Nursing Activity and Quality of Hospitalized Patients' Sleep

ID: NCT03370354
Status: Not yet recruiting
Phase: N/A
Start Date: February 01, 2018
First Submitted: November 30, 2017
Last Updated: December 06, 2017
Results: N/A
Sponsors & Collaborators: Central Hospital, Nancy, France, Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny and 3 more..
Location: N/A
Conditions: Sleep Disorders, Circadian Rhythm
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Study Description

Brief Summary

This study is to determine the impact of night shift nurse's activity on patients' sleeping patterns in medical services including individual, clinical and environmental factors. The patients will be questioned in order to create both a control group and a group with troubled sleeping patterns.

Detailed Description

There are 5 speciality medical units involved. Patients must respond to the define inclusion criteria. Each patient will be asked if they agree to participate and if so will be asked to consent to participate.

Every day, nurses will give a questionnaire which will be completed by the patient to know if there were troubles sleeping patterns. If so, a second questionnaire will be completed by the patient.

Other data will be recorded such as personal informations, diagnostic, medical history, consumption habits and treatments.

The inclusion phase lasts 15 days maximum.
Condition or disease Intervention/treatment Phase

Sleep Disorders, Circadian Rhythm

Behavioral: Observational
Other Names
N/A

Tracking Information

First Submitted DateNovember 30, 2017
Last Update Posted DateDecember 06, 2017
Anticipated Start DateFebruary 01, 2018
Anticipated Completion DateAugust 15, 2019
Anticipated Primary Completion DateAugust 15, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Presence of a sleeping disorder partially or totally related, according to patient's opinion, to night nursing activity [Time Frame: At the end of participation of patient- maximum at day 15 after inclusion]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Part of patients declaring disturbing elements related to night nursing activity [Time Frame: At day 15 after inclusion]

    A follow up sheet is completed every day by a study nurse who asks to patient if the patient sleeps well during the previous night

  • Disturbing elements related to night nursing activity [Time Frame: Every day during 15 days]

    A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him

  • Individual and clinical disturbing elements [Time Frame: Every day during 15 days]

    A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him

  • Average length of patients' sleep in patients with troubled sleeping during hospitalization [Time Frame: Every day during 15 days]

    Estimated with the Vis Morgen self administered questionnaire

  • Sleep quality measured by Spiegel score [Time Frame: Every day during 15 days]

    Score from 0 to 30

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleNursing Activity and Quality of Hospitalized Patients' Sleep
Official TitleThe Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep
Brief Summary

This study is to determine the impact of night shift nurse's activity on patients' sleeping patterns in medical services including individual, clinical and environmental factors. The patients will be questioned in order to create both a control group and a group with troubled sleeping patterns.

Detailed Description

There are 5 speciality medical units involved. Patients must respond to the define inclusion criteria. Each patient will be asked if they agree to participate and if so will be asked to consent to participate.

Every day, nurses will give a questionnaire which will be completed by the patient to know if there were troubles sleeping patterns. If so, a second questionnaire will be completed by the patient.

Other data will be recorded such as personal informations, diagnostic, medical history, consumption habits and treatments.

The inclusion phase lasts 15 days maximum.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
328
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Sleep Disorders, Circadian Rhythm
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodProbability Sample
Study PopulationPatients hospitalized in a speciality medical units and who respond to the defined inclusion criteria. 5 units participate: nephrologye, neurology, cardiology, pneumology, endocrinology.
Intervention
Behavioral: Observational

Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.

Other Names
Study Groups/Cohorts
Control group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is > 18, the patient will be in the control group.

troubled sleeping patterns group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is < 18, the patient will be in the troubled patterns group.

Study Arms
troubled sleeping patterns group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is < 18, the patient will be in the troubled patterns group.
Behavioral : Observational
Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.

Arm Intervention/Treatment
troubled sleeping patterns group
First questionnaire (spiegel questionnaire) will allow a score on 30. If the score is < 18, the patient will be in the troubled patterns group.
Behavioral : Observational

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment328
Completion DateAugust 15, 2019
Eligibility Criteria: Inclusion Criteria:
- Patient hospitalize in medical units
- In the unit since one night
- Patient over 18 years old
- Patient agree to participate

Exclusion Criteria:
- Patient who can't answer to the questionnaire for health reasons
- Patient who need a specific surveillance
- Patient recently operated
GenderAll
Age18 Years to 99 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03370354
Other Study ID Numbers
2017-A02076-47
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Central Hospital, Nancy, France
Collaborators
Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein
Investigators
Principal Investigator
Bridey Céline
CHRU Nancy France