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

NCT ID: NCT06620146

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2024-09-27

Brief Summary

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.

Conditions

Hospice and Palliative Care Nursing; Terminally Ill Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mechanical bathing

Intervention Type: OTHER

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.

control group provided with routine care (mechanical bathing once a week)

control group receive routine care (using mechanical bathing once a week)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202207077RINB

Identifier Type: -

Identifier Source: org_study_id