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NCT Number: NCT06775210

Effect of Implementing Sleep Care Bundle on 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

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Key information

Conditions

Respiratory Ilness Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

supportive sleep care

Other

sleep bundle

Care bundle

Other

sleep bundle

Primary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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