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

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

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.

Study Overview

• Status: Completed
• Conditions: Aromatherapy
• Intervention / Treatment: Other: Lavender essential oil; Other: steril/salin water

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06050
      • Ankara Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Lavender essential oil; 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.
Placebo Comparator: 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.	Other: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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.	5 days
Spielberg State Anxiety Scale	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.	5 days
Richard Campbell Sleep Scale	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.	5 days

Collaborators and Investigators

• Sponsor: Sema Koçaşlı

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pain; Anxiety; nursing; sleep quality; burn; lavender aromatherapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1929/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No