Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

NCT ID: NCT04115891

Last Updated: 2019-10-08

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

2019-01-01

Study Completion Date

2019-09-30

Brief Summary

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The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

Detailed Description

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Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.

Conditions

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Dental Anxiety Anxiety Disorder Aromatherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Double (Investigator, Outcomes Assessor)

Study Groups

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Lavender oil group

100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.

Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)

Group Type EXPERIMENTAL

Anxiety scale

Intervention Type OTHER

Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.

Pain scale - 1

Intervention Type OTHER

Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction

Pain scale - 2

Intervention Type OTHER

Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

Inhalation

Intervention Type BEHAVIORAL

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

Control group

No application prior to interventions. No lavender oil inhalation.

Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)

Group Type SHAM_COMPARATOR

Anxiety scale

Intervention Type OTHER

Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.

Pain scale - 1

Intervention Type OTHER

Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction

Pain scale - 2

Intervention Type OTHER

Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

Interventions

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Anxiety scale

Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.

Intervention Type OTHER

Pain scale - 1

Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction

Intervention Type OTHER

Pain scale - 2

Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

Intervention Type OTHER

Inhalation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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100 % pure, high strength lavender oil inhalation

Eligibility Criteria

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Inclusion Criteria

* being between 6 and 12 years of age
* children who are determined as Frankl 2, 3 or 4
* intellectually sufficient to complete the anxiety scale
* volunteer to take part in the study
* whose parents were willing to participate into the study

Exclusion Criteria

* aged under 6
* has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
* common allergies or dental pain
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nazife Begüm KARAN

Assistant Professor, DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nazife Begüm KARAN

Ankara, Merkez, Turkey (Türkiye)

Site Status

Nazife Begüm KARAN

Rize, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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07

Identifier Type: -

Identifier Source: org_study_id

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