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A feasibility randomized-controlled cross-over trial of home-based warm footbath to improve sleep in the chronic phase of traumatic brain injury

A feasibility randomized-controlled cross-over trial of home-based warm footbath to improve sleep in the chronic phase of traumatic brain injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009072
Enrollment
Unknown
Registered
2016-08-24
Start date
2013-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disturbance after traumatic brain injury

Interventions

2:home-based warm footbath
Group A:Routine care after home-based warm footbath
Group B:Rouine care before home-based warm footbath

Sponsors

Ministry of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: To be included in this study, participants were aged between 20 and 65 years, have diagnosed with first-ever TBI over one year since head injury, were able to communicate in Chinese, had a complaint of insomnia after TBI with a Insomnia Severity Index (ISI) score > 10 (Morin, Belleville, Belanger, & Ivers, 2011), and are able to complete the entire process of home-based warm footbath.

Exclusion criteria

Exclusion criteria: Exclusion criteria included patients who were diagnosed with a psychiatric disease, sleep disturbances, substance abuse, uncontrolled cardiovascular disease, and peripheral neuropathy prior the diagnosis of TBI that might impede their participation in warm footbath. Participants were also ineligible if they were shift workers, pregnant, or suspected obstructive sleep apnea screened by Berlin questionnaire of two or more categories.

Design outcomes

Primary

MeasureTime frame
sleep efficiency;sleep onset latency;total sleep time;wake after sleep onset ;

Countries

China

Contacts

Public ContactPin-Yuan Chen

Chang Gung Memorial Hospital

pinyuanc@gmail.com+886 2 27361661-6329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026