NCT03722771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

October 22, 2018

Last Update Submit

June 9, 2020

Conditions

Dental AnxietySedative; Anxiety Disorder

Keywords

Lavandulaphytotherapyaromatherapydental anxietyanaesthesia

Outcome Measures

Primary Outcomes (4)

  • Vital Sign Measurements - 1 - changes in blood pressure

    changes in blood pressure

    through study completion an average of 3 months

  • Vital Sign Measurements - 2 - changes in respiratory rate

    changes in respiratory rate

    through study completion an average of 3 months

  • Vital Sign Measurements - 3 - changes in heart rate

    changes in heart rate

    through study completion an average of 3 months

  • Vital Sign Measurements - 4 - changes in saturation level

    changes in saturation level

    through study completion an average of 3 months

Secondary Outcomes (2)

  • Anxiety Test 1 - MDAS tests

    through study completion an average of 3 months

  • Anxiety Test 2 - STAI-S tests

    through study completion an average of 3 months

Study Arms (2)

lavender oil group (A)

EXPERIMENTAL

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: InhalationOther: Anxiety Questionnaires 1Other: Anxiety Questionnaires 2Diagnostic Test: Vital Signs 1Diagnostic Test: Vital Signs 2Diagnostic Test: Vital Signs 3Diagnostic Test: Vital Signs 4

control group (B)

SHAM COMPARATOR

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 1Other: Anxiety Questionnaires 2Diagnostic Test: Vital Signs 1Diagnostic Test: Vital Signs 2Diagnostic Test: Vital Signs 3Diagnostic Test: Vital Signs 4

Interventions

InhalationBEHAVIORAL

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

Also known as: lavender oil application
lavender oil group (A)
Anxiety Questionnaires 1OTHER

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

Also known as: Modified Dental Anxiety Scale
control group (B)lavender oil group (A)
Anxiety Questionnaires 2OTHER

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.

Also known as: State-Trait Anxiety Inventory-State Scale
control group (B)lavender oil group (A)
Vital Signs 1DIAGNOSTIC_TEST

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

Also known as: Blood Pressure
control group (B)lavender oil group (A)
Vital Signs 2DIAGNOSTIC_TEST

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

Also known as: Respiratory rate
control group (B)lavender oil group (A)
Vital Signs 3DIAGNOSTIC_TEST

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

Also known as: Heart rate
control group (B)lavender oil group (A)
Vital Signs 4DIAGNOSTIC_TEST

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

Also known as: Saturation
control group (B)lavender oil group (A)

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazife Begüm KARAN

Rize, Merkez, 053100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31505191DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

InhalationBlood PressureRespiratory RateHeart RateOxygen Saturation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaMetabolism

Study Officials

  • Nazife Begüm KARAN

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, DDS, PhD

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 29, 2018

Study Start

September 1, 2017

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)