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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level
40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level
Arcim Institute
Filderstadt, Baden-Wurttemberg, Germany
Change in global PSQI Score
Global score of the Pittsburgh Sleep Quality Index, score between 0=positive extreme and 21=negative extreme
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
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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
Time frame: 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
Time frame: 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
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Baseline (pre intervention) and two weeks after baseline (post intervention)