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

Design: Single-center, prospective, randomized, two-period, two-sequence (wash-wipe / wipe-wash) crossover trial embedded in routine care, with blinded video-based assessment of the primary outcome. Setting: second-level (16 beds) and third-level (22 beds) adult ICUs, Sinop Atatürk State Hospital, Türkiye.

Routine care and schedule: All ICU patients routinely receive a whole-body soap-and-water bed bath every 10 days and a whole-body disposable wipe bath every 3 days. In the study, Session 1 is given within 24 hours after randomization with the method determined by the allocated sequence, and Session 2 is given with the other method 72 hours (±12 hours) later, which matches the routine 3-day interval. Thereafter, the routine schedule continues (soap-and-water every 10 days from the first wash; wipes every 3 days; if both fall on the same day, only the soap-and-water bath is given). Routine oral and perineal care continues. Additional baths are allowed when clinically needed.

Randomization: Sequences are allocated 1:1 using computer-generated lists with permuted blocks of 4 and 6, stratified by ICU level and communication status (Stratum A: able to self-report - RASS -1 to +1, CAM-ICU negative, able to use a visual analogue scale; Stratum B: unable to self-report). Allocation is concealed with sequentially numbered, opaque, sealed envelopes.

Interventions: Both methods cover the whole body in the same clean-to-dirty order with two lateral turns, two nurses, privacy measures, linen change and a standardized information script. Soap-and-water bath: warm water (43.5-46 °C), liquid soap, separate cloths and towels; each area is soaped, rinsed and towel-dried. Wipe bath: chlorhexidine-free, no-rinse disposable wipes warmed to ≤40 °C; a new wipe for each area, at least three passes with light pressure, air-dried.

Measurements: Full measurements are made in Sessions 1 and 2 at T0 (before the bath after ≥15 minutes of rest), during the bath, T1 (10 minutes after), T2 (30 minutes after) and during the 2 hours after the bath. CPOT and vital signs are recorded in all patients; Stratum A patients also rate anxiety (VAS-A), comfort, cleanliness and satisfaction, and state their preferred method after Session 2. For later routine baths, date, method, duration, materials and adverse events are recorded; skin is assessed at baseline, at each soap-and-water bath and at ICU discharge (descriptive only, because every patient receives both methods).

Blinding: The first minute of the first lateral turn in Sessions 1 and 2 is video-recorded with a hospital-owned, password-protected device (face, upper body and arms; ventilator screen in intubated patients; bathing materials and genital area excluded). Videos are coded without method or session information and scored in random order by an assessor not involved in bathing. The muscle tension item is taken from the in-room nurse. If no video is available, the in-room CPOT score is used. Videos are deleted after scoring.

Sample size: Assuming a clinically relevant within-patient difference of 1 CPOT point and a standard deviation of differences of 2.0 (dz = 0.5), two-sided alpha 0.05 and 80% power, 34 patients completing both sessions are required. Allowing about 15% loss before Session 2, 40 patients will be randomized.

Statistical analysis: Procedural CPOT will be analyzed with a linear mixed model including method, period, sequence and session-specific resting CPOT as fixed effects and patient as a random effect, adjusted for ICU level and stratum; all randomized patients contribute available data. Sensitivity analyses: Wilcoxon signed-rank test with Hodges-Lehmann estimate in completers, in-room scores, video-only sessions, adjustment for sedative infusions, and an ordinal mixed model. Secondary outcomes are analyzed with mixed models, McNemar tests or exact binomial test (preference), and interpreted as exploratory.

Safety: The bath is stopped if SpO2 < 90% for >1 minute, MAP < 65 mmHg or >20% fall, heart rate >130 or <50/min or new arrhythmia, RASS ≥ +2, tube or catheter displacement, or at the patient's request.