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

NCT06775210 | Completed

• 1 other identifier: Sleep Care Bundle
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Ilness; Respiratory Distress Syndrome, Adult

Keywords

sleep care bundle; nursing practice; patients outcomes

Outcome Measures

Primary Outcomes (3)

• Sleep Quality Assessment Scale

  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

  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)

  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

Study Arms (2)

bundle group

EXPERIMENTAL

receive sleep bundle at sleep

Other: care bundle

Control group

PLACEBO COMPARATOR

receive routine care

Other: supportive sleep care

Interventions

supportive sleep care OTHER

sleep bundle

Control group

care bundle OTHER

sleep bundle

bundle group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Patient Care Bundles

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 15, 2025
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 25, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

EG (1)