Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

NCT ID: NCT05276505

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Patient Relations, Nurse Patient Satisfaction Anxiety State Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

Lavender Aromatherapy Tablet

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Lavender Aromatherapy Tablet

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Lavender-Mint Aromatherapy Tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Acibadem University

Asisst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasemin Uslu, Asisst Prof

Role: STUDY_DIRECTOR

Acıbadem Üniversitesi

Locations

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Yasemin Uslu

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 28395396 (View on PubMed)

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.

Reference Type RESULT
PMID: 27555173 (View on PubMed)

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.

Reference Type RESULT
PMID: 33942405 (View on PubMed)

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.

Reference Type RESULT
PMID: 30660371 (View on PubMed)

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.

Reference Type RESULT
PMID: 30205934 (View on PubMed)

Other Identifiers

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ATADEK 2021-14/18

Identifier Type: -

Identifier Source: org_study_id

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