NCT03114189

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

November 8, 2016

Last Update Submit

October 5, 2021

Conditions

Sleep Disturbance

Keywords

Sleep disturbancefootbathKneippcare of sleepsleep

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Footbath, care of sleep

ACTIVE COMPARATOR

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: footbathBehavioral: care of sleep

Care of sleep

ACTIVE COMPARATOR

Information about wrong and correct behaviour.

Behavioral: care of sleep

Interventions

footbathPROCEDURE
Footbath, care of sleep
care of sleepBEHAVIORAL
Care of sleepFootbath, care of sleep

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum age: 18 years
  • Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Essen, Germany

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 8, 2016

First Posted

April 14, 2017

Study Start

November 1, 2016

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

DE(1)