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Completed

NCT Number: NCT04115891

Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

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.

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Key information

Conditions

Dental Anxiety Anxiety Disorder Anxiety Disorders Aromatherapy Mental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nazife Begüm KARAN, Ankara, Merkez, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety scale

Other

Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.

Pain scale - 1

Other

Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction

Pain scale - 2

Other

Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

Inhalation

Behavioral

lavender oil inhalation in a separate room for 3 minutes prior to interventions

Other names: 100 % pure, high strength lavender oil inhalation

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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.

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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