NCT03460145

Brief Summary

Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 21, 2019

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

January 24, 2018

Last Update Submit

May 19, 2019

Conditions

Preoperative Anxiety

Keywords

Lavender Oil,Propofol

Outcome Measures

Primary Outcomes (1)

  • 1. Visual Analog Scoring for Anxiety

    Self reported anxiety score before and after inhalation of aromatherapy. 3 questions about preoperative anxiety are asked and scoring is done based on a 0-10cm scale (0= no anxiety, 10= agonizing anxiety). Cumulative scores for all 3 questions above 5 indicates preoperative anxiety.

    1 day

Secondary Outcomes (1)

  • 1. Amount of sedation used to achieve Loss of Consciousness

    Less than 30minutes

Study Arms (2)

Strip with Lavender Oil (Lx)

EXPERIMENTAL

Application of Nasal Strip with essential oil (Lavender), 20minutes before induction. VAS- Anxiety scores pre and post inhalation.

Other: Lavender Oil on Nasal Strip (Lx)Drug: Propofol 1 % Injectable Suspension

Strip without Lavender Oil (Px)

PLACEBO COMPARATOR

Application of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo.

Other: Strip without Lavender Oil (Px)Drug: Propofol 1 % Injectable Suspension

Interventions

Lavender Oil on Nasal Strip (Lx)OTHER

Usage of Aromatherapy for Preoperative Anxiety

Strip with Lavender Oil (Lx)
Strip without Lavender Oil (Px)OTHER

Strip without Lavender Oil (Px)

Strip without Lavender Oil (Px)
Propofol 1 % Injectable SuspensionDRUG

Propofol 1% (10mg/mL)

Strip with Lavender Oil (Lx)Strip without Lavender Oil (Px)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFor General Surgery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Female

You may not qualify if:

  • Patients on B-blockers and or antidepressants.
  • BMI \> 35kg/m2
  • History of atopy
  • History of alcoholism, substance abuse, smoking
  • Patients with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Kebangsaan Malaysia

Kuala Lumpur, Cheras, 56000, Malaysia

Location

MeSH Terms

Interventions

lavender oilPropofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Raha Abdul Rahman, MD

    Consultant Anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

March 9, 2018

Study Start

September 27, 2018

Primary Completion

December 10, 2018

Study Completion

January 1, 2019

Last Updated

May 21, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)