SleepNCT03251274
Bath Machine on Sleep Quality in Nursing Home
A study testing machine bathing and traditional bathing in people with Sleep, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- machine bathing and traditional bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute illness
- Diabetes
- Peripheral blood vessels or neurological diseases
- Mental disorders
- Sleep apnea
- Long-term hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep
- Being tested
- machine bathing, traditional bathing
- Keywords
- bath machine, sleep quality, nursing home, heart rate variability
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
machine bathingOther
machine bathing 20-min duration at evening
traditional bathingOther
traditional bathing
| Study group | Role | What they receive |
|---|---|---|
| machine bathing group | Experimental | structured machine bathing for 20-min duration at evening. Receives: Other: machine bathing |
| traditional bathing group | Active comparator | traditional bathing at evening. Receives: Other: traditional bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
Polysomnography, PSG
Measured: the night after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start5 Sep 2017
- Primary completion5 Sep 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- machine bathing group traditional bathing group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-Liang Lai, Principal investigator, Taichung Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251274
- Sponsor's protocol ID
- CMUH105-REC3-138
- Status last verified
- Mar 2020
- First submitted
- 28 Jul 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: participant's data of polysomnography and heart rate variability can be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eddy Current Function of Bath Machine on Sleep Quality in Nursing Home
- ClinicalTrials.gov ID
- NCT03251274
- Acronym / sponsor ID
- CMUH105-REC3-138
- Conditions
- Sleep
- Keywords
- bath machine, sleep quality, nursing home, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- machine bathing group traditional bathing group
| Arm | Type | Receives |
|---|---|---|
| machine bathing group | Experimental | Other: machine bathingstructured machine bathing for 20-min duration at evening. |
| traditional bathing group | Active comparator | Other: traditional bathingtraditional bathing at evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Acute illness
- Diabetes
- Peripheral blood vessels or neurological diseases
- Mental disorders
- Sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| machine bathingmachine bathing 20-min duration at evening | Other | machine bathing group |
| traditional bathingtraditional bathing | Other | traditional bathing group |
Primary outcome
sleep quality
Time frame: the night after intervention
Polysomnography, PSG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided. participant's data of polysomnography and heart rate variability can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Liang Lai principal investigator
Taichung Hospital, Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing machine bathing and traditional bathing in people with Sleep, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: the night after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.