Can a comfort care bundle ease ICU stress?
NCT ID NCT07366021
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a comfort care bundle for ICU patients. The bundle includes physical, emotional, and environmental support from nurses. 88 patients in Turkey will either get standard care or the comfort bundle. The goal is to see if it improves comfort and vital signs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Comfort Care Bundle (behavioral intervention)
- What this could lead to
- If it works, this could provide a simple, nurse-led approach to improve comfort and reduce stress for ICU patients.
- What could go wrong
- This is a small, single-center study with only 88 patients. Results may not apply to all ICUs, and comfort is subjective and hard to measure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Staying in the intensive care unit for at least 48 hours * Communication language being Turkish * For non-intubated patients, GCS \> 12; for intubated patients, GCS \> 10 + intubated (verbal response) Exclusion Criteria: * Hearing and hearing problems * History or diagnosis of cognitive impairment, mental illness, nervous system disorders, brain injury * RASS score \>1 * Delirium * Admitted with a diagnosis of alcohol/drug intoxication * Pregnant * Hemodynamically unstable patients receiving high-dose inotropic/vasopressor drug therapy * Transfer to another ICU * Emergency discharge from the ICU for any reason
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Akdeniz University
Antalya, Turkey (Türkiye)
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Other studies related to the condition(s) this trial covers.
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