Clinical trial NCT05276505: Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy
Official title: Evaluation of the Efficacy of Two Different Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Relations, Nurse
Patient Satisfaction
Anxiety State
Breast Cancer
Keywords: breast cancer
aromatherapy
anxiety
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: State Anxiety Level
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yasemin Uslu
state: Ataşehir
Study officials:
affiliation: Acıbadem Üniversitesi
name: Yasemin Uslu, Asisst Prof
role: STUDY_DIRECTOR
References:
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. Epub 2017 Apr 10.
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;33:243-9. doi: 10.1016/j.jclinane.2016.02.032. Epub 2016 May 5.
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. Epub 2021 May 3.
citation: 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.
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.