Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review (MARIENAIE)

MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published.

This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).

Study Overview

• Status: Completed
• Conditions: Nap
• Intervention / Treatment: Procedure: Nap

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: stéphanie MARTIN; Phone Number: +33 02 51 44 64 83; Email: stephanie.martin@ght85.fr

Study Locations

• France
  • La Roche-sur-Yon, France, 85000
    • Centre Hospitalier Départemental VENDEE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center.

Exclusion Criteria:

• Pregnant woman.
• Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project.
• Caregiver refusing to participate in the project.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-min nap; ICU nurses can take a 20-minute nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair.	Procedure: Nap; ICU nurses can take a 20-mn nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nap appropriation	Proportion of the number of nights worked with micro-naps to the number of nights worked by a caregiver over a year.	12 months after baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Mélanie ROUGIER, Centre Hospitalier Départemental VENDEE

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: nap; ICU; nurse; Shift work
• Other Study ID Numbers: CHD21_0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No