Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722771
• Other study ID #: 106
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: November 2, 2018

Study information

• Verified date: June 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Sedative; Anxiety Disorder

Intervention

Behavioral:
• Inhalation
lavender oil inhalation in a separate room for 3 minutes prior to surgery

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

Diagnostic Test:
• Vital Signs 1
Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
• Vital Signs 2
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
• Vital Signs 3
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
• Vital Signs 4
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.

Locations

Country	Name	City	State
Turkey	Nazife Begüm KARAN	Ri?ze	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Nazife Begüm KARAN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital Sign Measurements - 1 - changes in blood pressure	changes in blood pressure	through study completion an average of 3 months
Primary	Vital Sign Measurements - 2 - changes in respiratory rate	changes in respiratory rate	through study completion an average of 3 months
Primary	Vital Sign Measurements - 3 - changes in heart rate	changes in heart rate	through study completion an average of 3 months
Primary	Vital Sign Measurements - 4 - changes in saturation level	changes in saturation level	through study completion an average of 3 months
Secondary	Anxiety Test 1 - MDAS tests	MDAS tests	through study completion an average of 3 months
Secondary	Anxiety Test 2 - STAI-S tests	STAI-S tests	through study completion an average of 3 months