Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07919912

Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients

Conditions: Critical Illness, Pain, Procedural Anxiety

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 72
Sponsor: Sinop Atatürk State Hospital

Location: Sinop Atatürk State Hospital, Intensive Care Units Sinop

Summary

Bed bathing is a routine nursing procedure in the intensive care unit (ICU). In the study units, every patient routinely receives both a traditional bed bath with warm water and soap (every 10 days) and a bath with pre-packaged, disposable, no-rinse wipes (every 3 days). Little is known about how these two methods compare for pain, comfort and physiological stress in the same patient. The goal of this randomized crossover trial is to compare the two bathing methods within the same adult ICU patients. The main question it aims to answer is: Does pain-related behavior during the bath, measured with the Critical-Care Pain Observation Tool (CPOT) while the patient is turned to the side, differ between the soap-and-water bath and the wipe bath? Other questions include whether the methods differ in vital signs and body temperature after the bath, anxiety, comfort, feeling of cleanliness, satisfaction and preference in patients who can self-report, bath duration, nursing time, cost, and adverse events. The routine bathing schedule does not change. Only the order of each participant's first two study baths is decided by chance: either soap-and-water first and wipes 72 hours later, or wipes first and soap-and-water 72 hours later. Each patient serves as his or her own control. The first minute of the first lateral turn in both baths is video-recorded (face, upper body and arms only) and scored by an assessor who does not know which method was used.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Admitted to the second- or third-level adult ICU within the previous 48 hours and expected to stay at least another 24 hours * Richmond Agitation-Sedation Scale (RASS) score between -3 and +1 * Judged by the attending physician to be clinically suitable for a whole-body bed bath with two lateral turns * Hemodynamically stable: no vasopressor, or norepinephrine ≤ 0.1 µg/kg/min (or equivalent) without dose increase in the previous 6 hours * Written informed consent from the patient or the legal representative Exclusion Criteria: * RASS ≤ -4 or ≥ +2 * Use of neuromuscular blocking agents * End-of-life or exclusively palliative care * Severe neurological injury (brain death, Glasgow Coma Scale ≤ 8 not due to sedation) * Extensive skin damage (burns, widespread dermatitis, large open wounds) or known allergy to the wipe ingredients * Open abdomen, unstable spinal fracture, ECMO or any other condition preventing lateral turning * Initiation or dose change of anxiolytic or antipsychotic treatment within the previous 24 hours * Previous participation in this study within the last 30 days

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07919912). StuddyBuddy aggregates publicly available trial information.