Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

NCT05276505 | Completed

• 1 other identifier: ATADEK 2021-14/18
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Relations, Nurse; Patient Satisfaction; Anxiety State; Breast Cancer

Keywords

breast cancer; aromatherapy; anxiety

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Control Group - Standardized care

NO INTERVENTION

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 Group- Lavender Aromatherapy Tablet

EXPERIMENTAL

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

Experimental Group- Lavender-Mint Aromatherapy Tablet

EXPERIMENTAL

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

Interventions

Lavender Aromatherapy Tablet OTHER

Before the breast biopsy, aromatherapy tablets was adhered to the patient's shoulder in the waiting room and were asked to sniff

Also known as: Lavender-Mint Aromatherapy Tablet

Experimental Group- Lavender Aromatherapy Tablet; Experimental Group- Lavender-Mint Aromatherapy Tablet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Yasemin Uslu

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28395396 RESULT

• 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.

  PMID: 27555173 RESULT

• 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.

  PMID: 33942405 RESULT

• 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.

  PMID: 30660371 RESULT

• 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.

  PMID: 30205934 RESULT

MeSH Terms

Conditions

Patient Satisfaction; Anxiety Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yasemin Uslu, Asisst Prof

  Acıbadem Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof.

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 11, 2022
• Study Start: July 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)