FoCo: Evaluating a Training to Increase Attention and Awareness of Healthcare Professionals

NCT04362397 | Completed DMC

• 1 other identifier: HIAE_FoCo
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: A significant increase in the risk of injury and illness at work has been associated with fatigue, stress, haste, distraction, emergency situations, excessive noise, complex procedures and anger among other factors. Most of these factors are related to the lack of attention to work in progress, which can be improved by training attention and awareness during daily activities, as it would encourage a resumption of focus on the task at hand and the possible risks associated with it. . The primary objective of this project is to evaluate the effects of training to increase attention and awareness for daily activities - FoCo - outlined for healthcare professionals in their work schedule. Method: Health professionals from 18 to 60 years of age, of both sexes, will participate in the study, working in 3 units, one in the care of patients in a Emergency Care Unit (UPA), in an Elderly Residential and in a Center. Intensive Care (ICU). In the UPA will be included 25 professionals in group A and 25 in group B; In the Residential of Elderly, 40 professionals will be included in group A and 40 professionals in group B; In the ICU will be included 30 professionals in group A and 30 in group B. They will be randomized in both groups. Group A will receive training in the FoCo program and group B will be a waiting group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives (Fig.1). Participants will be evaluated before, after one month and after two months. Expected Outcomes: After training, an increase in mindful, attention and awareness scale, self-compassion scale, positive affect, speed of digit and symbol test is expected. It is also expected to reduce negative affects, perceived stress and an increased perception of possible incidents.

Conditions

Attention; Self-compassion

Outcome Measures

Primary Outcomes (2)

• change in stress

  The authors will evaluate attention using the MAAS (Mindful Attention Awareness Scale).

  1 month

• change in attention

  The authors will apply the Perceived Stress Scale

  1 month

Secondary Outcomes (4)

• change in self-compassion

  1 month

• change in sleep

  1 month

• change in Mental health symptoms

  1 month

• change in positive and negative affect

  1 month

Study Arms (2)

A (first group to receive the intervention)

EXPERIMENTAL

This arm will receive the attention, care, and self-care training first.

Behavioral: FoCo; Behavioral: No intervention

B (second group to receive the intervention)

EXPERIMENTAL

This arm will not receive intervention in the first month and will receive it after this period.

Behavioral: FoCo; Behavioral: No intervention

Interventions

FoCo BEHAVIORAL

This is an attention, care and self-care training.

A (first group to receive the intervention); B (second group to receive the intervention)

No intervention BEHAVIORAL

This is a waiting list

A (first group to receive the intervention); B (second group to receive the intervention)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be available to participate in the training and to perform the evaluations before and after it.

You may not qualify if:

• \- being away or on vacation during the research project, being in psychiatric treatment.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

Study Officials

• Elisa H Kozasa, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator responsible for the statistical analysis will be blind to the groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A will receive training in the FoCo program and group B will be a waiting list group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: April 24, 2020
• Study Start: August 20, 2019
• Primary Completion: May 20, 2020
• Study Completion: December 20, 2020
• Last Updated: February 11, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)