Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy
NCT ID: NCT05276505
Last Updated: 2023-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
135 participants
INTERVENTIONAL
2021-07-01
2023-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy
NCT05658367
Aromatherapy in the Treatment of Early Breast Cancer
NCT06435104
Breast Cancer and Kinesiophobia and Physical Activity
NCT05090098
Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures
NCT05102331
Postoperative Pain, Central Sensitization, and Sleep Quality in Breast Cancer Surgery Patients
NCT07077421
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
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
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
85 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acibadem University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Acibadem University
Asisst. Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yasemin Uslu, Asisst Prof
Role: STUDY_DIRECTOR
Acıbadem Üniversitesi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yasemin Uslu
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATADEK 2021-14/18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.