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Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Primary Purpose

Dental Anxiety, Anxiety Disorder, Aromatherapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anxiety scale
Pain scale - 1
Pain scale - 2
Inhalation
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Anxiety focused on measuring lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nazife Begüm KARAN
  • Nazife Begüm KARAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lavender oil group

Control group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 2 (heart rate)
changes in heart rate pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 3 (saturation)
changes in saturation pre-operatively, intra-operatively, post-operatively

Secondary Outcome Measures

Anxiety Scale - Face Image Scale (FIS)
Five cartoon faces symbolized different emotions from very happy to very unhappy. The children chose one face at which they feel most like at that moment. One point is given to most positive face and 5 point is given to most negative face.
Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)
FLACC has five categories of behavior to rate pain as follows; facial expression, leg movement, activity, cry and consolability. The scores of each category are between 0 and 2. The total scores can change from 0 to 10 defined as mild (1-3), moderate (4-6) and severe (7-10).
Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)
WBS combines pictures and numbers to rate pain. The scale has six faces assigned numerical ratings from 0 'no hurt' to 10 'hurts worst'. Administration of WBS is easy, not time consuming and requires minimal instructions

Full Information

First Posted
October 2, 2019
Last Updated
October 4, 2019
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04115891
Brief Title
Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children
Official Title
Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Anxiety Disorder, Aromatherapy
Keywords
lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Double (Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender oil group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Anxiety scale
Intervention Description
Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.
Intervention Type
Other
Intervention Name(s)
Pain scale - 1
Intervention Description
Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction
Intervention Type
Other
Intervention Name(s)
Pain scale - 2
Intervention Description
Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction
Intervention Type
Behavioral
Intervention Name(s)
Inhalation
Other Intervention Name(s)
100 % pure, high strength lavender oil inhalation
Intervention Description
lavender oil inhalation in a separate room for 3 minutes prior to interventions
Primary Outcome Measure Information:
Title
Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
Description
changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively
Time Frame
through study completion an average of 9 months
Title
Vital Sign Measurements - 2 (heart rate)
Description
changes in heart rate pre-operatively, intra-operatively, post-operatively
Time Frame
through study completion an average of 9 months
Title
Vital Sign Measurements - 3 (saturation)
Description
changes in saturation pre-operatively, intra-operatively, post-operatively
Time Frame
through study completion an average of 9 months
Secondary Outcome Measure Information:
Title
Anxiety Scale - Face Image Scale (FIS)
Description
Five cartoon faces symbolized different emotions from very happy to very unhappy. The children chose one face at which they feel most like at that moment. One point is given to most positive face and 5 point is given to most negative face.
Time Frame
through study completion an average of 9 months
Title
Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)
Description
FLACC has five categories of behavior to rate pain as follows; facial expression, leg movement, activity, cry and consolability. The scores of each category are between 0 and 2. The total scores can change from 0 to 10 defined as mild (1-3), moderate (4-6) and severe (7-10).
Time Frame
through study completion an average of 9 months
Title
Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)
Description
WBS combines pictures and numbers to rate pain. The scale has six faces assigned numerical ratings from 0 'no hurt' to 10 'hurts worst'. Administration of WBS is easy, not time consuming and requires minimal instructions
Time Frame
through study completion an average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nazife Begüm KARAN
City
Ankara
State/Province
Merkez
ZIP/Postal Code
83TR2WATUF
Country
Turkey
Facility Name
Nazife Begüm KARAN
City
Ri̇ze
State/Province
Merkez
ZIP/Postal Code
053100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Beginning 3 months and ending 5 years following article publication all data will be shared with other researchers

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Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

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