- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704946
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease
August 7, 2023 updated by: Sevgi Deniz Dogan, Cukurova University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Adana, Turkey, 01030
- Çukurova University Institute of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able to understand and speak Turkish,
- Who agreed to participate in the research
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experiment group
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).
|
Other: THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
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.
|
|
No Intervention: control group
Standard care will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
January 27, 2023
First Posted (Actual)
January 30, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5312256930
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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