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

NCT ID: NCT05728190

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-04-15

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.

Conditions

Aromatherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lavender essential oil

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

steril/salin water

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sema Koçaşlı

OTHER

Sponsor Role: lead

Responsible Party

Sema Koçaşlı

Assist. Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ayten akkaya, PhD

Role: PRINCIPAL_INVESTIGATOR

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing

Locations

Ankara Medipol University

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1929/2021

Identifier Type: -

Identifier Source: org_study_id