MenopauseNCT04724135
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
An observational study of Menopause, run by Nazarbayev University Medical Center.
Trial summary
This study aims to investigate the quality of life of menopausal health-care providers in University Medical Center (UMC) hospitals in Nur-Sultan and identify whether there is a difference in the quality of life between two major groups of women health-care professionals: physicians and nurses, and to explore factors… Read more about this study
- Who is it for?
- Ages 45 to 64 years, women only
- Conditions the study is for
- Menopause
- 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
- We will include all menopausal health-care providers working in CAD of Women's Health and Pediatric CAD UMC, NCCR, and RDC, Nur-Sultan Kazakhstan. In order to get the highest possible response rate as well as evaluate the non-response bias, there is a need to follow-up to those who did not responded.
Who cannot join
- Women with serious health problems, such as severe chronic diseases, including psychological/psychiatric comorbidities, and use of specific drugs for them, will not be included in the study
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the quality of life of menopausal health-care providers in University Medical Center (UMC) hospitals in Nur-Sultan and identify whether there is a difference in the quality of life between two major groups of women health-care professionals: physicians and nurses, and to explore factors influencing on it.
Read the detailed description
Quality of life has turned into a reference for the so-called "state of wellbeing" that includes six domains: physical health, social relationships, psychological state, spiritual concerns, environmental features, and level of independence. Quality of life is perceived as a major health component, especially for menopausal women, and has become an essential research topic that has been discussed widely in the literature.
Therefore, from the HRQoL perspective, the consequences of the climacterium should be considered as a specific aspect of health-related quality of life in studies that include this segment of the population. The increased life expectancy of the general population and of women in particular, has turned women's health care in this phase of life into a priority; the way this should be accomplished, however, represents one of the main sources of public health debate.
Quality of work life is a comprehensive and general schema, which is essential in improving specialized personnel's satisfaction and attracting and preserving personnel. It also results in positive theories such as increasing profits and provocation. Nevertheless, although physicians and nurses are expected to provide patient care and improve their quality of life, their own needs and their own quality of life have been either largely underestimated or ignored.
Providing care in these cases is very demanding in physical, emotional, and spiritual terms. Their work requires certain qualities, such as empathy, compassion, and closeness to the individuals and families they care for. Therefore, daily work may be significantly influenced by the menopausal transition, especially in nurses and physicians Work is beneficial for menopausal women by providing fulfilment, self-esteem, identity and social needs. But working environments like those with lack of temperature control, cramped conditions, some uniforms and stress can also make menopause symptoms worse. Menopause refers to the time when a woman's menstrual period stops for 12 consecutive months after the last period and is characterized by a decline in the production of the ovarian hormones, mainly estrogen and progesterone. The lack of these hormones makes some women prone to experiencing common symptoms that include, but are not limited to, sleep disorders, mood alterations, hot flashes, depression, urinary tract infections, vaginal infections, and increased risk for osteoporosis and cardiovascular diseases. Providing up-to-date information to women about menopause, its management, and the use of menopausal hormone therapy (MHT) may serve as an important step towards treating postmenopausal symptoms thereby improving the QOL of postmenopausal women.
According to a recent study, the level of awareness and knowledge of women about the menopause is directly proportional to their ability to control their symptoms as menopausal symptoms can have a negative impact on work but menopause in the workplace still remains a taboo. This study aims to investigate the QoL of menopausal health-care providers in UMC hospitals in Nur-Sultan and identify whether there is a difference in the quality of life between two major groups of women health-care professionals: physicians and nurses, and to explore factors influencing on it.
- Conditions
- Menopause
- Being tested
- Survey
- Keywords
- Menopause, Quality of life, Healthcare providers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The first part will assess the sociodemographic variables and reproductive characteristics, and the second part contain the Menopause-Specific Quality of Life (MENQOL) questionnaire The 29 questions of the MENQOL are divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
| 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
The participants will be asked to indicate whether they had experienced symptoms or problems within the past month and, if so, to rate how bothersome they were on a seven-point Likert scale from 0 to 6: with 0 indicating that they were not at all bothered and 6 indicating that they were extremely bothered. The 29 questions of the MENQOL (supported by NCBI and NHI) are divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
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 posted26 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, Gauri Bapayeva, Nazarbayev University Medical Center
- Investigators
- Milan Terzic, MD, PhD, Study director, Nazarbayev University Medical CenterSanja Terzic, MD, Study director, Nazarbayev University Medical CenterGauri Bapayeva, MD, PhD, Principal investigator, Nazarbayev University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724135
- Sponsor's protocol ID
- 024-2020
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
- ClinicalTrials.gov ID
- NCT04724135
- Acronym / sponsor ID
- 024-2020
- Conditions
- Menopause
- Keywords
- Menopause, Quality of life, Healthcare providers
- 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
- 26 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 to investigate the quality of life of menopausal health-care providers in University Medical Center (UMC) hospitals in Nur-Sultan and identify whether there is a difference in the quality of life between two major groups of women health-care professionals: physicians and nurses, and to explore factors influencing on it.
Detailed description
Quality of life has turned into a reference for the so-called "state of wellbeing" that includes six domains: physical health, social relationships, psychological state, spiritual concerns, environmental features, and level of independence. Quality of life is perceived as a major health component, especially for menopausal women, and has become an essential research topic that has been discussed widely in the literature.
Therefore, from the HRQoL perspective, the consequences of the climacterium should be considered as a specific aspect of health-related quality of life in studies that include this segment of the population. The increased life expectancy of the general population and of women in particular, has turned women's health care in this phase of life into a priority; the way this should be accomplished, however, represents one of the main sources of public health debate.
Quality of work life is a comprehensive and general schema, which is essential in improving specialized personnel's satisfaction and attracting and preserving personnel. It also results in positive theories such as increasing profits and provocation. Nevertheless, although physicians and nurses are expected to provide patient care and improve their quality of life, their own needs and their own quality of life have been either largely underestimated or ignored.
Providing care in these cases is very demanding in physical, emotional, and spiritual terms. Their work requires certain qualities, such as empathy, compassion, and closeness to the individuals and families they care for. Therefore, daily work may be significantly influenced by the menopausal transition, especially in nurses and physicians Work is beneficial for menopausal women by providing fulfilment, self-esteem, identity and social needs. But working environments like those with lack of temperature control, cramped conditions, some uniforms and stress can also make menopause symptoms worse. Menopause refers to the time when a woman's menstrual period stops for 12 consecutive months after the last period and is characterized by a decline in the production of the ovarian hormones, mainly estrogen and progesterone. The lack of these hormones makes some women prone to experiencing common symptoms that include, but are not limited to, sleep disorders, mood alterations, hot flashes, depression, urinary tract infections, vaginal infections, and increased risk for osteoporosis and cardiovascular diseases. Providing up-to-date information to women about menopause, its management, and the use of menopausal hormone therapy (MHT) may serve as an important step towards treating postmenopausal symptoms thereby improving the QOL of postmenopausal women.
According to a recent study, the level of awareness and knowledge of women about the menopause is directly proportional to their ability to control their symptoms as menopausal symptoms can have a negative impact on work but menopause in the workplace still remains a taboo. This study aims to investigate the QoL of menopausal health-care providers in UMC hospitals in Nur-Sultan and identify whether there is a difference in the quality of life between two major groups of women health-care professionals: physicians and nurses, and to explore factors influencing on it.
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)
- We will include all menopausal health-care providers working in CAD of Women's Health and Pediatric CAD UMC, NCCR, and RDC, Nur-Sultan Kazakhstan. In order to get the highest possible response rate as well as evaluate the non-response bias, there is a need to follow-up to those who did not responded.
Key exclusion criteria (1 listed)
- Women with serious health problems, such as severe chronic diseases, including psychological/psychiatric comorbidities, and use of specific drugs for them, will not be included in the study
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 first part will assess the sociodemographic variables and reproductive characteristics, and the second part contain the Menopause-Specific Quality of Life (MENQOL) questionnaire The 29 questions of the MENQOL are divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). | Other | Study group |
Primary outcome
Menopause Quality of Life Measurement
Time frame: 36 month
The participants will be asked to indicate whether they had experienced symptoms or problems within the past month and, if so, to rate how bothersome they were on a seven-point Likert scale from 0 to 6: with 0 indicating that they were not at all bothered and 6 indicating that they were extremely bothered. The 29 questions of the MENQOL (supported by NCBI and NHI) are divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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, MD, PhD study director
Nazarbayev University Medical Center
Sanja Terzic, MD study director
Nazarbayev University Medical Center
Gauri Bapayeva, MD, PhD principal investigator
Nazarbayev University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, 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 27 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 Gauri Bapayeva, MD, PhD (+77017462800, gauri.bapaeva@umc.org.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). 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 27 Jan 2021.