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

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

Conditions: Nonorganic Insomnia

Treatments: Other: Warm water only footbath; Other: Ginger powder footbath

Study type: Interventional

Funder types: Other

Identifiers

NCT04210895

INS_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Warm footbath with ginger powder

Experimental group

Description:

Participants receive a daily warm water footbath with added ginger powder over a two-week period

Treatment:

Other: Ginger powder footbath

Warm water only footbath

Active Comparator group

Description:

Participants receive a daily warm water footbath over a two-week period

Treatment:

Other: Warm water only footbath