Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276505
Collaborator
(none)
150
1
3
10
15

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lavender Aromatherapy Tablet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled StudyRandomized Controlled Study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Efficacy of Two Different Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. State 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)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yasemin Uslu İstanbul Ataşehir Turkey 34752

    Sponsors and Collaborators

    • Acibadem University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acibadem University, Asisst. Prof., Acibadem University
    ClinicalTrials.gov Identifier:
    NCT05276505
    Other Study ID Numbers:
    • ATADEK 2021-14/18
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Acibadem University, Asisst. Prof., Acibadem University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2022