Kneipp Water Applications for Insomnia

Sleep Disturbance Clinical Trial

— KWAI  

Official title:

Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114189
• Other study ID #: 16-7003-BO
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2021
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Procedure:
• footbath

Behavioral:
• care of sleep

Locations

Country	Name	City	State
Germany	• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of sleep quality	Use Pittsburgh sleep quality index	T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization