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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03251274
Other study ID # CMUH105-REC3-138
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2017
Est. completion date December 31, 2018

Study information

Verified date March 2020
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is divided into two stages, the purposes of the first stage are (1) to examine the feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to examine the safety and comfortability of the bathtub machine from the perspectives of the nurse aides. The purposes of the second stage are (1) to understand the experiences of nurse aides and the elderly with disability by using the bathtub machine(which has edde massage function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep quality and body temperature in the elderly with disability.


Description:

The trends of bath disability in elderly consistently increased and, enhance, the demand of helping bath for the elderly also increased in Taiwan. Bathing is an important item of activities of daily living for human. Bathing not only keeps the body clean but also makes body comfort. Some studies showed that taking hot (40-40.5°C) baths 1.5 - 2 hours before bedtime resulted in a significant increase slow wave sleep (SWS) in the early part of the sleep period and improving sleep continuity in older female insomniacs.

Nurse aides are one of important human resource for long-term care institution. In Taiwan, Chao et al. reported that nurse aides had long-term accumulating discomfort over neck, shoulders and lower back during helping disable residents to carry out activity daily life. However, the body discomfort in nurse aides significantly decreased by using auxiliary equipment during assisting the elderly to carry out activity daily life. Therefore, it is important to use auxiliary equipment to prevent injury during work for nurse aides.

This study is interested in applying edde massage bathtub to improve sleep quality for disable residents in long-term care institutions. The study is divided into two stages, first stage of the study is to train nurse aides to use the bathtub machine (which has edde massage function) and solicits the opinions of nurse aides about factors related to the accessibility and safety of bath-tub machine using focus group methods. The purposes of the first stage study are (1) to examine the feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to examine the safety and comfortability of the bathtub machine from the perspectives of the nurse aides.

Second stage of the study is to explore the experiences of nurse aides and disabled elderly by using the bathtub machine. The purposes of the second stage study are (1) to understand the experiences of nurse aides and the elderly with disability by using the bathtub machine(which has edde massage function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep quality and body temperature in the elderly with disability.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 31, 2018
Est. primary completion date September 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- More than half a year in the institution

- 18 years of age (including) or above, with the help of bathing

- Be conscious, able to listen, speak Chinese

Exclusion Criteria:

- Acute illness

- Diabetes

- Peripheral blood vessels or neurological diseases

- Mental disorders

- Sleep apnea

- Long-term hemodialysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
machine bathing
machine bathing 20-min duration at evening
traditional bathing
traditional bathing

Locations

Country Name City State
Taiwan Taichung Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary sleep quality Polysomnography, PSG the night after intervention
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