NCT05704946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

28 days

First QC Date

January 19, 2023

Last Update Submit

August 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    one months

Study Arms (2)

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).

Other: THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE

control group

NO INTERVENTION

Standard care will be applied.

Interventions

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.

experiment group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and speak Turkish,
  • Who agreed to participate in the research

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Institute of Health Sciences

Adana, 01030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

February 1, 2023

Primary Completion

March 1, 2023

Study Completion

July 1, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations