Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia

NCT ID: NCT03460145

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2019-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Strip with Lavender Oil (Lx)

Application of Nasal Strip with essential oil (Lavender), 20minutes before induction.

VAS- Anxiety scores pre and post inhalation.

Group Type EXPERIMENTAL

Lavender Oil on Nasal Strip (Lx)

Intervention Type OTHER

Usage of Aromatherapy for Preoperative Anxiety

Propofol 1 % Injectable Suspension

Intervention Type DRUG

Propofol 1% (10mg/mL)

Strip without Lavender Oil (Px)

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

Group Type PLACEBO_COMPARATOR

Strip without Lavender Oil (Px)

Intervention Type OTHER

Strip without Lavender Oil (Px)

Propofol 1 % Injectable Suspension

Intervention Type DRUG

Propofol 1% (10mg/mL)

Interventions

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Lavender Oil on Nasal Strip (Lx)

Usage of Aromatherapy for Preoperative Anxiety

Intervention Type OTHER

Strip without Lavender Oil (Px)

Strip without Lavender Oil (Px)

Intervention Type OTHER

Propofol 1 % Injectable Suspension

Propofol 1% (10mg/mL)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raha Abdul Rahman, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Anesthesiologist

Locations

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University Kebangsaan Malaysia

Kuala Lumpur, Cheras, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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37839

Identifier Type: -

Identifier Source: org_study_id

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