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

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National Taiwan University

Status

Completed

Conditions

Terminally Ill Patients
Hospice and Palliative Care Nursing

Treatments

Other: mechanical bathing

Study type

Interventional

Funder types

Other

Identifiers

NCT06620146
202207077RINB

Details and patient eligibility

About

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.

Enrollment

245 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

245 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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