Effect of Aromatherapy on Venopuncture Pain and Anxiety

March 18, 2016 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation

The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60100
        • Gaziosmanpasa University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be scheduled for elective surgery
  • be accepted to inhale lavender

Exclusion Criteria:

  • age <18 years >65 years
  • preoperative pain or consumption of analgesic medication
  • anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
  • pregnancy or breastfeeding
  • asthma, chronic obstructive pulmonary disease
  • poor sense of smell
  • allergy to the lavender essential oil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy with lavender essential oil
The 2 drops of lavender essential oil will put on 5x5 cm gauze and the patient will inhale it for 5 minutes and during peripheral venous cannulation.
Procedure: peripheral venous cannulation
The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
Other Names:
  • cannulation
Procedure: Aromatherapy with lavender essential oil
The two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
Other Names:
  • lavender
Placebo Comparator: Placebo
The 2 drops water will put on 5x5 cm gauze ant the patient will inhale it for 5 minutes and during peripheral venous cannulation.
Procedure: peripheral venous cannulation
The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
Other Names:
  • cannulation
Procedure: Placebo
The two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: Within the first 5 minutes after the peripheral venous cannula insertion process
The pain of the patients during cannulation will be measured with Visual Analog Scale from 0 to 10.
Within the first 5 minutes after the peripheral venous cannula insertion process

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Within the first 5 minutes after the peripheral venous cannula insertion process
The anxiety of the patient during cannulation will be measured with Visual Analog Scale from 0 to 10.
Within the first 5 minutes after the peripheral venous cannula insertion process
Patient Satisfaction
Time Frame: Within the first 15 minutes after the peripheral venous cannula insertion process
The patients' satisfaction will be measured with 5-point likert scale with 0 to 4.
Within the first 15 minutes after the peripheral venous cannula insertion process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Venpuncture pain

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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