Clinical trial NCT05377983: The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft
Official title: The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Keywords: lavender oil
pain
anxiety
sleep
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Up to five days
measure: Anxiety level
timeFrame: Up to five days
measure: Sleep quality
timeFrame: Up to five days
Secondary outcomes:
Other outcomes:
Locations:
city: Maltepe
country: Turkey
facility: Yesim Dikmen Aydin
state: İstanbul
Study officials:
affiliation: Marmara University Faculty of Health Sciences,
name: YEŞİM DİKMEN AYDIN
role: PRINCIPAL_INVESTIGATOR
References: