A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The study sample will be divided randomly into 4 groups, each group will contain 27 children
      who need treatment in mandibular teeth and require anesthesia with inferior alveolar nerve
      block which is considered a painful procedure.

      In the aromatherapy group, 3 drops of lavender-Neroli will be applied to cotton balls, which
      will be placed in a box designed with 3D printing to be placed on the nasal mask that is
      similar to the one used when administering nitrous oxide, so that the child inhales the aroma
      of the essential oil through the nasal mask. The mask is applied 5 minutes before
      administering local anesthesia in order to allow the child to inhale the oil aroma prior to
      and during local anesthesia.

      In the music group, the music will be played from the recorder prior to local anesthesia and
      during it, music will be chosen by the child from the cartoon movies/tv shows they watch so
      that it is from his environment and familiar to them.

      In The third group, both music and aromatherapy will drive the anesthesia process.

      In The control groups, the child will put on the same nasal mask without an aromatherapy box
      to obtain a placebo effect and then receive the anesthesia.
    

Detailed description: 
      The sample of this study were children attending the department of pediatric dentistry
      faculty of dentistry, Damascus university, who need treatment in the mandibular teeth with an
      IANB injection After taking informed consent from the parent, the children were divided into
      4 groups: aromatherapy intervention, music intervention, both aroma, and music intervention,
      and control groups

      In the aromatherapy group:

      firstly the essential oils were obtained from Biocham Natural Extracts co, Damascus,
      Syria(100%pure lavender (L.angustifolia), 100% pure Neroli (C. aranium)) and the main
      components of the oils were determined by gas chromatography, which was found to be 47%
      linalool acetate in lavender oil, and 37% linalool 9% limonene in Neroli oil Then A 15%
      lavender-Neroli oil was prepared by blending 2.3 ml lavender oil with 0.9 ml Neroli oil and
      diluting with grape seed oil to 20 ml which was done in the department of pharmacognosy,
      Faculty of pharmacy Damascus university In the dental treatment, A child will be allowed to
      inhale the aromatic scent of the oil blend through a cylindrical box which is 3D printed and
      contains cavities inside it and perforated from its upper and lower surface. It will be
      applied to the circular hole of the mask which is similar to the one that uses when supplying
      nitrous oxide. so that this box allows for safer aromatherapy, as it can be removed in the
      event of any allergy symptoms appearing on the child and provide him oxygen through the mask.

      3 drops of 15%lavender-Neroli blend were poured on cotton balls and then put on the aroma
      box, the box then was placed on the mask which was applied to the child's nose, so that the
      child inhales the scent of the aromatic blend through the holes in the bottom of the box,
      which faces the child's nose.

      The children were asked to inhale the aromatic oils blend 5 minutes before intervention and
      during needle insertion when administrating IANB injection.

      In the music group:

      The child asks to choose a song from their cartoons and program to make it familiar to them
      and desirable and then listen to it through a recorder So that the music is heard as a
      background in the environment surrounding the work to avoid isolating the child from his
      environment and the ability to continue audio communication between the doctor and the child.

      The songs will play 5 minutes before and during needle administrating. In the combination
      group: aromatherapy and music were used above In the control group: the children who received
      IANB injection-s will be treated with child behavior management like tell-show-do and the
      nitrous oxide nasal mask was used without the box which was used to carry inside it the scent
      of the aromatic oils blend to obtain a placebo effect.

      The child's anxiety level would be assessed through FLACC, Facial image scale, heart rate,
      systolic, Diastolic blood pressure, and respiratory saturation before and after injection.

      The IANB injection was performed using a 27-gauge needle and a local anesthetic of 2%
      lidocaine with 1:100,000 epinephrine by one researcher.
    

Intervention name(s): Aromatherapy; Music; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Aroma therapy will apply before 5 minutes and during IANB injection in children, aromatherapy will apply through a nasal mask similar to one that uses when applying nitrous oxide after putting a 3d printed perforated box on the mask's circular halo on its surface, in this box cotton bolls impregnated with 3 drops of a 15% lavender-neroli oils blend are placed and then the child will smell the scent of aromatic oil blend from the box's perforated bottom surface which faces child's nose; Music will be played from a speaker in the treatment environment and will start 5 minutes before anesthesia and will be played through the whole anesthesia process, the music used will be chosen by the child from his favourite cartoon; using a tell-show-do approach and children will put on a nasal mask without the box that contains an aromatic oil blend for the placebo effect
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aromatherapy; music; lavender; neroli; anxiety