Bath Machine on Sleep Quality in Nursing Home

The Effect of Eddy Current Function of Bath Machine on Sleep Quality in Nursing Home

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: machine bathing; Other: traditional bathing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40343
    • Taichung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: machine bathing group; structured machine bathing for 20-min duration at evening.	Other: machine bathing; machine bathing 20-min duration at evening
Active Comparator: traditional bathing group; traditional bathing at evening.	Other: traditional bathing; traditional bathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality	Polysomnography, PSG	the night after intervention

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Chung-Liang Lai, Taichung Hospital, Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): September 5, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: nursing home; sleep quality; heart rate variability; bath machine
• Other Study ID Numbers: CMUH105-REC3-138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: participant's data of polysomnography and heart rate variability can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No