Respiratory IlnessNCT06775210
Effect of Implementing Sleep Care Bundle on Nurses' Practice and Patients' Outcomes
A study testing supportive sleep care and care bundle in people with Respiratory Ilness and Respiratory Distress Syndrome, Adult, run by Mansoura University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Respiratory Ilness, Respiratory Distress Syndrome, Adult
- What is being tested?
- supportive sleep care and care bundle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Nursing, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: 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
Read the 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.
- Being tested
- supportive sleep care, care bundle
- Keywords
- sleep care bundle, nursing practice, patients outcomes
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supportive sleep careOther
sleep bundle
care bundleOther
sleep bundle
| Study group | Role | What they receive |
|---|---|---|
| bundle group | Experimental | receive sleep bundle at sleep Receives: Other: care bundle |
| Control group | Placebo comparator | receive routine care Receives: Other: supportive sleep care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: from first day on admission to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory IlnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Mohamed Fahmy Mohamed Elsheikha, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775210
- Sponsor's protocol ID
- Sleep Care Bundle
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Implementing Sleep Care Bundle on Critical Care Nurses' Practice and Patients' Outcomes
- ClinicalTrials.gov ID
- NCT06775210
- Acronym / sponsor ID
- Sleep Care Bundle
- Keywords
- sleep care bundle, nursing practice, patients outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bundle group | Experimental | Other: care bundlereceive sleep bundle at sleep |
| Control group | Placebo comparator | Other: supportive sleep carereceive routine care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supportive sleep caresleep bundle | Other | Control group |
| care bundlesleep bundle | Other | bundle group |
Primary outcome
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supportive sleep care and care bundle in people with Respiratory Ilness and Respiratory Distress Syndrome, Adult, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Assessment Scale (time frame: from first day on admission to three days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.