Patients' Sleep at the Intensive Care Unit

The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients.

Study Overview

• Status: Completed
• Conditions: Sleep Quality of ICU Patients
• Intervention / Treatment: Other: Richards-Campbell Sleeping Questionnaire (RCSQ)

Detailed Description

The main instrument of this research is the Richards Campbell Sleeping Questionnaire (RCSQ) regarding patients' overnight sleep quality. This questionnaire is given to complete to eligible patients between 7 am and 10 am. The same questionnaire is given to the night-shift nurse between 7 am and 7:30 am, who was taking care of that particular patient overnight. This RCQS assessment is based solely on each nurse´s perception of the patient´s sleep quality last night. Neither the nurse nor the patient know each other´s RCSQ response.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at intensive care units at the University Hospital Ostrava, Czech Republic fulfiling the inclusion criteria.

Description

Inclusion Criteria:

• ICU patients
• Age 18 years and older
• Glasgow coma scale 15

Exclusion Criteria:

• Age < 18 years
• Glasgow coma scale < 15

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 10 am.	Other: Richards-Campbell Sleeping Questionnaire (RCSQ); This five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.
Nurses; This study group will consist of patients hospitalized at ICU, who will be given the Richards-Campbell Sleeping Questionnaire (RCSQ) to fill in every morning between 7 am and 7:30 am.	Other: Richards-Campbell Sleeping Questionnaire (RCSQ); This five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-nurse inter-rater reliability	The inter-rater reliability between the evaluation of sleep quality performed by the patient and the nurse, as per Richards-Campbell Sleeping Questionnaire (RCSQ) score achieved, will be assessed. The RCSQ tool is used to assess a total of five dimensions pertaining to sleep, each of which is evaluated on a scale of 0 to 100.	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient sleep quality	The quality of patient sleep will be evaluated using the achieved Richards-Campbell Sleeping Questionnaire (RCSQ) scores. The RCSQ tool is used to assess a total of five dimensions pertaining to sleep, each of which is evaluated on a scale of 0 to 100.	30 weeks

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Kateřina Tejkalová, Mgr., University Hospital Ostrava

Publications and helpful links

General Publications

• Kamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
• Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: intensive care unit; sleep; nurse; patient; inter-rater reliability; Richards-Campbell sleeping questionnaire
• Other Study ID Numbers: FNO-KARIM-10-SLEEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The investigators have not decided to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No