Clinical trial NCT05771909: Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers
Official title: Effect of App-driven Deep Breathing (NEURODIGITX) on Anxiety Levels and Quality of Life in Caregivers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Hospital Workers
Deep Breath
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The occurrence of the COVID-19 pandemic is associated with an increase in psychiatric illnesses (depression, anxiety) in the general population due to the infectious and vital risk involved, changes in social structure, particularly in the family environment, episodes of confinement, and even professional instability. These international phenomena have also been observed in France.

In addition to the constraints of the general population, health care workers have been, and continue to be, subject to other forms of constraints, linked to their professional activity. Indeed, the risk of viral exposure is for them major, the confrontation with the deaths of patients because of their fragility or the weakness of the care structures, are more violent in connection with their immediate reality. In addition, the workload due to health imperatives has also led to physical and psychological exhaustion of the health care teams. In addition to the international evidence, the existence and severity of the psychological consequences for health care workers have recently been documented at the local level in a survey conducted among the staff of the Groupe hospitalier Paris Saint-Joseph (GhPSJ). In this study of more than 780 people, nearly half of whom were in charge of patients infected with SARS-CoV2, 62% reported increased anxiety since the beginning of the epidemic, 41% had symptoms of anxiety, 21% had symptoms of depression and 14% had signs of post-traumatic stress. Approximately 25% of the total population had chosen to make regular use of the "bulle" (a decompression and care platform made available to staff since the first wave within the establishment) with the aim of reducing the anxiety generated by the situation and particularly by their professional activity. Given the importance of anxiety symptoms detected in healthcare professionals during the COVID-19 pandemic, the use of a simple, brief technique, requiring neither trained personnel nor expensive or difficult-to-access devices, aimed at reducing anxious stress could be of significant benefit to the population, especially to caregivers.

The objective of this study is to measure the effect of deep breathing on the anxiety of health professionals in the aftermath of the COVID-19 pandemic, and its effect on their quality of life. In order to measure the quality of the sessions, the breathing movements will be performed using a calibrated program and their immediate effectiveness will be evaluated by the variation of the heart rate, visible just after the program by the user.

The NeurodigitX® system offers to control interactive 3D games on a smartphone application through breath via a sensor connected to the phone by Bluetooth. This tool also allows to measure by plethysmography the heart rate variability in a simple and non-invasive way.

This system has been created as a preventive health solution by allowing everyone to measure, compare and share the activity of their Autonomic Nervous System (ANS) to better predict, understand, prevent and treat certain chronic diseases.


Eligibility criteria: Inclusion Criteria:

* Healthcareworkers whose age ≥ 18 years,
* Healthcareworkers working in the Emergency Department, Intensive Care Unit and/or visiting the Bulle at least once a week (frequency assessed by Delphi method) at Hôpital Paris Saint-Joseph, healthcareworkers visiting the Bulle at Hôpital Marie-Lannelongue at least once a week and healthcareworkers working at Hôpital Sainte-Marie or Hôpital Léopold Bellan
* French speaking staff
* Staff affiliated to the social security system or, failing that, to another health insurance system
* Staff who have given their free, informed and written consent

Exclusion Criteria:

* Current participation in another interventional study regarding post-traumatic stress or anxiety
* Regular practice in the last year of deep breathing techniques in the context of anxiety management (meditation, cardiac coherence, etc.)
* Use of medications that slow down the heart rate: antiarrhythmics, calcium channel blockers, beta-blockers.

Primary outcomes:
measure: Effect of a 3-month program of regular deep breathing practice on anxiety
timeFrame: Month 3
Secondary outcomes:
measure: Effect of the program on quality of life at 3 month
timeFrame: Month 3
measure: Effect of the program on quality of life at 6 month
timeFrame: Month 6
measure: Effect of the program on the evolution of heart rate variability at 3 month
timeFrame: Month 3
measure: Effect of the program by profession and department (emergency, intensive care, other department)
timeFrame: Day 1
measure: Effect of the program by profession and department (emergency, intensive care, other department)
timeFrame: Month 6
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hôpital Marie Lannelongue
city: Paris
country: France
facility: Hôpital Léopold BELLAN
city: Paris
country: France
facility: Hôpital Paris Saint-Joseph
city: Paris
country: France
facility: Hôpital Sainte-Marie
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Marguerite D'USSEL, MD
role: STUDY_DIRECTOR
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citation: d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e0267032. doi: 10.1371/journal.pone.0267032. eCollection 2022.
citation: d'Ussel M, Adam F, Fels A, Chatellier G, Philippart F. Characteristics of Hospital Workers Using a Wellbeing Center Implemented During the COVID-19 Pandemic to Prevent the Emotional Impacts of the Crisis. Front Public Health. 2022 Jul 4;10:913126. doi: 10.3389/fpubh.2022.913126. eCollection 2022.
citation: Lefevre H, Stheneur C, Cardin C, Fourcade L, Fourmaux C, Tordjman E, Touati M, Voisard F, Minassian S, Chaste P, Moro MR, Lachal J. The Bulle: Support and Prevention of Psychological Decompensation of Health Care Workers During the Trauma of the COVID-19 Epidemic. J Pain Symptom Manage. 2021 Feb;61(2):416-422. doi: 10.1016/j.jpainsymman.2020.09.023. Epub 2020 Sep 19.