NCT03251274

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

July 28, 2017

Last Update Submit

March 5, 2020

Conditions

Sleep

Keywords

bath machinesleep qualitynursing homeheart rate variability

Outcome Measures

Primary Outcomes (1)

  • sleep quality

    Polysomnography, PSG

    the night after intervention

Study Arms (2)

machine bathing group

EXPERIMENTAL

structured machine bathing for 20-min duration at evening.

Other: machine bathing

traditional bathing group

ACTIVE COMPARATOR

traditional bathing at evening.

Other: traditional bathing

Interventions

machine bathingOTHER

machine bathing 20-min duration at evening

machine bathing group
traditional bathingOTHER

traditional bathing

traditional bathing group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than half a year in the institution
  • years of age (including) or above, with the help of bathing
  • Be conscious, able to listen, speak Chinese

You may not qualify if:

  • Acute illness
  • Diabetes
  • Peripheral blood vessels or neurological diseases
  • Mental disorders
  • Sleep apnea
  • Long-term hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Hospital

Taichung, 40343, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Chung-Liang Lai

    Taichung Hospital, Ministry of Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: machine bathing group traditional bathing group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 16, 2017

Study Start

September 5, 2017

Primary Completion

September 5, 2017

Study Completion

December 31, 2018

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

TW(1)