Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Overview

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.

Full Title of Study: “Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2019

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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)
  • 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)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Anxiety Scale – Face Image Scale (FIS)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Recep Tayyip Erdogan University Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nazife Begüm KARAN, Assistant Professor, DDS, PhD – Recep Tayyip Erdogan University Training and Research Hospital

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