Clinical trial NCT06380933: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort
Official title: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort Among Ventilator-Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Comfort
Keywords: respirator-dependent patient
warm water foot baths
lavender essential oil
sleep quality
comfort level
heartbeat
blood pressure
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 94
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Richards-Campbell Sleep Questionnaire
timeFrame: day 1 and implementation of interventions
Secondary outcomes:
measure: Numerical Rating of Comfort
timeFrame: day1and implementation of interventions
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Hsu Mei-Lian
Study officials:
affiliation: Tzu Chi Medical Foundation Dalin Tzu Chi Hospital
name: Hsu M L, BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.