The Short-Term and Long-Term Effects of Providing Mechanical Bath in Terminally Ill Patients

The Short-Term and Long-Term Effects of Providing Mechanical Bath in Terminally Ill Patients: A Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Hospice and Palliative Care Nursing; Terminally Ill Patients
• Intervention / Treatment: Other: mechanical bathing

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years of age
• Diagnosed by a physician as having a terminal illness and currently receiving treatment in the palliative care unit of National Taiwan University Hospital
• Unable to clean oneself
• Willing to receive MB
• Has not received any MB during this hospital stay
• If the caregiver will be responsible for caring for the patient throughout the study period, will also be invited to participate in the study

Exclusion Criteria:

• The patient, due to physical, consciousness, or cognitive impairments, is unable to self-assess their symptoms, and there is no primary caregiver available during the study period to assist in evaluating their symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group provided with mechanical bathing every other day for a week; Participants in the intervention group will be provided mechanical bathing every other day for a week.	Other: mechanical bathing; 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.
No Intervention: control group provided with routine care (mechanical bathing once a week); control group receive routine care (using mechanical bathing once a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Data was collected at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: comfort; hospice care; instrument validation; mechanical bathing
• Other Study ID Numbers: 202207077RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No