NCT03388736

Brief Summary

The aim of this study is to determine the possible reducing effects of different concentrations of lavender oil on preoperative anxiety in orthognathic surgery patients who have high anxiety during preoperative wait.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

December 8, 2017

Last Update Submit

July 2, 2019

Conditions

Keywords

preoperativeanxietyorthognathic surgerylavender oil

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.The State and Trait Anxiety Inventory-STAI (State and Trait Anxiety Scale) 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.

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

Study Arms (3)

No lavender

NO INTERVENTION

No mist will be diffused into the environment.

0,1 lavender

ACTIVE COMPARATOR

0,1 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).

Behavioral: Supplementary Medicine

0,3 lavender

ACTIVE COMPARATOR

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: Supplementary Medicine

Interventions

A diffuser containing 120 ml water and 0.1 or 0.3 ml lavender oil (according to arm) will be set into the patients' rooms to mist at least 30 minutes before the patients arrive.

0,1 lavender0,3 lavender

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To undergo orthognathic surgery
  • To be over 18 years old.
  • Volunteering to fill pre-operative anxiety tests

You may not qualify if:

  • Hypersensitivity to lavender 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 work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, 06940, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Poyzan Bozkurt, DDS PhD

    Ankara University Faculty of Dentistry

    STUDY DIRECTOR

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
Specialist

Study Record Dates

First Submitted

December 8, 2017

First Posted

January 3, 2018

Study Start

November 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations