SOMACTIV: Nursing Activity and Quality of Hospitalized Patients' Sleep

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03370354
Collaborator
Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein (Other)
328
18.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Observational

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 Design

Study Type:
Observational
Anticipated Enrollment :
328 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep
Anticipated Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Aug 15, 2019
Anticipated Study Completion Date :
Aug 15, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Part of patients declaring disturbing elements related to night nursing activity [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

  2. Disturbing elements related to night nursing activity [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

  3. Individual and clinical disturbing elements [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

  4. Average length of patients' sleep in patients with troubled sleeping during hospitalization [Every day during 15 days]

    Estimated with the Vis Morgen self administered questionnaire

  5. Sleep quality measured by Spiegel score [Every day during 15 days]

    Score from 0 to 30

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT03370354
Other Study ID Numbers:
  • 2017-A02076-47
First Posted:
Dec 12, 2017
Last Update Posted:
Dec 12, 2017
Last Verified:
Dec 1, 2017
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2017