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

NCT ID: NCT04210895

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2020-04-11

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.

Conditions

Nonorganic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Warm footbath with ginger powder

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

Group Type: EXPERIMENTAL

Ginger powder footbath

Intervention Type: OTHER

40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level

Warm water only footbath

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

Group Type: ACTIVE_COMPARATOR

Warm water only footbath

Intervention Type: OTHER

40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level

Interventions

Ginger powder footbath

40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level

Intervention Type: OTHER

Warm water only footbath

40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, MD

Role: STUDY_DIRECTOR

ARCIM Institute

Locations

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

INS_01

Identifier Type: -

Identifier Source: org_study_id