Clinical trial NCT06620146: The Short-Term and Long-Term Effects of Providing Mechanical Bath in Terminally Ill Patients
Official title: The Short-Term and Long-Term Effects of Providing Mechanical Bath in Terminally Ill Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospice and Palliative Care Nursing
Terminally Ill Patients
Keywords: mechanical bathing
instrument validation
hospice care
comfort
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Physical comfort part-1
timeFrame: 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).
measure: Physical comfort part-2
timeFrame: Data collection occurs at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
measure: Agitation
timeFrame: 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).
measure: Physiological and psychological comfort
timeFrame: 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).
measure: Psychospiritual, sociocultural and environmental comfort
timeFrame: 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 outcomes:
measure: Emotional burden of family members
timeFrame: Data was collected at two points: baseline (within 1 week after admission, before first MB) and T3 (one week after baseline).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: