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

Sleep Quality Clinical Trial

Official title:

The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort Among Ventilator-Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06380933
• Other study ID #: B11103008
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 28, 2024
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comfort
• Sleep Quality

Intervention

Other:
• 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

Locations

Country	Name	City	State
Taiwan	Hsu Mei-Lian	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Richards-Campbell Sleep Questionnaire	0-100mm	day 1 and implementation of interventions
Secondary	Numerical Rating of Comfort	0-10 points	day1and implementation of interventions