The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377983
• Other study ID #: MU-YDIKMEN-001
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: August 24, 2023

Study information

• Verified date: May 2022
• Source: Marmara University
• Contact: YESIM DIKMEN AYDIN
• Phone: +905426238394
• Email: yesimdikmen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Common pain, sleep problems, and anxiety after CABG surgery can cause delay in postoperative recovery both physically and mentally. The study was planned to evaluate the effect of lavender oil inhalation on pain, anxiety level and sleep quality after CABG surgery.

Description:

The study is a non-drug clinical, randomized controlled study, and will be conducted in the Cardiovascular Surgery Clinic of Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi associated to Istanbul Provincial Directorate of Health between December 2020 and December 2021. Criteria to be included in the study were determined as patients who are aged 18 years and over, underwent planned (elective) CABG surgery, whose lavender oil allergy test is negative, who is conscious with place, person and time orientation, who do not have any disability that would make communication difficult, can be communicated in Turkish, were informed to participate in the study and gave written consent. Criteria to be excluded from the study were determined as patients who are allergic to lavender, cosmetics and perfume, have a history of dermatitis, are diagnosed with sleep disorders and use any pharmacological and herbal medicines for these disorders, have sinusitis, upper respiratory tract infection, liver and kidney dysfunction, asthma and Chronic Obstructive Pulmonary Disease (COPD), whose blood pressure is not regulated, have arrhythmia, use controlled analgesia after surgery and cannot be communicated in Turkish. Criteria to be eliminated from the study were determined as patients, who have positive lavender oil allergy test, develop lavender allergy during application, want to leave the study voluntarily, and do not comply with the working process and conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 24, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria for the study were determined as follows:
• 18 years of age or older,
• undergoing elective CABG surgery,
• negative lavender oil allergy test,
• being conscious and oriented to place, person, and time,
• not having any disability that would make communication difficult,
• being able to communicate in Turkish, and
• giving informed written consent to participate in the study.

Exclusion Criteria:

• The exclusion criteria for the study were determined as follows:
• diagnosed with a sleep disorder or using any pharmacological and/or herbal medicine for insomnia,
• being allergic to lavender, cosmetics, or perfume,
• having a history of dermatitis,
• sinusitis,
• upper respiratory tract infection,
• liver and kidney dysfunction,
• asthma, and
• chronic obstructive pulmonary disease,
• not having regulated blood pressure,
• having arrhythmia,
• using patient-controlled analgesia after surgery,
• not being able to communicate in Turkish.
• The remaining exclusion criteria were determined as follows:
• a positive lavender oil allergy test,
• development of lavender allergy during the study,
• voluntarily deciding to leave the study, and
• not complying with the study process and conditions.

Related Conditions & MeSH terms

• Anxiety Disorders
• Coronary Artery Bypass Graft Surgery
• Respiratory Aspiration

Intervention

Other:
• Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes
During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day.

Locations

Country	Name	City	State
Turkey	Yesim Dikmen Aydin	Maltepe	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity, will be evaluated by NRS 3 times a day in the intervention and control group upon admission from the intensive care unit to the clinic, before and 30 minutes and four hours after each analgesic administration.In addition to this application, pain intensity will be evaluated with NRS before and five minutes after lavender oil inhalation in intervention group patients.	Up to five days
Primary	Anxiety level	Anxitey level will be evaluated using the STAI-I at four hours after analgesic administration in the intervention group and at five minutes after lavender oil inhalation.	Up to five days
Primary	Sleep quality	Sleep quality will also be evaluated using RCSQ every morning during.	Up to five days