KWAI: Kneipp Water Applications for Insomnia

Sponsor

Universität Duisburg-Essen (Other)

Overall Status

Completed

CT.gov ID

NCT03114189

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Procedure: footbath Behavioral: care of sleep	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

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.	Procedure: footbath Behavioral: care of sleep
Active Comparator: Care of sleep Information about wrong and correct behaviour.	Behavioral: care of sleep

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.

Procedure: footbath

Behavioral: care of sleep

Active Comparator: Care of sleep

Information about wrong and correct behaviour.

Behavioral: care of sleep

Outcome Measures

Primary Outcome Measures

Change of sleep quality [T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization]
Use Pittsburgh sleep quality index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	• Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen		Germany

Sponsors and Collaborators

Universität Duisburg-Essen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Petra Klose, Director, Universität Duisburg-Essen

ClinicalTrials.gov Identifier:

NCT03114189

Other Study ID Numbers:

16-7003-BO

First Posted:

Apr 14, 2017

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Keywords provided by Petra Klose, Director, Universität Duisburg-Essen

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Oct 6, 2021