Nursing CariesNCT05704946
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease
A study testing THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE in people with Nursing Caries, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The study is planned to be conducted as a two-group randomized controlled trial to determine the effect of lavender inhalation on individuals with coronary heart disease. Research data will be collected at Çukurova University Medical Faculty Balcalı Hospital Cardiology Clinic between January-June 2023. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Jul 2023
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and speak Turkish,
- Who agreed to participate in the research
Who cannot join
- People with communication difficulties and mental retardation
- People with coagulation disorders
- People with migraines and chronic headaches
- People with an allergy to lavender (Lavandula angustifolia Mill)
- It is the desire to leave the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University Institute of Health Sciences
Adana, 01030
About this study
Official title: The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease: a Randomized Controlled Study
The study is planned to be conducted as a two-group randomized controlled trial to determine the effect of lavender inhalation on individuals with coronary heart disease. Research data will be collected at Çukurova University Medical Faculty Balcalı Hospital Cardiology Clinic between January-June 2023. In the study, at least 56 samples were found to be sufficient for the sample size. The data of the study will be collected using the Personal Information Form and the Pittsburg Sleep Quality Index.
- Conditions
- Nursing Caries
- Being tested
- THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASEOther
The index includes 24 questions that evaluate the quality of sleep and the type and severity of sleep disorders experienced in the last 1 month period. The total score in the index takes a value between 0-21. If the total score is higher than 5, it is interpreted as poor sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | The patients will be given a standard brand of lavender oil by the researcher, and they will be informed about how to use it (they should drop 2 drops of lavender oil on the right side of their pillow and 2 drops on the left side of their pillow every evening for a month after discharge). Receives: Other: THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE |
| control group | No intervention | Standard care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of lavender inhalation on sleep quality
The index includes 24 questions that evaluate the quality of sleep and the type and severity of sleep disorders experienced in the last 1 month period. The total score in the index takes a value between 0-21. If the total score is higher than 5, it is interpreted as poor sleep quality.
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Mar 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Deniz Dogan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704946
- Sponsor's protocol ID
- 5312256930
- Status last verified
- Aug 2023
- First submitted
- 19 Jan 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05704946
- Acronym / sponsor ID
- 5312256930
- Conditions
- Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 30 Jan 2023 (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.
The study is planned to be conducted as a two-group randomized controlled trial to determine the effect of lavender inhalation on individuals with coronary heart disease. Research data will be collected at Çukurova University Medical Faculty Balcalı Hospital Cardiology Clinic between January-June 2023. In the study, at least 56 samples were found to be sufficient for the sample size. The data of the study will be collected using the Personal Information Form and the Pittsburg Sleep Quality Index.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASEThe patients will be given a standard brand of lavender oil by the researcher, and they will be informed about how to use it (they should drop 2 drops of lavender oil on the right side of their pillow and 2 drops on the left side of their pillow every evening for a month after discharge). |
| control group | No intervention | –Standard care will be applied. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to understand and speak Turkish,
- Who agreed to participate in the research
Key exclusion criteria (5 listed)
- People with communication difficulties and mental retardation
- People with coagulation disorders
- People with migraines and chronic headaches
- People with an allergy to lavender (Lavandula angustifolia Mill)
- It is the desire to leave the research.
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 |
|---|---|---|
| THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASEThe index includes 24 questions that evaluate the quality of sleep and the type and severity of sleep disorders experienced in the last 1 month period. The total score in the index takes a value between 0-21. If the total score is higher than 5, it is interpreted as poor sleep quality. | Other | experiment group |
Primary outcome
Effect of lavender inhalation on sleep quality
Time frame: one months
The index includes 24 questions that evaluate the quality of sleep and the type and severity of sleep disorders experienced in the last 1 month period. The total score in the index takes a value between 0-21. If the total score is higher than 5, it is interpreted as poor sleep quality.
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 8 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE in people with Nursing Caries, run by Cukurova University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 8 Aug 2023. 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 Turkey (Türkiye). 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?
Effect of lavender inhalation on sleep quality (time frame: one months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.