Effect of Aromatherapy on Pain, Anxiety and Sleep Quality in Burn Patients

Not Applicable

Completed

• Conditions: Aromatherapy
• Interventions: Other: Lavender essential oil; Other: steril/salin water

• Registration Number: NCT05728190
• Lead Sponsor: Sema Koçaşlı

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-04
• Last Update Submitted: 2023-02-04
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavender essential oil	Lavender essential oil	In the intervention group, five days, 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.
Steril/Salin water	steril/salin water	Five days 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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	5 days	Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.; The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.; In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Spielberg State Anxiety Scale	5 days	The scale has a four-point Likert structure consisting of 20 items and a total score of 20-80 is obtained.; A score of 20 or less indicates that the individual does not have anxiety, a score between 21-39 indicates mild anxiety, a score between 40-59 indicates moderate, and a score between 60-80 indicates a high level of anxiety.
Richard Campbell Sleep Scale	5 days	There are 6 items in the scale. There are 5 items in the assessment. Each item is evaluated on the scale between 0 and 100. If the score is between "0-25", it indicates very bad sleep, and between "76-100" indicates very good sleep.

Trial Locations

Locations (1)

Ankara Medipol University; 🇹🇷 Yenimahalle, Ankara, Turkey