Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276505
• Other study ID #: ATADEK 2021-14/18
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: July 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Breast Cancer
• Patient Relations, Nurse
• Patient Satisfaction

Intervention

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

Locations

Country	Name	City	State
Turkey	Yasemin Uslu	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Beyliklioglu A, Arslan S. Effect of Lavender Oil on the Anxiety of Patients Before Breast Surgery. J Perianesth Nurs. 2019 Jun;34(3):587-593. doi: 10.1016/j.jopan.2018.10.002. Epub 2019 Jan 16. — View Citation

Franco L, Blanck TJ, Dugan K, Kline R, Shanmugam G, Galotti A, von Bergen Granell A, Wajda M. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial. J Clin Anesth. 2016 Sep;33:243 — View Citation

Jaruzel CB, Gregoski M, Mueller M, Faircloth A, Kelechi T. Aromatherapy for Preoperative Anxiety: A Pilot Study. J Perianesth Nurs. 2019 Apr;34(2):259-264. doi: 10.1016/j.jopan.2018.05.007. Epub 2018 Sep 8. — View Citation

Tola YO, Chow KM, Liang W. Effects of non-pharmacological interventions on preoperative anxiety and postoperative pain in patients undergoing breast cancer surgery: A systematic review. J Clin Nurs. 2021 Dec;30(23-24):3369-3384. doi: 10.1111/jocn.15827. E — View Citation

Trambert R, Kowalski MO, Wu B, Mehta N, Friedman P. A Randomized Controlled Trial Provides Evidence to Support Aromatherapy to Minimize Anxiety in Women Undergoing Breast Biopsy. Worldviews Evid Based Nurs. 2017 Oct;14(5):394-402. doi: 10.1111/wvn.12229. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety Level	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)