Clinical trial NCT04210895: Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep
Official title: Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonorganic Insomnia
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in global PSQI Score
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
Secondary outcomes:
measure: Change in subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in sleep latency as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in sleep duration as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in sleep efficiency as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in sleep disturbance as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in use of sleep medication as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in daytime dysfunction as assessed by the PSQI
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in the Insomnia Severity Index total score
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Evening protocol: Change in general well-being as assessed by a standardized sleep diary
timeFrame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Evening protocol: Change in the average performance as assessed by a standardized sleep diary
timeFrame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Evening protocol: Change in fatigue as assessed by a standardized sleep diary
timeFrame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Evening protocol: Change in sleep during daytime as assessed by a standardized sleep diary
timeFrame: In the evening (before going to sleep), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Morning protocol: Change in recovery ability as assessed by a standardized sleep diary
timeFrame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Morning protocol: Change in general well-being as assessed by a standardized sleep diary
timeFrame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Morning protocol: Change in sleep latency as assessed by a standardized sleep diary
timeFrame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Morning protocol: Change in nocturnal awakening as assessed by a standardized sleep diary
timeFrame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Morning protocol: Change in sleep duration as assessed by a standardized sleep diary
timeFrame: In the morning (after waking up), during the two-week intervention phase between pre intervention (baseline) and post intervention (2 weeks after baseline)
measure: Change in quality of life as assessed by the 12-Item Short Form Survey
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire
timeFrame: Baseline (pre intervention), 2 weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in RMSSD
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in SDNN
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in pNN50
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in VLF
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in LF
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in HF
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Heart rate variability analysis (HRV): Change in LF/HF ratio
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
measure: Change in distal-proximal skin-temperature gradient
timeFrame: Baseline (pre intervention) and two weeks after baseline (post intervention)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute
name: Jan Vagedes, MD
role: STUDY_DIRECTOR
References: