Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Not Applicable

Completed

• Conditions: Aromatherapy; Dental Anxiety; Anxiety Disorder
• Interventions: Other: Anxiety scale; Other: Pain scale - 1; Other: Pain scale - 2; Behavioral: Inhalation

• Registration Number: NCT04115891
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavender oil group	Anxiety scale	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)
Lavender oil group	Pain scale - 1	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)
Lavender oil group	Pain scale - 2	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)
Lavender oil group	Inhalation	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)
Control group	Anxiety scale	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)
Control group	Pain scale - 2	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)
Control group	Pain scale - 1	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Anxiety Scale - Face Image Scale (FIS)	through study completion an average of 9 months	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)	through study completion an average of 9 months	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)	through study completion an average of 9 months	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

Trial Locations

Locations (1)

Nazife Begüm KARAN; 🇹🇷 Ri̇ze, Merkez, Turkey