Anxiolytic Effects of Lavender and Orange Oil
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 3, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedJanuary 27, 2020
January 1, 2020
5 months
September 3, 2019
January 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
No Intervention
NO INTERVENTIONNo mist will be diffused into the environment.
Lavender
ACTIVE COMPARATOR0,3 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).
Orange
ACTIVE COMPARATOR0,3 ml orange oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Faculty of Dentistry
Ankara, 06560, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
September 3, 2019
First Posted
September 6, 2019
Study Start
August 1, 2019
Primary Completion
December 20, 2019
Study Completion
January 15, 2020
Last Updated
January 27, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share