Providing mechanical bathing (MB) is a commonly used strategy to maintain cleanness and comfort in patients with terminally illness. However, extra devices, costs, and human resources are required for such service. There is also a lack of evidence systematically examining the benefits of using MB. These extra financial and resource burden and insufficient evidence limit the use of MB in hospice clinical settings. The aim of this study is to examine whether more frequent MB can improve hospice patients' and their caregivers' comfort. The study has two phases. The first preparation phase is for questionnaire translation and piloting. The second phase is a randomized controlled trail in which adult hospice patients admitted to a hospice unit will be randomly assigned to intervention or control group. Participants in the intervention group will be provided MB every other day for a week while participants in the control group receive routine care (using MB once a week). The primary outcome is patients' level of comfort as measured by questionnaire and physical indicators. The secondary outcome is caregivers' emotional burden. Data collection will occur before, during, and after the intervention. The estimation sample sizes for the two phases are 200-250 and 80, respectively. Descriptive analysis and generalized estimating equations will be employed to analyze data. The results of this study will fully recognize the short-term and long-term effects of MB. This understanding can then serve as a foundation to standardize the frequency of providing MB and justify for the resources needed for providing MB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
245
Providing mechanical bathing (MB) is a commonly used strategy to maintain cleanness and comfort in patients with terminally illness. The electric medical bathtub (ARJO, Rhapsody) provides functions such as showering, bathing, and water massage. The MB will be operated by 2-3 nursing staff, trained hospice volunteers, or researchers. Each patient\'s MB process lasts about 20 minutes, including washing the hair and body with a handheld showerhead, followed by soaking in warm water for about 5-10 minutes. Based on the patient preference, the water temperature is adjusted between 38 to 40 degrees Celsius.
National Taiwan University Hospital
Taipei, Taiwan
Physical comfort part-1
Physical comfort part-1 scale is assessed by two domains, including vital signs and pitting edema level. Vital signs contains temperature, heart rate, respiratory rate and blood pressure. Pitting edema is evaluated by grade +1 to +4, higher score means significant level of edema.
Time frame: Data collection occurs at four points: baseline (within 1 week after admission, before first MB), T1 (within 2 hrs after second MB), T2 (within 2 hrs after third MB), and T3 (one week after baseline).
Physical comfort part-2
Physical comfort part-2 is assessed by pain and infection incidence. In the pain assessment, numerical rating scale and analgesic usage are for subjective and objective pain, respectively. Infection incidence is identified by new positive cultures, fever with a suspected source, new antibiotics, or abnormal markers such as C-reaction protein, white blood cell count and procalcitonin.
Time frame: Data collection occurs at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
Agitation
Agitation is assessed by Richmond Agitation Sedation Scale, which abbreviated as RASS, grading from -5 to +4, zero point means alert but calm. Higher scores means intense agitation and lower scores means stupor/drowsiness.
Time frame: Data collection occurs at four points: baseline (within 1 week after admission, before first MB), T1 (within 2 hrs after second MB), T2 (within 2 hrs after third MB), and T3 (one week after baseline).
Physiological and psychological comfort
Physiological and psychological comfort is assessed by symptoms (Edmonton Symptom Assessment System, ESAS), which have 11 items including physical and mental that grading from 1 to 10 points of each question. Higher scores means more symptoms.
Time frame: Data collection occurs at four points: baseline (within 1 week after admission, before first MB), T1 (within 2 hours after second MB), T2 (within 2 hours after third MB), and T3 (one week after baseline).
Psychospiritual, sociocultural and environmental comfort
Psychospiritual comfort is measured by the Hospice Comfort Questionnaire (HCQ), which have 24 items rating from 1 to 6 points of each question, higher level means less uncomfortable. Moreover, the HCQ assessment also covers sociocultural and environmental comfort.
Time frame: Data collection occurs at four points: baseline (within 1 week after admission, before first MB), T1 (within 2 hrs after second MB), T2 (within 2 hrs after third MB), and T3 (one week after baseline).
Emotional burden of family members
Emotional burden of family members, will be measured using the Mood Thermometer (Brief Symptom Rating Scale, BSRS-5), rating from 0-4 points of each item. A higher total score of BSRS-5 indicates a higher emotional burden of the family member.
Time frame: Data was collected at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
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