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Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

Primary Purpose

Dental Anxiety, Sedative; Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inhalation
Anxiety Questionnaires 1
Anxiety Questionnaires 2
Vital Signs 1
Vital Signs 2
Vital Signs 3
Vital Signs 4
Sponsored by
Nazife Begüm KARAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Anxiety focused on measuring Lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia

Eligibility Criteria

18 Years - 37 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nazife Begüm KARAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

lavender oil group (A)

control group (B)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Vital Sign Measurements - 1 - changes in blood pressure
changes in blood pressure
Vital Sign Measurements - 2 - changes in respiratory rate
changes in respiratory rate
Vital Sign Measurements - 3 - changes in heart rate
changes in heart rate
Vital Sign Measurements - 4 - changes in saturation level
changes in saturation level

Secondary Outcome Measures

Anxiety Test 1 - MDAS tests
MDAS tests
Anxiety Test 2 - STAI-S tests
STAI-S tests

Full Information

First Posted
October 22, 2018
Last Updated
June 9, 2020
Sponsor
Nazife Begüm KARAN
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1. Study Identification

Unique Protocol Identification Number
NCT03722771
Brief Title
Influence of Lavender Oil on Vital Signs in Oral Surgery Patients
Official Title
Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazife Begüm KARAN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Sedative; Anxiety Disorder
Keywords
Lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lavender oil group (A)
Arm Type
Experimental
Arm Description
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)
Arm Title
control group (B)
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Inhalation
Other Intervention Name(s)
lavender oil application
Intervention Description
lavender oil inhalation in a separate room for 3 minutes prior to surgery
Intervention Type
Other
Intervention Name(s)
Anxiety Questionnaires 1
Other Intervention Name(s)
Modified Dental Anxiety Scale
Intervention Description
Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
Intervention Type
Other
Intervention Name(s)
Anxiety Questionnaires 2
Other Intervention Name(s)
State-Trait Anxiety Inventory-State Scale
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vital Signs 1
Other Intervention Name(s)
Blood Pressure
Intervention Description
Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vital Signs 2
Other Intervention Name(s)
Respiratory rate
Intervention Description
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vital Signs 3
Other Intervention Name(s)
Heart rate
Intervention Description
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vital Signs 4
Other Intervention Name(s)
Saturation
Intervention Description
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Primary Outcome Measure Information:
Title
Vital Sign Measurements - 1 - changes in blood pressure
Description
changes in blood pressure
Time Frame
through study completion an average of 3 months
Title
Vital Sign Measurements - 2 - changes in respiratory rate
Description
changes in respiratory rate
Time Frame
through study completion an average of 3 months
Title
Vital Sign Measurements - 3 - changes in heart rate
Description
changes in heart rate
Time Frame
through study completion an average of 3 months
Title
Vital Sign Measurements - 4 - changes in saturation level
Description
changes in saturation level
Time Frame
through study completion an average of 3 months
Secondary Outcome Measure Information:
Title
Anxiety Test 1 - MDAS tests
Description
MDAS tests
Time Frame
through study completion an average of 3 months
Title
Anxiety Test 2 - STAI-S tests
Description
STAI-S tests
Time Frame
through study completion an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazife Begüm KARAN
Organizational Affiliation
Recep Tayyip Erdogan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nazife Begüm KARAN
City
Ri̇ze
State/Province
Merkez
ZIP/Postal Code
053100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31505191
Citation
Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
Results Reference
derived

Learn more about this trial

Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

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