- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114189
Kneipp Water Applications for Insomnia (KWAI)
October 5, 2021 updated by: Petra Klose, Universität Duisburg-Essen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Essen, Germany
- • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Minimum age: 18 years
- Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)
Exclusion Criteria:
- secundary sleeping disease
- Mental diseases which require therapy
- Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin
- Severe comorbidity
- Gravidity
- Shift work
- Voyages (>3 times during the study)
- regulary application of Kneipp
- Participation on other studies to therapy sleeping diseases or stress
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Footbath, care of sleep
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. |
|
Active Comparator: Care of sleep
Information about wrong and correct behaviour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
April 10, 2017
First Posted (Actual)
April 14, 2017
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-7003-BO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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