Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

July 5, 2023 updated by: Acibadem University

Evaluation of the Efficacy of Two Different Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

A breast biopsy is a cause for anxiety for most women when faced with a diagnosis of breast cancer. Physiological and psychological effects of breast biopsy may continue in the pre-biopsy and post-biopsy period. The aim of this study is to compare the effectiveness of two different aromatherapy methods applied in reducing anxiety before breast biopsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anxiety level was evaluated according to objective criteria by pretesting and posttesting lavender, lavender-mint and odorless (placebo) aromatherapy tablets applied before the biopsy in patients scheduled for breast biopsy.

The study was conducted with 135 patients, 90 of whom were in the experimental group and 45 in the control group. Patients were randomly assigned to the experimental and control groups according to their sequence numbers.

Before the biopsy, lavender aromatherapy and lavender-mint aromatherapy tablets were administered to the experimental group, and an odorless (placebo) aromatherapy tablet to the control group. Aromatherapy tablets 20 minutes after the procedure. First, a small (approximately 1x 0.5 inch), rectangular, absorbent, self-adhesive tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level. Research data were collected with the "Spielberger State Anxiety Scale" to determine the level of anxiety before and after breast biopsy.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

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
    • Ataşehir
      • İstanbul, Ataşehir, Turkey, 34752
        • Yasemin Uslu

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • over 18 years old
  • Female patients scheduled for breast biopsy (stereotactic biopsy, ultrasound biopsy, magnetic resonance imaging biopsy)
  • Individuals who can speak, understand and communicate in Turkish will be included in the study.

Exclusion Criteria:

  • Pregnant and lactating women,
  • Patients who are allergic to plants (lavender/lavender-mint),
  • Patients with a diagnosis of psychiatric illness, migraine, chronic headache or sense of smell
  • Patients who have difficulty breathing through their nose
  • People who can't smell, who are sensitive to smells or smells
  • Patients with a history of asthma, epilepsy or seizures as a precaution.
  • Patients with active wheezing
  • Patients with cognitive, verbal or hearing problems that may affect communication

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group - Standardized care

Standardized nursing care applications

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure
Experimental: Experimental Group- Lavender Aromatherapy Tablet

Before 20 minutes from breast biopsy. Lavender aromatherapy tablets. A small (approximately 1x 0.5 inch), rectangular, absorbent tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level in the waiting room.

Patients were asked to inhale the aromatherapy tablet for 20 minutes before the procedure.

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure
Other: Lavender Aromatherapy Tablet
Before the breast biopsy, aromatherapy tablets was adhered to the patient's shoulder in the waiting room and were asked to sniff
Other Names:
  • Lavender-Mint Aromatherapy Tablet
Experimental: Experimental Group- Lavender-Mint Aromatherapy Tablet

Before 20 minutes from breast biopsy. Lavender-Mint aromatherapy tablets. A small (approximately 1x 0.5 inch), rectangular, absorbent tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level in the waiting room.

Patients were asked to inhale the aromatherapy tablet for 20 minutes before the procedure.

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure
Other: Lavender Aromatherapy Tablet
Before the breast biopsy, aromatherapy tablets was adhered to the patient's shoulder in the waiting room and were asked to sniff
Other Names:
  • Lavender-Mint Aromatherapy Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Level
Time Frame: Evaluation of the differences between anxiety scales score - The scale is filled in 2 times - before breast biopsy (1), and after immediately breast biopsy (2)
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level
Evaluation of the differences between anxiety scales score - The scale is filled in 2 times - before breast biopsy (1), and after immediately breast biopsy (2)

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Study Director: Yasemin Uslu, Asisst Prof, Acıbadem Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2021-14/18

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

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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