Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep

April 11, 2020 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep: a Randomized Controlled Pilot Study

A randomized, controlled trial to explore whether warm footbaths with added ginger powder can improve the sleep quality of adults with self-perceived insomnia symptoms. Participants receive daily footbaths either with warm water alone or with added ginger powder over a period of 2 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized controlled trial with parallel group design to explore the effects of warm water footbaths with added ginger powder (experimental) compared to footbaths with warm water alone (active comparator) on sleep quality in adults with self-perceived insomnia symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two weeks. The footbaths are prepared by the participants themselves and carried out at their homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after baseline (post intervention). The main focus is on change in subjective quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises analyses of variance based on linear mixed effects models.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • ARCIM Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent
  • age between 18 and 70 years
  • self-reported insomnia symptoms

Exclusion Criteria:

  • known organic insomnia (e.g. periodic leg movements during sleep, restless legs syndrome, sleep apnea syndrome, narcolepsy)
  • current intake of allopathic hypnotics
  • shift work
  • skin lesions at the lower legs or feet
  • known intolerance or hypersensitivity to ginger preparations
  • acute mental disorder
  • varicose vein (degree 3 or 4, classification according to Marshall), chronic venous insufficiency
  • pregnancy
  • participation in other studies
  • insufficient knowledge of the german language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Warm footbath with ginger powder
Participants receive a daily warm water footbath with added ginger powder over a two-week period
Other: Ginger powder footbath
40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level
ACTIVE_COMPARATOR: Warm water only footbath
Participants receive a daily warm water footbath over a two-week period
Other: Warm water only footbath
40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in global PSQI Score
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Global score of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 21=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep latency as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep duration as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep efficiency as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in sleep disturbance as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in use of sleep medication as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in daytime dysfunction as assessed by the PSQI
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scale of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 3=negative extreme
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in the Insomnia Severity Index total score
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Total score of the Insomnia Severity Index, score between 0=no clinically significant insomnia and 28=severe clinical insomnia
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Evening protocol: Change in general well-being as assessed by a standardized sleep diary
Time Frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported well-being measured with a standardized sleep diary (six-point rating scale, higher values represent a better outcome)
In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in the average performance as assessed by a standardized sleep diary
Time Frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported performance measured with a standardized sleep diary (six-point rating scale, lower values represent a better outcome)
In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in fatigue as assessed by a standardized sleep diary
Time Frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported fatigue measured with a standardized sleep diary (four-point rating scale, lower values represent a better outcome)
In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Evening protocol: Change in sleep during daytime as assessed by a standardized sleep diary
Time Frame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported sleep during daytime measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in recovery ability as assessed by a standardized sleep diary
Time Frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported recovery ability measured with a standardized sleep diary (five-point rating scale, lower values represent a better outcome)
In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in general well-being as assessed by a standardized sleep diary
Time Frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported well-being measured with a standardized sleep diary (six-point rating scale, higher values represent a better outcome)
In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep latency as assessed by a standardized sleep diary
Time Frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported sleep latency measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in nocturnal awakening as assessed by a standardized sleep diary
Time Frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported nocturnal awakening measured with a standardized sleep diary (specification in minutes, lower values represent a better outcome)
In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Morning protocol: Change in sleep duration as assessed by a standardized sleep diary
Time Frame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Self-reported sleep duration measured with a standardized sleep diary (specification in hours, higher values represent a better outcome)
In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
Change in quality of life as assessed by the 12-Item Short Form Survey
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Scales of the 12-Item Short Form Survey (SF-12), scores between 0=more dysfunction/impairment and 100=less dysfunction/impairment
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire
Time Frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Self-reported feeling of overall warmth and warmth at the face, trunk anterior/posterior, hands and feet measured with the Herdecke Warmth Perception Questionnaire, scores between 0=cold and 4=hot
Baseline (pre intervention), 2 weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in RMSSD
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Root mean square of successive differences (RMSSD) [ms]. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in SDNN
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Standard deviation of normal to normal (NN) intervals (SDNN) [ms]. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in pNN50
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
The proportion of NN50 (number of pairs of successive NNs that differ by more than 50 ms) divided by total number of NNs (pNN50). HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in VLF
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Very low frequency (VLF, 0.0033 to 0.04 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Low frequency (LF, 0.04 to 0.15 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in HF
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
High frequency (HF, 0.15 to 0.40 Hz) from frequency domain analysis. HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Heart rate variability analysis (HRV): Change in LF/HF ratio
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Ratio of two bands from frequency domain analysis: LF band (0.04 to 0.15 Hz) and HF band (0.15 to 0.40 Hz). HRV data are obtained from 24-hour ECG measurements with "Cardioscout Multi-ECG" (SR-Medizinelektronik, Stuttgart, Germany)
Baseline (pre intervention) and two weeks after baseline (post intervention)
Change in distal-proximal skin-temperature gradient
Time Frame: Baseline (pre intervention) and two weeks after baseline (post intervention)
24-hour measurement of the skin temperature at the feet and abdomen with "MAXIM I-Button™ DS1922L" (Maxim integrated, San Jose, USA). The gradient is calculated by subtracting the proximal value from the distal value.
Baseline (pre intervention) and two weeks after baseline (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.

IPD Sharing Time Frame

The data will be made available upon publication for a duration of three months.

IPD Sharing Access Criteria

The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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