of Life questionnaire. Job burnout will be measured through OBI inventory, which consists of 16 items describing the states of emotional exhaustion and detachment - two core dimension of burnout, and were developed to meet different occupational groups. The menopause and the quality of working environment will be assessed using the Questionnaire developed by National Health Service in England and Wales. | Other | Study group |
Primary outcome
Menopause Quality of Life Measurement
Time frame: 36 month
Participants will be asked to fill a self-administered Menopause-Specific Quality of Life questionnaire, which comprises 29 items. This Menopause-Specific Quality of Life contains items that assess 4 main types of menopausal symptoms: vasomotor, psychosocial, physical, sexual. Each item is rated as present or not present; if present, how bothersome the items are on a scale of 0 (not bothersome) to 6 (extremely bothersome).
Job burnout
Time frame: 36 month
Job burnout will be measured using Oldenburg Burnout Inventory. Oldenburg Burnout Inventory consists of 16 items on the states of emotional exhaustion and detachment, and were developed to meet different occupational groups. The degree of agreement with 16 items of Oldenburg Burnout Inventory uses scale from 1 to 4, where 1- strongly agree and 4 - strongly disagree.
The menopause and quality of working environment
Time frame: 36 month
The menopause and quality of working environment will be assessed using a questionnaire developed by National Health Service in England and Wales. This questionnaire will enable information about the menopause experience, how menopause affects the workplace and vice versa. Moreover, it will provide information about the performance management during menopause and enable foundations about the eventual need for possible ways of raising awareness at work.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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.
Milan Terzic study director
Nazarbayev University Medical Center
Gauri Bapayeva study director
Nazarbayev University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Burnout Syndrome, run by Nazarbayev University Medical Center.
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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanja Terzic (+77083240921, sanja.terzic@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Quality of Life Measurement (time frame: 36 month). 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 29 Jan 2021.