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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nonorganic Insomnia

Intervention / Treatment
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* Other: Ginger powder footbath
* Other: Warm water only footbath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm footbath with ginger powder<br>Participants receive a daily warm water footbath with added ginger powder over a two-week period | Other: Ginger powder footbath<br>* 40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level<br>|
| Active Comparator: Warm water only footbath<br>Participants receive a daily warm water footbath over a two-week period | Other: Warm water only footbath<br>* 40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level<br>|

What is the study measuring?
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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) |