Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

NCT ID: NCT03722771

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-11-02

Brief Summary

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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

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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.

Conditions

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Dental Anxiety Sedative; Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Inhalation

Intervention Type BEHAVIORAL

lavender oil inhalation in a separate room for 3 minutes prior to surgery

Anxiety Questionnaires 1

Intervention Type OTHER

Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.

Anxiety Questionnaires 2

Intervention Type OTHER

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.

Vital Signs 1

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.

Vital Signs 2

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.

Vital Signs 3

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.

Vital Signs 4

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 4 - saturation - before, during and after the procedure were noted.

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)

Group Type SHAM_COMPARATOR

Anxiety Questionnaires 1

Intervention Type OTHER

Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.

Anxiety Questionnaires 2

Intervention Type OTHER

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.

Vital Signs 1

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.

Vital Signs 2

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.

Vital Signs 3

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.

Vital Signs 4

Intervention Type DIAGNOSTIC_TEST

Changes in vital signs 4 - saturation - before, during and after the procedure were noted.

Interventions

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Inhalation

lavender oil inhalation in a separate room for 3 minutes prior to surgery

Intervention Type BEHAVIORAL

Anxiety Questionnaires 1

Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.

Intervention Type 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.

Intervention Type OTHER

Vital Signs 1

Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.

Intervention Type DIAGNOSTIC_TEST

Vital Signs 2

Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.

Intervention Type DIAGNOSTIC_TEST

Vital Signs 3

Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.

Intervention Type DIAGNOSTIC_TEST

Vital Signs 4

Changes in vital signs 4 - saturation - before, during and after the procedure were noted.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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lavender oil application Modified Dental Anxiety Scale State-Trait Anxiety Inventory-State Scale Blood Pressure Respiratory rate Heart rate Saturation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nazife Begüm KARAN

OTHER

Sponsor Role lead

Responsible Party

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Nazife Begüm KARAN

Assistant Professor, DDS, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nazife Begüm KARAN

Role: PRINCIPAL_INVESTIGATOR

Recep Tayyip Erdogan University

Locations

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Nazife Begüm KARAN

Rize, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 31505191 (View on PubMed)

Other Identifiers

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106

Identifier Type: -

Identifier Source: org_study_id

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