The Effect of Education Given at Different Times Before a Breast Biopsy
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Aug 2020
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedFirst Submitted
Initial submission to the registry
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedDecember 19, 2022
December 1, 2022
3 months
September 30, 2022
December 12, 2022
Conditions
Keywords
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
EXPERIMENTALParticipants received breast biopsy procedure training once. 1-2 weeks before the breast biopsy procedure.
The group trained on the day of the procedure
EXPERIMENTALParticipants received one time breast biopsy procedure training. The day of the breast biopsy procedure.
Repetitive training group
EXPERIMENTALParticipants 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.
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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- 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