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

NCT06380933 | Completed

• 1 other identifier: B11103008
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; Comfort

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Richards-Campbell Sleep Questionnaire

  0-100mm

  day 1 and implementation of interventions

Secondary Outcomes (1)

• Numerical Rating of Comfort

  day1and implementation of interventions

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: experimental group

control group

NO INTERVENTION

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

Interventions

experimental group OTHER

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

experimental group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Hsu Mei-Lian

Chiayi City, Taiwan

Location

Related 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.

  PMID: 33112004 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hsu M L, BSN

  Tzu Chi Medical Foundation Dalin Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 24, 2024
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: February 28, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)