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CompletedNCT03114189KWAIUpdated Oct 6, 2021

Kneipp Water Applications for Insomnia

An interventional study of footbath and care of sleep in Sleep Disturbance, sponsored by Universität Duisburg-Essen. Completed at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Sleep Disturbance

Keywords

  • Sleep disturbance
  • footbath
  • Kneipp
  • care of sleep
  • sleep
03

In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 251 interventional studies indexed under Dyssomnias.

Browse Dyssomnias studies →

Lead sponsor

Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

Interventions

  • Procedurefootbath
  • Behavioralcare of sleep
06

What researchers measure

Primary outcomes

  1. Change of sleep quality

    Use Pittsburgh sleep quality index

    Time frame: T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization

07

Study locations

1 site
  • • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
    Essen, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03114189
Lead sponsor
Universität Duisburg-Essen
Responsible party
Petra Klose (Director, Universität Duisburg-Essen) — Principal investigator
First posted
Apr 14, 2017
Start date
Nov 2016
Primary completion
Jul 2018
Completion
Nov 2018
Last update
Oct 6, 2021
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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