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

Nonorganic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210895
• Other study ID #: INS_01
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: April 11, 2020

Study information

• Verified date: April 2020
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 11, 2020
• Est. primary completion date: April 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nonorganic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Ginger powder footbath
40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level
• Warm water only footbath
40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level

Locations

Country	Name	City	State
Germany	Arcim Institute	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)