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

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: Completed
• Conditions: Nonorganic Insomnia
• Intervention / Treatment: Other: Ginger powder footbath; Other: Warm water only footbath

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: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in global PSQI Score	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

Outcome Measure	Measure Description	Time Frame
Change in subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ACTUAL): April 11, 2020
• Study Completion (ACTUAL): April 11, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID 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