COVID-19NCT06309186
Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19
An observational study of COVID-19, run by IRCCS Burlo Garofolo at 2 sites in Italy.
Trial summary
As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Evaluation of midwifes' burnout
- How many people
- 64 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Jan 2023to 31 Dec 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Midwives
Who may be able to join
- Midwives registered in the orders of Friuli Venezia Giulia (FVG) region
- Midwives in practice for at least one year
- Midwives practicing in FVG region
Who cannot join
- Consent not granted
- Midwives in retirement for more than a year
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Martina Debelli, martina.debelli@burlo.trieste.it
- Recruiting
Ordine delle ostrtriche di Trieste e Gorizia
Trieste
Giuseppa Verardi, info@ordineostetrichetsgo.com
About this study
Official title: Empowerment and Burnout of Midwives at the End of Health Emergency From SARS-CoV2: a Cross-sectional Observational Study in Friuli-Venezia Giulia Region
As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations.
- Conditions
- COVID-19
- Being tested
- Evaluation of midwifes' burnout
- Keywords
- Midwifery, Empowerment, Burnout
- Medical subject headings
- COVID-19, Empowerment, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of midwifes' burnoutOther
Burnout evaluated by questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Midwives | The study involves a convenience sample of midwives registered with the two Orders of the Midwifery Profession in Friuli-Venezia Giulia Region (Italy) Receives: Other: Evaluation of midwifes' burnout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of empowerment of midwives
Midwives empowerment will be evaluated with the italian validated version of the "Perceptions of empowerment in midwifery scale-revised" (PEMSR). It consists of 19 items, expressing 4 subscales divided into four subscales: autonomy/empowerment (4 items); manager support (5 items); professional recognition (5 items); and skills and resources (5 items). Total scores are calculated for each of the subscales by summing all the scores from each item, and then dividing by the number of items in the same subscale. Scores range from 1 (low level of empowerment), to 5 (high level of empowerment).
Measured: At enrolment
Number of midwives affected by burnout
Burnout will be evaluated with the Maslach Burnout Inventory (MBI), an instrument of 22 Likert items of 7 points on feelings related to work. Respondents rate how often they experience these feelings on a 7-point Likert scale from 0 (never) to 6 (every day). The MBI includes 3 subscales or dimensions: emotional exhaustion (EE), depersonalization (DP, and personal accomplishment (PA). Higher item scores in EE and DP and low in PA correspond to high levels of burnout.
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start9 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309186
- Sponsor's protocol ID
- RC 30/2023
- Status last verified
- Jun 2024
- First submitted
- 12 Mar 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowerment and Burnout of Midwives at the End of Health Emergency From SARS-CoV2: a Cross-sectional Observational Study in Friuli-Venezia Giulia Region
- ClinicalTrials.gov ID
- NCT06309186
- Acronym / sponsor ID
- RC 30/2023
- Conditions
- COVID-19
- Keywords
- Midwifery, Empowerment, Burnout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midwives | – | Other: Evaluation of midwifes' burnoutThe study involves a convenience sample of midwives registered with the two Orders of the Midwifery Profession in Friuli-Venezia Giulia Region (Italy) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Midwives
Key inclusion criteria (3 listed)
- Midwives registered in the orders of Friuli Venezia Giulia (FVG) region
- Midwives in practice for at least one year
- Midwives practicing in FVG region
Key exclusion criteria (2 listed)
- Consent not granted
- Midwives in retirement for more than a year
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 |
|---|---|---|
| Evaluation of midwifes' burnoutBurnout evaluated by questionnaires | Other | Midwives |
Primary outcome
Evaluation of empowerment of midwives
Time frame: At enrolment
Midwives empowerment will be evaluated with the italian validated version of the "Perceptions of empowerment in midwifery scale-revised" (PEMSR). It consists of 19 items, expressing 4 subscales divided into four subscales: autonomy/empowerment (4 items); manager support (5 items); professional recognition (5 items); and skills and resources (5 items). Total scores are calculated for each of the subscales by summing all the scores from each item, and then dividing by the number of items in the same subscale. Scores range from 1 (low level of empowerment), to 5 (high level of empowerment).
Number of midwives affected by burnout
Time frame: At enrolment
Burnout will be evaluated with the Maslach Burnout Inventory (MBI), an instrument of 22 Likert items of 7 points on feelings related to work. Respondents rate how often they experience these feelings on a 7-point Likert scale from 0 (never) to 6 (every day). The MBI includes 3 subscales or dimensions: emotional exhaustion (EE), depersonalization (DP, and personal accomplishment (PA). Higher item scores in EE and DP and low in PA correspond to high levels of burnout.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by IRCCS Burlo Garofolo at 2 sites in Italy.
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 3 inclusion and 2 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Debelli (+393204389187, martina.debelli@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of empowerment of midwives (time frame: At enrolment). The study lists 2 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 13 Jun 2024.