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Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722771
Recruitment Status : Completed
First Posted : October 29, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Sedative; Anxiety Disorder Behavioral: Inhalation Other: Anxiety Questionnaires 1 Other: Anxiety Questionnaires 2 Diagnostic Test: Vital Signs 1 Diagnostic Test: Vital Signs 2 Diagnostic Test: Vital Signs 3 Diagnostic Test: Vital Signs 4 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Vital Signs

Arms and Interventions
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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 Name: lavender oil application

Other: Anxiety Questionnaires 1
Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
Other Name: 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 Name: 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 Name: Blood Pressure

Diagnostic Test: Vital Signs 2
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Other Name: Respiratory rate

Diagnostic Test: Vital Signs 3
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Other Name: Heart rate

Diagnostic Test: Vital Signs 4
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Other Name: 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 Name: 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 Name: 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 Name: Blood Pressure

Diagnostic Test: Vital Signs 2
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Other Name: Respiratory rate

Diagnostic Test: Vital Signs 3
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Other Name: Heart rate

Diagnostic Test: Vital Signs 4
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
Other Name: Saturation


Outcome Measures
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Primary Outcome Measures :
  1. Vital Sign Measurements - 1 - changes in blood pressure [ Time Frame: through study completion an average of 3 months ]
    changes in blood pressure

  2. Vital Sign Measurements - 2 - changes in respiratory rate [ Time Frame: through study completion an average of 3 months ]
    changes in respiratory rate

  3. Vital Sign Measurements - 3 - changes in heart rate [ Time Frame: through study completion an average of 3 months ]
    changes in heart rate

  4. Vital Sign Measurements - 4 - changes in saturation level [ Time Frame: through study completion an average of 3 months ]
    changes in saturation level


Secondary Outcome Measures :
  1. Anxiety Test 1 - MDAS tests [ Time Frame: through study completion an average of 3 months ]
    MDAS tests

  2. Anxiety Test 2 - STAI-S tests [ Time Frame: through study completion an average of 3 months ]
    STAI-S tests


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722771


Locations
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Turkey
Nazife Begüm KARAN
Ri̇ze, Merkez, Turkey, 053100
Sponsors and Collaborators
Nazife Begüm KARAN
Investigators
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Principal Investigator: Nazife Begüm KARAN Recep Tayyip Erdogan University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nazife Begüm KARAN, Assistant Professor, DDS, PhD, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03722771    
Other Study ID Numbers: 106
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital:
Lavandula
phytotherapy
aromatherapy
dental anxiety
anaesthesia
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders