Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115891
• Other study ID #: 07
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 30, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Aromatherapy
• Dental Anxiety

Intervention

Other:
• Anxiety scale
Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.
• Pain scale - 1
Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction
• 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

Locations

Country	Name	City	State
Turkey	Nazife Begüm KARAN	Ankara	Merkez
Turkey	Nazife Begüm KARAN	Ri?ze	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vital Sign Measurements - 2 (heart rate)	changes in heart rate pre-operatively, intra-operatively, post-operatively	through study completion an average of 9 months
Primary	Vital Sign Measurements - 3 (saturation)	changes in saturation pre-operatively, intra-operatively, post-operatively	through study completion an average of 9 months
Secondary	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
Secondary	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
Secondary	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