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The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease

Primary Purpose

Nursing Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Caries

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Çukurova University Institute of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experiment group

control group

Arm Description

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).

Standard care will be applied.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
August 7, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05704946
Brief Title
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease
Official Title
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experiment group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
Standard care will be applied.
Intervention Type
Other
Intervention Name(s)
THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of lavender inhalation on sleep quality
Description
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.
Time Frame
one months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Çukurova University Institute of Health Sciences
City
Adana
ZIP/Postal Code
01030
Country
Turkey

12. IPD Sharing Statement

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The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease

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