NCT05728190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 4, 2023

Last Update Submit

February 4, 2023

Conditions

Aromatherapy

Keywords

burnAnxietylavender aromatherapynursingpainsleep quality

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Lavender essential oil

EXPERIMENTAL

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

Steril/Salin water

PLACEBO COMPARATOR

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

Interventions

steril/salin waterOTHER

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.

Steril/Salin water
Lavender essential oilOTHER

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.

Lavender essential oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-65,
  • nd 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Yenimahalle, Ankara, 06050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BurnsAnxiety DisordersPainSleep Initiation and Maintenance Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Wounds and InjuriesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • ayten akkaya, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

February 4, 2023

First Posted

February 15, 2023

Study Start

October 1, 2021

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)