ClinicalTrials.gg
CompletedNCT06380933Updated Apr 24, 2024

The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort

An interventional study of experimental group in Sleep Quality and Comfort, sponsored by Dalin Tzu Chi General Hospital. Completed at 1 site in Taiwan. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Dalin Tzu Chi General Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2022, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath.

Read the detailed description

Methods: This study is a randomized clinical trial. It adopts a two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. The measurement tools used self-made structured questionnaires, the Richards-Campbell Sleep Questionnaire (RCSQ), Numerical Rating of Comfort (NRC), and heartbeat and blood pressure monitors. Data analysis included descriptive statistics, Chi-square and Fisher's exact correction tests, unpaired t tests and repeated measures ANOVA inferential statistical analysis.

02

Conditions studied

  • Sleep Quality
  • Comfort

Keywords

  • respirator-dependent patient
  • warm water foot baths
  • lavender essential oil
  • sleep quality
  • comfort level
  • heartbeat
  • blood pressure
03

In context

Sleep Initiation and Maintenance Disorders

1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.

This study's enrollment of 94 is above the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Dalin Tzu Chi General Hospital is the lead sponsor of 37 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have been using a ventilator for 21 days or more
  • Individuals aged 45 years or older
  • Clear consciousness and the ability to compare hands or hold a pen, with proficiency in Mandarin or Taiwanese communication
  • Willingness to participate in the study after receiving an explanation of the research purpose

Exclusion criteria

Exclusion Criteria:

  • Individuals with severe mental illness
  • Those with cognitive impairments
  • Severe visual or hearing impairments
  • History of lower limb venous thrombosis
  • Amputation or inflammation in the lower limbs
  • Muscle contractures in the lower limbs
  • Peripheral neuropathy
  • Allergic history related to essential oils
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    experimental group

    foot bath with lavender essential oil for 3 days, and then received routine care for 3 days

    Other: experimental group

  • No intervention
    control group

    first received routine care for 3 days, and then received lavender essential oil with foot bath for 3 days

Interventions

  • Otherexperimental group

    first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days

06

What researchers measure

Primary outcomes

  1. Richards-Campbell Sleep Questionnaire

    0-100mm

    Time frame: day 1 and implementation of interventions

Secondary outcomes

  1. Numerical Rating of Comfort

    0-10 points

    Time frame: day1and implementation of interventions

07

Study locations

1 site
  • Hsu Mei-Lian
    Chiayi City, Taiwan
08

References and documents

Publications

  • Aghamohammadi V, Salmani R, Ivanbagha R, Effati Daryani F, Nasiri K. Footbath as a safe, simple, and non-pharmacological method to improve sleep quality of menopausal women. Res Nurs Health. 2020 Dec;43(6):621-628. doi: 10.1002/nur.22082. Epub 2020 Oct 28. PubMed 33112004 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Sep 2022, 0 months.

Of 825 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 0 months is below that.

Counting every sponsor, half of 883 studies reached it within 19 months; a quarter within 7 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
Apr 24, 2024
StartActual
Sep 1, 2022
Primary completionActual
Sep 1, 2022
CompletionActual
Feb 28, 2024
Last update
Apr 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380933
Lead sponsor
Dalin Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
Sep 1, 2022
Primary completion
Sep 1, 2022
Completion
Feb 28, 2024
Last update
Apr 24, 2024

Study contacts

Hsu M L, BSN
principal investigator · Tzu Chi Medical Foundation Dalin Tzu Chi Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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