Effect of Implementing Sleep Care Bundle on Nurses' Practice and Patients' Outcomes

January 9, 2025 updated by: Ayat Mohamed Fahmy Mohamed Elsheikha, Mansoura University

The Effect of Implementing Sleep Care Bundle on Critical Care Nurses' Practice and Patients' Outcomes

Sleep is a fundamental physiological requirement for the human body to heal and overcome an illness or injury . Good sleep is essential for patient recovery and restoration of normal daily functions . Critically ill patients often experience poor sleep quality due to shortened sleep times, increased daytime sleep, and disrupted circadian rhythm . Poor sleep quality is one of the most common complaints of patients who survive their critical illness. Patients' complaints include trouble initiating and maintaining sleep and frequent awakenings with difficulty returning to sleep

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sleep plays an important role in restoring the health of individuals who are ill or injured and essential for critical illness recovery. Poor sleep quality during hospitalization may lead to post-hospital symptoms and increase readmission rates and mortality . Sleep disruption is associated with immune system dysfunction, decreased resistance to infection, changes in nitrogen balance, and impaired wound healing. Therefore, using a standardized non-pharmacological sleep promotion strategy as a sleep care bundle is proposed to reduce the incidence of delirium and improve sleep quality. Internationally, investigations performed to evaluate the effect of implementing sleep care bundle on patients' outcomes had reported its effectiveness. However, studies that addressed the effectiveness of implementing sleep care bundle on critical care nurses' practice and patients' outcomes in Egypt are scarce. Moreover, from our empirical observations, investigators found that there are no available standards of sleep care in the study setting. Furthermore, most nurses do not realize the importance of good sleep for critically ill patients. Therefore, the present study will be carried out to address this issue. Hopefully, the current investigation might generate attention and motivation for using this bundle and for conducting further research studies in this area.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Mansoura, Dakahlia Governorate, Egypt, 35516
        • Faculty of Nursing, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Inclusion criteria

  • Adult patients of ≥ 18 years old.
  • Fully consciousness (Glasgow coma scale score 15; orientation to person, place, and time).
  • Spent at least 3 full nights in the above-mentioned ICUs.

Exclusion Criteria:

History of sleep disorder as insomnia and sleep apnea.

  • History of mental disorders.
  • Patients who are on sedative or narcotic drugs.
  • Patients who have visual or hearing impairment.
  • History of skin diseases (e.g., contagious skin, eczema).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bundle group
receive sleep bundle at sleep
Other: care bundle
sleep bundle
Placebo Comparator: Control group
receive routine care
Other: supportive sleep care
sleep bundle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Quality Assessment Scale
Time Frame: from first day on admission to three days
This part used to measure patients' sleep quality. This instrument was developed and validated for ICU patients. It measures participants' perceptions of their sleep in five dimensions: sleep depth, sleep latency (time to fall a sleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. Answers are recorded on a visual analogue scale of 100 mm, with higher scores representing better sleep
from first day on admission to three days
Sleep Care Bundle Observation Checklist
Time Frame: Each participant nurse was interviewed individually to gather the demographic characteristics. Nurses' practices regarding the sleep care bundle were observed .
This part will be developed by the researcher after revising related literature. It will be used to assess nurses' practice regarding implementing the sleep care bundle which encompasses three main domains including; seeing, sensing, and hearing. The intervention that is done correctly will be scored with 1 point while the item that is done incorrectly or not done will be scored with zero point.
Each participant nurse was interviewed individually to gather the demographic characteristics. Nurses' practices regarding the sleep care bundle were observed .
Intensive Care Delirium Screening Checklist (ICDSC)
Time Frame: from first day on admission to three days

This part was adopted from Bergeron, Dubois, Dumont, Dial, & Skrobik (2001) to assess ICU-acquired delirium. Designed for rapid observations from bedside clinical staff routinely gathered throughout a shift. The ICDSC is composed of 8 items including; altered level of consciousness, inattention, disorientation, hallucination or delusion, psychomotor agitation or retardation, inappropriate mood or speech, sleep/wake cycle disturbance, and symptom fluctuation. Patients scored one point for each symptom exhibited during the study and zero points if the symptom did not present.

The score is ranked as follows:

  • A 0 score indicates that the patient has no delirium
  • A score from 1-3 indicates sub-syndromal delirium
  • A score from 4-8 indicates delirium
from first day on admission to three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sleep Care Bundle

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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