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Kneipp Water Applications for Insomnia (KWAI)

Primary Purpose

Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
footbath
care of sleep
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring Sleep disturbance, footbath, Kneipp, care of sleep, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Footbath, care of sleep

Care of sleep

Arm Description

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.

Information about wrong and correct behaviour.

Outcomes

Primary Outcome Measures

Change of sleep quality
Use Pittsburgh sleep quality index

Secondary Outcome Measures

Full Information

First Posted
November 8, 2016
Last Updated
October 5, 2021
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT03114189
Brief Title
Kneipp Water Applications for Insomnia
Acronym
KWAI
Official Title
Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
Sleep disturbance, footbath, Kneipp, care of sleep, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Footbath, care of sleep
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Care of sleep
Arm Type
Active Comparator
Arm Description
Information about wrong and correct behaviour.
Intervention Type
Procedure
Intervention Name(s)
footbath
Intervention Type
Behavioral
Intervention Name(s)
care of sleep
Primary Outcome Measure Information:
Title
Change of sleep quality
Description
Use Pittsburgh sleep quality index
Time Frame
T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
City
Essen
Country
Germany

12. IPD Sharing Statement

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Kneipp Water Applications for Insomnia

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