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

June 10, 2025 updated by: National Taiwan University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical comfort part-1
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-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
Time Frame: Data collection occurs at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
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
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).
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
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).
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
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotional burden of family members
Time Frame: Data was collected at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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