Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

June 9, 2020 updated by: Nazife Begüm KARAN

Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial

The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Ri̇ze, Merkez, Turkey, 053100
        • Nazife Begüm Karan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of wisdom tooth
  • Must be similar in age-height-weight
  • Must be similar socio-culturally

Exclusion Criteria:

  • Under 18 years of age
  • Taking psychotropic medication or psychiatric treatment
  • Systemically unhealthy patients
  • Pregnants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lavender oil group (A)

100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to surgery.

Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation)
Behavioral: Inhalation
lavender oil inhalation in a separate room for 3 minutes prior to surgery
Other Names:
  • lavender oil application
Other: Anxiety Questionnaires 1
Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
Other Names:
  • Modified Dental Anxiety Scale
Other: Anxiety Questionnaires 2
State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.
Other Names:
  • State-Trait Anxiety Inventory-State Scale
Diagnostic test: Vital Signs 1
Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
Other Names:
  • Blood Pressure
Diagnostic test: Vital Signs 2
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Other Names:
  • Respiratory rate
Diagnostic test: Vital Signs 3
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Other Names:
  • Heart rate
Diagnostic test: Vital Signs 4
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Other Names:
  • Saturation
Sham Comparator: control group (B)
No application of lavender oil, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation)
Other: Anxiety Questionnaires 1
Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
Other Names:
  • Modified Dental Anxiety Scale
Other: Anxiety Questionnaires 2
State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.
Other Names:
  • State-Trait Anxiety Inventory-State Scale
Diagnostic test: Vital Signs 1
Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
Other Names:
  • Blood Pressure
Diagnostic test: Vital Signs 2
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Other Names:
  • Respiratory rate
Diagnostic test: Vital Signs 3
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Other Names:
  • Heart rate
Diagnostic test: Vital Signs 4
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Other Names:
  • Saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Sign Measurements - 1 - changes in blood pressure
Time Frame: through study completion an average of 3 months
changes in blood pressure
through study completion an average of 3 months
Vital Sign Measurements - 2 - changes in respiratory rate
Time Frame: through study completion an average of 3 months
changes in respiratory rate
through study completion an average of 3 months
Vital Sign Measurements - 3 - changes in heart rate
Time Frame: through study completion an average of 3 months
changes in heart rate
through study completion an average of 3 months
Vital Sign Measurements - 4 - changes in saturation level
Time Frame: through study completion an average of 3 months
changes in saturation level
through study completion an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Test 1 - MDAS tests
Time Frame: through study completion an average of 3 months
MDAS tests
through study completion an average of 3 months
Anxiety Test 2 - STAI-S tests
Time Frame: through study completion an average of 3 months
STAI-S tests
through study completion an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazife Begüm KARAN

Investigators

  • Principal Investigator: Nazife Begüm KARAN, Recep Tayyip Erdoğan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

November 2, 2018

Study Completion (Actual)

November 2, 2018

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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