Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Anxiety Disorder; Aromatherapy
• Intervention / Treatment: Other: Anxiety scale; Other: Pain scale - 1; Other: Pain scale - 2; Behavioral: Inhalation

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Ankara, Merkez, Turkey, 83TR2WATUF
      • Nazife Begüm Karan
    • Ri̇ze, Merkez, Turkey, 053100
      • Nazife Begüm Karan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Anxiety scale; Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.; Other: Pain scale - 1; Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction; Other: Pain scale - 2; Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction; Behavioral: Inhalation; lavender oil inhalation in a separate room for 3 minutes prior to interventions; Other Names: 100 % pure, high strength lavender oil inhalation
Sham Comparator: 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)	Other: Anxiety scale; Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.; Other: Pain scale - 1; Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction; Other: Pain scale - 2; Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)	changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively	through study completion an average of 9 months
Vital Sign Measurements - 2 (heart rate)	changes in heart rate pre-operatively, intra-operatively, post-operatively	through study completion an average of 9 months
Vital Sign Measurements - 3 (saturation)	changes in saturation pre-operatively, intra-operatively, post-operatively	through study completion an average of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion an average of 9 months
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).	through study completion an average of 9 months
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	through study completion an average of 9 months

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: phytotherapy; aromatherapy; dental anxiety; anaesthesia; lavandula
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Beginning 3 months and ending 5 years following article publication all data will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No