Sleep DisturbanceKWAINCT03114189
Kneipp Water Applications for Insomnia
A study testing footbath and care of sleep in people with Sleep Disturbance, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- footbath and care of sleep
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Nov 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age: 18 years
- Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)
Who cannot join
- secundary sleeping disease
- Mental diseases which require therapy
- Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin
- Severe comorbidity
- Gravidity
- Shift work
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- Voyages (>3 times during the study)
- regulary application of Kneipp
- Participation on other studies to therapy sleeping diseases or stress
Trial locations and contacts
1 site in 1 country.
Germany1 site
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen
About this study
Official title: Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric
The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.
- Conditions
- Sleep Disturbance
- Being tested
- footbath, care of sleep
- Keywords
- Sleep disturbance, footbath, Kneipp, care of sleep, sleep
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
footbathProcedure or surgery
care of sleepBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Footbath, care of sleep | Active comparator | Warm water (37°C) filled up to the level of the ankle. Water has to be heated up to 42°C and increased to the calf 's half height within 15 minutes.
Information about wrong and correct behaviour. Receives: Procedure: footbath; Behavioral: care of sleep |
| Care of sleep | Active comparator | Information about wrong and correct behaviour. Receives: Behavioral: care of sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sleep quality
Use Pittsburgh sleep quality index
Measured: T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startNov 2016
- Primary completionJul 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Klose, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114189
- Sponsor's protocol ID
- 16-7003-BO
- Acronym
- KWAI
- Status last verified
- Oct 2021
- First submitted
- 8 Nov 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric
- ClinicalTrials.gov ID
- NCT03114189
- Acronym / sponsor ID
- KWAI / 16-7003-BO
- Conditions
- Sleep Disturbance
- Keywords
- Sleep disturbance, footbath, Kneipp, care of sleep, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Apr 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 purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Footbath, care of sleep | Active comparator | Procedure: footbath, Behavioral: care of sleepWarm water (37°C) filled up to the level of the ankle. Water has to be heated up to 42°C and increased to the calf 's half height within 15 minutes. Information about wrong and correct behaviour. |
| Care of sleep | Active comparator | Behavioral: care of sleepInformation about wrong and correct behaviour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minimum age: 18 years
- Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)
Key exclusion criteria (9 listed)
- secundary sleeping disease
- Mental diseases which require therapy
- Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin
- Severe comorbidity
- Gravidity
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 |
|---|---|---|
| footbath | Procedure or surgery | Footbath, care of sleep |
| care of sleep | Behavioural | Care of sleep, Footbath, care of sleep |
Primary outcome
Change of sleep quality
Time frame: T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization
Use Pittsburgh sleep quality index
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 6 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing footbath and care of sleep in people with Sleep Disturbance, run by Universität Duisburg-Essen at 1 site in Germany.
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 2 inclusion and 9 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 6 Oct 2021. 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 Germany. 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?
Change of sleep quality (time frame: T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization). 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 6 Oct 2021.