Clinical trial NCT05728190: Effect of Aromatherapy on Pain, Anxiety and Sleep Quality in Burn Patients
Official title: Effect of Inhalation Aromatherapy on Pain, Anxiety, and Sleep Quality in Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatherapy
Keywords: burn
Anxiety
lavender aromatherapy
nursing
pain
sleep quality
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study, which was designed as a randomized placebo-controlled experimental study, was conducted to determine the effect of inhalation aromatherapy with lavender essential oil on pain, anxiety and sleep quality in burn patients.

Detailed description: After 5 patients were included in the sample size of the study, intervention and control groups, power analysis was performed using the G\*Power Software (3.1.9.2) program. With a margin of error of 5%, an effect size of 0.15, and a power of 95%, the sample group size was calculated as 54 patients. Considering that data loss might be 10% on average in the study, it was decided to recruit 60 patients. Participants were randomized according to patient rooms. There are a total of 11 rooms and 16 beds in the burn unit, 5 double and 6 single. 11 rooms are numbered sequentially according to their location in the corridor.

In the intervention group, seven drops of lavender essential oil were dripped onto a 5x5 gauze pad in the morning and evening, for 20 minutes, 10 cm away from the nose, and sniffed.

In the placebo control group, seven drops of saline/sterile water were dripped onto a 5x5 gauze pad in the morning and evening, and they were put to sniff for 20 minutes, 10 cm away from the nose. Green food coloring was added (one drop of food coloring to 5 ml of sterile/saline water) to make sterile/saline water similar to lavender oil. Data were collected using Individual Data Collection Form, Spielberg State Anxiety Scale, Visual Analog Scale, Richard Campbell Sleep Scale before and after five days of morning and evening aromatherapy application.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65,
* 2nd and/or 3rd degree burns but not in emergency/resuscitative phase,
* Total body burn area is 5-30%,
* No acute-chronic respiratory system disease (asthma, COPD, etc.),
* No problem in sense of smell,
* No communication problem,
* Not participating in another study at the same time,
* Patients who volunteered to participate in the study.

Exclusion Criteria:

* Those who are allergic to lavender essential oil,
* Having a history of head trauma or convulsions,
* Having respiratory tract (inhalation) burn,
* Having alcohol or narcotic substance addiction,
* Having a history of pregnancy, epilepsy, high blood pressure and migraine,
* Patients undergoing intubation.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 5 days
measure: Spielberg State Anxiety Scale
timeFrame: 5 days
measure: Richard Campbell Sleep Scale
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Ankara Medipol University
state: Ankara
Study officials:
affiliation: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
name: ayten akkaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: