NCT04115891

Brief Summary

The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 2, 2019

Last Update Submit

October 4, 2019

Conditions

Dental AnxietyAnxiety DisorderAromatherapy

Keywords

lavandulaphytotherapyaromatherapydental anxietyanaesthesia

Outcome Measures

Primary Outcomes (3)

  • Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)

    changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively

    through study completion an average of 9 months

  • Vital Sign Measurements - 2 (heart rate)

    changes in heart rate pre-operatively, intra-operatively, post-operatively

    through study completion an average of 9 months

  • Vital Sign Measurements - 3 (saturation)

    changes in saturation pre-operatively, intra-operatively, post-operatively

    through study completion an average of 9 months

Secondary Outcomes (3)

  • Anxiety Scale - Face Image Scale (FIS)

    through study completion an average of 9 months

  • Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)

    through study completion an average of 9 months

  • Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)

    through study completion an average of 9 months

Study Arms (2)

Lavender oil group

EXPERIMENTAL

100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)

Other: Anxiety scaleOther: Pain scale - 1Other: Pain scale - 2Behavioral: Inhalation

Control group

SHAM COMPARATOR

No application prior to interventions. No lavender oil inhalation. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation)

Other: Anxiety scaleOther: Pain scale - 1Other: Pain scale - 2

Interventions

Anxiety scaleOTHER

Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.

Control groupLavender oil group
Pain scale - 1OTHER

Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction

Control groupLavender oil group
Pain scale - 2OTHER

Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction

Control groupLavender oil group
InhalationBEHAVIORAL

lavender oil inhalation in a separate room for 3 minutes prior to interventions

Also known as: 100 % pure, high strength lavender oil inhalation
Lavender oil group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being between 6 and 12 years of age
  • children who are determined as Frankl 2, 3 or 4
  • intellectually sufficient to complete the anxiety scale
  • volunteer to take part in the study
  • whose parents were willing to participate into the study

You may not qualify if:

  • aged under 6
  • has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
  • common allergies or dental pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nazife Begüm KARAN

Ankara, Merkez, 83TR2WATUF, Turkey (Türkiye)

Location

Nazife Begüm KARAN

Rize, Merkez, 053100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, DDS, PhD

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

September 30, 2019

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations

TU(2)