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

NCT ID: NCT05377983

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2023-08-24

Brief 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.

Detailed 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.

Conditions

Coronary Artery Bypass Graft Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

the intervention group

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. Pain intensity and vital signs will be evaluated and recorded before each application and in the first five minutes after the application.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day.

the control group

The control group will only receive routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YEŞİM DİKMEN AYDIN

Role: PRINCIPAL_INVESTIGATOR

Marmara University Faculty of Health Sciences,

Locations

Yesim Dikmen Aydin

Maltepe, Istanbul, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

YEŞIM DIKMEN AYDIN

Role: CONTACT

yesimdikmen@hotmail.com

+905426238394

Facility Contacts

YESIM DIKMEN AYDIN

Role: primary

yesimdikmen@hotmail.com

05426238394

Other Identifiers

MU-YDIKMEN-001

Identifier Type: -

Identifier Source: org_study_id