NCT06309186

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

March 12, 2024

Last Update Submit

June 12, 2024

Conditions

Keywords

MidwiferyEmpowermentBurnout

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Midwives

The study involves a convenience sample of midwives registered with the two Orders of the Midwifery Profession in Friuli-Venezia Giulia Region (Italy)

Other: Evaluation of midwifes' burnout

Interventions

Burnout evaluated by questionnaires

Midwives

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Midwives

You may qualify if:

  • Midwives registered in the orders of Friuli Venezia Giulia (FVG) region
  • Midwives in practice for at least one year
  • Midwives practicing in FVG region

You may not qualify if:

  • Consent not granted
  • Midwives in retirement for more than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Ordine delle ostrtriche di Trieste e Gorizia

Trieste, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19EmpowermentBurnout, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehaviorStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 13, 2024

Study Start

January 9, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations