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

• Sponsor: Centre Hospitalier Departemental Vendee (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05378789
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Nap	Procedure: Nap	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review
• Actual Study Start Date: May 30, 2022
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Nap appropriation [12 months after baseline]

   Proportion of the number of nights worked with micro-naps to the number of nights worked by a caregiver over a year.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier départemental Vendee	La Roche-sur-Yon		France	85000

Sponsors and Collaborators

• Centre Hospitalier Departemental Vendee

Investigators

• Principal Investigator: Mélanie ROUGIER, Centre hospitalier departemental Vendée

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Departemental Vendee
• ClinicalTrials.gov Identifier: NCT05378789
• Other Study ID Numbers: CHD21_0119
• First Posted: May 18, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Departemental Vendee: nap; ICU; nurse; Shift work

Study Results

No Results Posted as of Jun 14, 2022