NCT05656612

Brief Summary

Aim: This study was conducted to investigate the effect of education given at different times before a breast biopsy on anxiety, readiness for the procedure, pain, and satisfaction levels in women. Background: A breast biopsy is an invasive procedure that causes pain and anxiety. Patient education is an effective and evidence-based nursing intervention that reduces pain and anxiety levels. Design: The study is a single-center, uncontrolled randomized clinical trial. Method: Participants (n: 60) in the study were randomly assigned into three groups. The first group (n: 20) was given education about the breast biopsy 1-2 weeks before the procedure, the second group (n: 20) was given education on the day of the procedure, and the third group (n: 20) was given education at two different times, the first 1-2 weeks before the procedure and the second on the day of the procedure. Research data were collected by using a Descriptive Characteristics Form, the State Anxiety Inventory, and a Patient Assessment Form.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

September 30, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

breast biopsyanxietypainsatisfactionpatient educationnursing

Outcome Measures

Primary Outcomes (7)

  • initial state anxiety level

    State anxiety levels of patients

    It was evaluated 1-2 weeks before the breast biopsy.

  • change anxiety level

    State anxiety levels of patients

    It was evaluated on the day of breast biopsy.

  • initial readiness level

    Patients' level of readiness for the breast biopsy was evaluated with the visual analog scale.

    It was evaluated 1-2 weeks before the day of breast biopsy.

  • pain level

    Pain felt during the breast biopsy was evaluated with the visual analog scale.

    It was evaluated once day of the procedure, after the breast biopsy procedure.

  • Satisfaction level with the procedure

    Satisfaction with the breast biopsy was evaluated.with the visual analog scale.

    It was evaluated once day of the procedure, after breast biopsy procedure.

  • Satisfaction level with the education

    Satisfaction with the education was evaluated with the visual analog scale.

    It was evaluated once day of the procedure, after breast biopsy procedure.

  • change readiness level

    patients' level of readiness for the procedure

    It was evaluated day of the procedure, just before the procedure.

Study Arms (3)

The Group Given Training 1-2 Weeks Before The Procedure

EXPERIMENTAL

Participants received breast biopsy procedure training once. 1-2 weeks before the breast biopsy procedure.

Other: Written, Oral and Visual Education

The group trained on the day of the procedure

EXPERIMENTAL

Participants received one time breast biopsy procedure training. The day of the breast biopsy procedure.

Other: Written, Oral and Visual Education

Repetitive training group

EXPERIMENTAL

Participants received twice breast biopsy procedure training. The first training is 1-2 weeks before the breast biopsy procedure. The second training is the day of the breast biopsy procedure.

Other: Written, Oral and Visual Education

Interventions

Before the training, state anxiety levels were measured with a questionnaire. The pre-process measurement was repeated. Post-procedure pain and satisfaction levels were measured using a scale.

The Group Given Training 1-2 Weeks Before The Procedure

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women were studied for the breast biopsy procedure because all patients who come for the procedure are women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who were older than 18 years of age, had a breast biopsy for the first time, had no communication problems, and volunteered to participate in the study were included in the study.

You may not qualify if:

  • Women who had major hearing, vision, or speech impairments or those who used antidepressants or anxiolytic drugs were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Keçiören, 6010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsAnxiety DisordersPainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a single-center, randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

September 30, 2022

First Posted

December 19, 2022

Study Start

August 1, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations