Nursing Activity and Quality of Hospitalized Patients' Sleep (SOMACTIV)

The Impact of Night Nursing Activity on the Quality of Hospitalized Patients' Sleep

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 328

Contacts and Locations

• Study Contact: Name: Bridey Céline; Phone Number: +33383154081; Email: c.bridey@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized in a speciality medical units and who respond to the defined inclusion criteria. 5 units participate: nephrologye, neurology, cardiology, pneumology, endocrinology.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Part of patients declaring disturbing elements related to night nursing activity	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	At day 15 after inclusion
Disturbing elements related to night nursing activity	A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him	Every day during 15 days
Individual and clinical disturbing elements	A follow up sheet is completed every day by a study nurse who asks to patient what was the disturbing elements according to him	Every day during 15 days
Average length of patients' sleep in patients with troubled sleeping during hospitalization	Estimated with the Vis Morgen self administered questionnaire	Every day during 15 days
Sleep quality measured by Spiegel score	Score from 0 to 30	Every day during 15 days

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): August 15, 2019
• Study Completion (Anticipated): August 15, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2017-A02076-47

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