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Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

Primary Purpose

Preoperative Anxiety

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Lavender Oil on Nasal Strip (Lx)

Strip without Lavender Oil (Px)

Propofol 1 % Injectable Suspension

About this trial

This is an interventional prevention trial for Preoperative Anxiety focused on measuring Lavender Oil,, Propofol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University Kebangsaan Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Strip with Lavender Oil (Lx)

Strip without Lavender Oil (Px)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03460145

First Posted

January 24, 2018

Last Updated

May 19, 2019

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT03460145

Brief Title

Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 27, 2018 (Actual)

Primary Completion Date

December 10, 2018 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preoperative Anxiety

Keywords

Lavender Oil,, Propofol

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Strip with Lavender Oil (Lx)

Arm Type

Experimental

Arm Description

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

Arm Title

Strip without Lavender Oil (Px)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Lavender Oil on Nasal Strip (Lx)

Intervention Description

Usage of Aromatherapy for Preoperative Anxiety

Intervention Type

Other

Intervention Name(s)

Strip without Lavender Oil (Px)

Intervention Description

Strip without Lavender Oil (Px)

Intervention Type

Drug

Intervention Name(s)

Propofol 1 % Injectable Suspension

Intervention Description

Propofol 1% (10mg/mL)

Primary Outcome Measure Information:

Title

1. Visual Analog Scoring for Anxiety

Description

Time Frame

1 day

Secondary Outcome Measure Information:

Title

1. Amount of sedation used to achieve Loss of Consciousness

Description

Time Frame

Less than 30minutes

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

For General Surgery

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raha Abdul Rahman, MD

Organizational Affiliation

Consultant Anesthesiologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Kebangsaan Malaysia

City

Kuala Lumpur

State/Province

Cheras

ZIP/Postal Code

56000

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

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