NCT05378789

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

May 13, 2022

Last Update Submit

December 11, 2023

Conditions

Keywords

nap; ICU; nurse; Shift work

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

20-min nap

EXPERIMENTAL

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

Interventions

NapPROCEDURE

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.

20-min nap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier départemental Vendee

La Roche-sur-Yon, 85000, France

Location

Study Officials

  • Mélanie ROUGIER

    Centre hospitalier departemental Vendée

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

May 30, 2022

Primary Completion

July 15, 2023

Study Completion

August 31, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations