Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

Lavender Aromatherapy; Its Effect on Preoperative Anxiety and Propofol Requirement for Anaesthesia.

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

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Other: Lavender Oil on Nasal Strip (Lx); Drug: Propofol 1 % Injectable Suspension; Other: Strip without Lavender Oil (Px)

Detailed Description

This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among Female patients coming for elective surgeries under General Anesthesia.

As a consequence of that, the effect is also evaluated on how that influences the amount of intravenous sedation is required during induction for General Anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Cheras
    • Kuala Lumpur, Cheras, Malaysia, 56000
      • University Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18-65
• Female

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strip with Lavender Oil (Lx); 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); Usage of Aromatherapy for Preoperative Anxiety; Drug: Propofol 1 % Injectable Suspension; Propofol 1% (10mg/mL)
Placebo Comparator: Strip without Lavender Oil (Px); Application of Nasal strip without essential oil, acting as placebo. VAS- Anxiety scores pre and post placebo.	Drug: Propofol 1 % Injectable Suspension; Propofol 1% (10mg/mL); Other: Strip without Lavender Oil (Px); Strip without Lavender Oil (Px)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Amount of sedation used to achieve Loss of Consciousness	Induction for general anesthesia using Target control Infusion of Propofol 1% (10mg/mL) using the Schnider protocol, administered via a TIVA Agilia infusion pump to achieve a target plasma concentration of 4mcg/ml until loss of consciousness.	Less than 30minutes

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Raha Abdul Rahman, MD, Consultant Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 19, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Propofol; Lavender Oil,
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 37839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No