Nursing Activity and Quality of Hospitalized Patients' Sleep

Sleep Disorders, Circadian Rhythm Clinical Trial

— SOMACTIV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03370354
• Other study ID #: 2017-A02076-47
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 6, 2017
• Start date: February 1, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: December 2017
• Source: Central Hospital, Nancy, France
• Contact: Bridey Céline
• Phone: +33383154081
• Email: c.bridey[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Professeur Pierre-Yves Marie, Cédric Baumann, Katie Galois, Romuald Zadra, Virginie Simon, Martine Lesny, Edith Dauchy, Saliha Sammari, Sylvie Klein

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sleep quality measured by Spiegel score	Score from 0 to 30	Every day during 15 days