Anxiolytic Effects of Lavender and Oran… | Clinical Trial

Key information

Conditions

Anxiety State Anesthesia Anxiety Disorders Dental Anxiety Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Oil; Inhalation Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Lavender/Orange

Behavioral

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.

Primary outcomes

Reduction of preoperative anxiety

Time frame: STAI will be applied at administration and after 1 hour waiting time.

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).

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Sep 6, 2019
Registry last updated: Jan 27, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed