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

Aromatherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05728190
• Other study ID #: 1929/2021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: February 2023
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Aromatherapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Medipol University	Yenimahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Sema Koçasli

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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