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Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

Primary Purpose

Patient Relations, Nurse, Patient Satisfaction, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender Aromatherapy Tablet
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Relations, Nurse focused on measuring breast cancer, aromatherapy, anxiety

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Yasemin Uslu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group - Standardized care

Experimental Group- Lavender Aromatherapy Tablet

Experimental Group- Lavender-Mint Aromatherapy Tablet

Arm Description

Standardized nursing care applications Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2022
Last Updated
July 5, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05276505
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Relations, Nurse, Patient Satisfaction, Anxiety State, Breast Cancer
Keywords
breast cancer, aromatherapy, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group - Standardized care
Arm Type
No Intervention
Arm Description
Standardized nursing care applications Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure
Arm Title
Experimental Group- Lavender Aromatherapy Tablet
Arm Type
Experimental
Arm Description
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
Arm Title
Experimental Group- Lavender-Mint Aromatherapy Tablet
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Lavender Aromatherapy Tablet
Other Intervention Name(s)
Lavender-Mint Aromatherapy Tablet
Intervention Description
Before the breast biopsy, aromatherapy tablets was adhered to the patient's shoulder in the waiting room and were asked to sniff
Primary Outcome Measure Information:
Title
State Anxiety Level
Description
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
Time Frame
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Uslu, Asisst Prof
Organizational Affiliation
Acıbadem Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Yasemin Uslu
City
İstanbul
State/Province
Ataşehir
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28395396
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.
Results Reference
result
PubMed Identifier
27555173
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.
Results Reference
result
PubMed Identifier
33942405
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.
Results Reference
result
PubMed Identifier
30660371
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.
Results Reference
result
PubMed Identifier
30205934
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.
Results Reference
result

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Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

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