Anxiolytic Effects of Lavender and Orange Oil

Anxiolytic Effects of Lavender and Orange Oil on Parents of Pediatric Patients With Dental Treatment Under Sedation

The aim of this study is to determine the possible anxiety reducing effects of lavender oil and orange oil on parents with children receiving dental care under sedation during perioperative wait.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Pediatric ALL; Anesthesia; Anxiety State; Oil; Inhalation
• Intervention / Treatment: Behavioral: Lavender/Orange

Detailed Description

Anxiety is a common problem for parents with children under sedation. It has long been known that operations, unconsciousness, the risks of the anesthesia and airway problems can cause a considerable amount of anxiety. Anxiety is associated with an uncertain psychological distress , and may vary to minor disturbances to extreme stress. The study aims to help parents improve their satisfaction by reducing their anxiety levels and ensure they have a better experience. In addition, anxiety can also prevent active participation of the parents during postoperative recovery. The physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. Lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. The lavender plant belongs to the Labitae family and has been used for centuries in dried or essential oil form. Lavender is obtained from flower heads and leaves with vapor distillation. This oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various interventions. Orange oil is an essential oil produced by cells within the rind of an orange fruit (Citrus sinensis fruit). In contrast to most essential oils, it is extracted as a by-product of orange juice production by centrifugation, producing a cold-pressed oil. It is composed of mostly d-limonene. This oil has been investigated and shown to reduce anxiety and improve mood before various interventions.The anxiolytic effects of these essential oils has not been investigated for parents with children undergoing pediatric dental procedures under sedation.

The aim of this study is to investigate the effects of lavender oil and orange oil diffused in the perioperative waiting room of parents with children under sedation.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be the parent of a child undergoing pediatric procedures under deep sedation.

To be over 18 years old. Volunteering to fill pre-operative anxiety tests.

Exclusion Criteria:

Hypersensitivity to lavender/orange and its products. Being on any medication. Being a psychiatric or psychological problem and being under treatment. Current upper airway infection or asthma story. Not want to be involved in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention; No mist will be diffused into the environment.
Active Comparator: Lavender; 0,3 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).	Behavioral: Lavender/Orange; A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.
Active Comparator: Orange; 0,3 ml orange oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).	Behavioral: Lavender/Orange; A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of preoperative anxiety	State Trait Anxiety Inventory (STAI) questionnaire will be applied. Turkish STAI consists of 2 questionnaires. The first survey measures state anxiety, while the second survey measures continuing anxiety(20 questions each).The STAI is a self-assessing and self-reporting anxiety questionnaire. The reliability and validity of the questionnaire are proven by numerous studies and the Turkish version is a reliable and valid questionnaire. All questions are rated on a 4-point scale (from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). Test-retest coefficients for this measure in the present study ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (Spielberger, 1989).	STAI will be applied at administration and after 1 hour waiting time.

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Perioperative Anxiety; Lavender Oil; Orange Oil; Pediatric Dentistry; Deep Sedation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 09/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No