Sleep QualityNCT06380933
The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort
A study testing experimental group in people with Sleep Quality and Comfort, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Comfort
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort Among Ventilator-Dependent Patients
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.
- Conditions
- Sleep Quality, Comfort
- Being tested
- experimental group
- Keywords
- respirator-dependent patient, warm water foot baths, lavender essential oil, sleep quality, comfort level, heartbeat, blood pressure
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | foot bath with lavender essential oil for 3 days, and then received routine care for 3 days Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richards-Campbell Sleep Questionnaire
0-100mm
Measured: day 1 and implementation of interventions
Secondary outcomes (1)
Numerical Rating of Comfort
0-10 points
Measured: day1and implementation of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Sep 2022
- Primary completion1 Sep 2022
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsu M L, BSN, Principal investigator, Tzu Chi Medical Foundation Dalin Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380933
- Sponsor's protocol ID
- B11103008
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort Among Ventilator-Dependent Patients
- ClinicalTrials.gov ID
- NCT06380933
- Acronym / sponsor ID
- B11103008
- Conditions
- Sleep Quality, Comfort
- Keywords
- respirator-dependent patient, warm water foot baths, lavender essential oil, sleep quality, comfort level, heartbeat, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: experimental groupfoot bath with lavender essential oil for 3 days, and then received routine care for 3 days |
| control group | No intervention | –first received routine care for 3 days, and then received lavender essential oil with foot bath for 3 days |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupfirst 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 | Other | experimental group |
Primary outcome
Richards-Campbell Sleep Questionnaire
Time frame: day 1 and implementation of interventions
0-100mm
1 secondary outcome
Numerical Rating of Comfort
Time frame: day1and implementation of interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 33112004Aghamohammadi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsu M L, BSN principal investigator
Tzu Chi Medical Foundation Dalin Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Sleep Quality and Comfort, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richards-Campbell Sleep Questionnaire (time frame: day 1 and implementation of interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.