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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06309186
Other study ID # RC 30/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 9, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source IRCCS Burlo Garofolo
Contact Martina Debelli
Phone +393204389187
Email martina.debelli@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: 1. Midwives registered in the orders of Friuli Venezia Giulia (FVG) region 2. Midwives in practice for at least one year 3. Midwives practicing in FVG region Exclusion Criteria: 1. Consent not granted 2. Midwives in retirement for more than a year

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation of midwifes' burnout
Burnout evaluated by questionnaires

Locations

Country Name City State
Italy Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" Trieste

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). At enrolment
Primary 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. At enrolment
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