Breast CancerNCT05656612
The Effect of Education Given at Different Times Before a Breast Biopsy
A study testing Written, Oral and Visual Education in people with Breast Cancer and Educational Problems, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Educational Problems, Bypass Complication
- What is being tested?
- Written, Oral and Visual Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who had major hearing, vision, or speech impairments or those who used antidepressants or anxiolytic drugs were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Keçiören, 6010
About this study
Official title: The Effect of Education Given at Different Times Before a Breast Biopsy on Anxiety, Readiness for the Procedure, Satisfaction, and Pain Levels in Women: A Randomized Study
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.
Read the detailed description
INTRODUCTION Breast cancer has the highest incidence among women worldwide. Of the three methods (physical examination, imaging, and biopsy) in the diagnosis of breast lesions and breast cancer, the biopsy is a frequently used standard. A breast biopsy is a safe and effective diagnostic method, but it causes pain and anxiety, especially for those who will have a biopsy for the first time. Considering the clinically significant anxiety levels experienced by women before a biopsy, it is necessary to develop strategies to help them manage their anxiety better. Various studies have shown that uncertainty about the biopsy procedure is associated with high levels of anxiety, and women experience less anxiety and other negative emotions if they are given reassuring information about the procedure. However, no study has been found in the literature regarding the optimal time for patient education to be planned for a breast biopsy. There is a need to determine the most accurate time for patient education. Although there are many studies on education methods to reduce anxiety and other related problems before interventional procedures, the optimal time for this education is still being debated. It is considered that there is a need for research into determining the most effective education time for patient education to be given before a breast biopsy.
RESEARCH QUESTION AND OBJECTIVES Although the effectiveness of educational interventions in reducing the anxiety and pain levels of patients and increasing their readiness and satisfaction for the procedure before a breast biopsy has been shown, very little is known about the optimal time for this educational intervention. Knowledge of the optimal education time will both increase patient comfort in the best way and help us to manage the personnel workforce and cost in the best way. Therefore, this study was conducted to evaluate the effects of patient education given at different times before a breast biopsy on anxiety, readiness for the procedure, pain, and satisfaction levels in women.
Hypotheses of the Research:
H0: There is no difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.
H1: There is a difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.
METHOD
Study design:
This is a single-center, randomized clinical trial. It was conducted in the radiology clinic of a training and research hospital between August 2020 and October 2020. This article follows the requirements of CONSORT statement.
Ethical aspects:
At the outset, the permission of the Non-Interventional Research Ethics Committee (decision no: 2020-01/515) and the hospital where the research was conducted was obtained. Patients who met the inclusion criteria were informed about the scope of the study. Verbal and written consent was obtained from the participants.
Participants:
The study sample consisted of women who presented to the aforementioned hospital between August 2020 and October 2020 for a breast biopsy appointment. The sample size was calculated as a total of 54 patients in three groups, based on a 95% confidence interval (1-α), 95% test power (1-β), and an effect size of d=0.826 by considering the mean anxiety values before and after the application in each group according to a similar study. Assuming a 10% loss, the final minimum sample size in the 3 groups was calculated as 60 individuals.
Randomization:
Randomization was made by the researcher by creating a random number sequence in the Microsoft Excel program. The generated random number sequence was divided into 3 research groups and the patients who came to the hospital for the procedure were assigned to the groups according to this list by the researcher.
Blinding:
Patients were informed about the purpose of the study, and all data were collected by the same researcher. Due to the study design, the researcher could not be blinded, but since all participants received education at different times, they did not know which group they were in.
Educational material:
The educational material developed in line with the literature and clinical data was designed as the Breast Biopsy Education Manual and Breast Biopsy Education Video. The content of the education included the definition of breast biopsy, the introduction of the biopsy room, the position of the patient during the procedure, the steps of the procedure, things to consider after the procedure considerations and recommendations, possible risks after the procedure, time to get results, and contact information. The pictures and photographs used in the education booklet and video were prepared by the researcher. Four faculty members in the field of nursing and a specialist in medicine were consulted about the language intelligibility and content of the education.
Implementation of the education program:
The planned patient education was carried out in a room reserved for education. First, participants were given information about the breast biopsy procedure, the education booklet was introduced, and the video, specially prepared for this program, was watched on a personal computer. Patients examined the education booklet. At the same time, patients' questions on the subject were answered by the researcher during the education. The education session took approximately 15 minutes. At the end of the education, patients were told that they could take the booklets home.
The study was carried out in two stages. The first stage was performed when patients came to the radiology clinic to make an appointment for a breast biopsy (approximately 1-2 weeks before the procedure), and the second stage was performed on the day of the procedure.
Stage 1: At this stage, necessary data were collected by the researcher from all the participants by using the data collection forms. The readiness levels of the patients were assessed with the "VAS". Physiological parameters (blood pressure, pulse, and respiratory rate) were measured and recorded with the same device for all patients by the same researcher. All of the participants were routinely informed about what they needed to do before coming to the procedure. After the data collection forms and provision of routine information were completed, the patients were randomized into 3 groups. Women in the first and third groups were given education.
Stage 2: This stage was carried out on the day of the breast biopsy procedure. The women in the second and third groups were given education on the day of the procedure. At this stage, all participants were asked to respond to the State Anxiety Inventory again just before the procedure, and data about the level of readiness and vital signs were recorded before the procedure. After the breast biopsy procedure, data on satisfaction with the procedure, pain, and physiological parameters of all research groups were recorded.
- Conditions
- Breast Cancer, Educational Problems, Bypass Complication
- Being tested
- Written, Oral and Visual Education
- Keywords
- breast biopsy, anxiety, pain, satisfaction, patient education, nursing
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written, Oral and Visual EducationOther
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.
Written, Oral and Visual EducationOther
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.
Written, Oral and Visual EducationOther
Before the initial training was given, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Written, Oral and Visual Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial state anxiety level
State anxiety levels of patients
Measured: It was evaluated 1-2 weeks before the breast biopsy.
change anxiety level
State anxiety levels of patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It was evaluated once day of the procedure, after breast biopsy procedure.
change readiness level
patients' level of readiness for the procedure
Measured: It was evaluated day of the procedure, just before the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Aug 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Cil, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656612
- Sponsor's protocol ID
- Breast Biopsy
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given at Different Times Before a Breast Biopsy on Anxiety, Readiness for the Procedure, Satisfaction, and Pain Levels in Women: A Randomized Study
- ClinicalTrials.gov ID
- NCT05656612
- Acronym / sponsor ID
- Breast Biopsy
- Conditions
- Breast Cancer, Educational Problems, Bypass Complication
- Keywords
- breast biopsy, anxiety, pain, satisfaction, patient education, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION Breast cancer has the highest incidence among women worldwide. Of the three methods (physical examination, imaging, and biopsy) in the diagnosis of breast lesions and breast cancer, the biopsy is a frequently used standard. A breast biopsy is a safe and effective diagnostic method, but it causes pain and anxiety, especially for those who will have a biopsy for the first time. Considering the clinically significant anxiety levels experienced by women before a biopsy, it is necessary to develop strategies to help them manage their anxiety better. Various studies have shown that uncertainty about the biopsy procedure is associated with high levels of anxiety, and women experience less anxiety and other negative emotions if they are given reassuring information about the procedure. However, no study has been found in the literature regarding the optimal time for patient education to be planned for a breast biopsy. There is a need to determine the most accurate time for patient education. Although there are many studies on education methods to reduce anxiety and other related problems before interventional procedures, the optimal time for this education is still being debated. It is considered that there is a need for research into determining the most effective education time for patient education to be given before a breast biopsy.
RESEARCH QUESTION AND OBJECTIVES Although the effectiveness of educational interventions in reducing the anxiety and pain levels of patients and increasing their readiness and satisfaction for the procedure before a breast biopsy has been shown, very little is known about the optimal time for this educational intervention. Knowledge of the optimal education time will both increase patient comfort in the best way and help us to manage the personnel workforce and cost in the best way. Therefore, this study was conducted to evaluate the effects of patient education given at different times before a breast biopsy on anxiety, readiness for the procedure, pain, and satisfaction levels in women.
Hypotheses of the Research:
H0: There is no difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.
H1: There is a difference between patients who receive education 1-2 weeks before a breast biopsy, patients who receive education on the day of the procedure, and patients who receive repetitive education at both times in terms of anxiety, readiness, pain, and satisfaction levels.
METHOD
Study design:
This is a single-center, randomized clinical trial. It was conducted in the radiology clinic of a training and research hospital between August 2020 and October 2020. This article follows the requirements of CONSORT statement.
Ethical aspects:
At the outset, the permission of the Non-Interventional Research Ethics Committee (decision no: 2020-01/515) and the hospital where the research was conducted was obtained. Patients who met the inclusion criteria were informed about the scope of the study. Verbal and written consent was obtained from the participants.
Participants:
The study sample consisted of women who presented to the aforementioned hospital between August 2020 and October 2020 for a breast biopsy appointment. The sample size was calculated as a total of 54 patients in three groups, based on a 95% confidence interval (1-α), 95% test power (1-β), and an effect size of d=0.826 by considering the mean anxiety values before and after the application in each group according to a similar study. Assuming a 10% loss, the final minimum sample size in the 3 groups was calculated as 60 individuals.
Randomization:
Randomization was made by the researcher by creating a random number sequence in the Microsoft Excel program. The generated random number sequence was divided into 3 research groups and the patients who came to the hospital for the procedure were assigned to the groups according to this list by the researcher.
Blinding:
Patients were informed about the purpose of the study, and all data were collected by the same researcher. Due to the study design, the researcher could not be blinded, but since all participants received education at different times, they did not know which group they were in.
Educational material:
The educational material developed in line with the literature and clinical data was designed as the Breast Biopsy Education Manual and Breast Biopsy Education Video. The content of the education included the definition of breast biopsy, the introduction of the biopsy room, the position of the patient during the procedure, the steps of the procedure, things to consider after the procedure considerations and recommendations, possible risks after the procedure, time to get results, and contact information. The pictures and photographs used in the education booklet and video were prepared by the researcher. Four faculty members in the field of nursing and a specialist in medicine were consulted about the language intelligibility and content of the education.
Implementation of the education program:
The planned patient education was carried out in a room reserved for education. First, participants were given information about the breast biopsy procedure, the education booklet was introduced, and the video, specially prepared for this program, was watched on a personal computer. Patients examined the education booklet. At the same time, patients' questions on the subject were answered by the researcher during the education. The education session took approximately 15 minutes. At the end of the education, patients were told that they could take the booklets home.
The study was carried out in two stages. The first stage was performed when patients came to the radiology clinic to make an appointment for a breast biopsy (approximately 1-2 weeks before the procedure), and the second stage was performed on the day of the procedure.
Stage 1: At this stage, necessary data were collected by the researcher from all the participants by using the data collection forms. The readiness levels of the patients were assessed with the "VAS". Physiological parameters (blood pressure, pulse, and respiratory rate) were measured and recorded with the same device for all patients by the same researcher. All of the participants were routinely informed about what they needed to do before coming to the procedure. After the data collection forms and provision of routine information were completed, the patients were randomized into 3 groups. Women in the first and third groups were given education.
Stage 2: This stage was carried out on the day of the breast biopsy procedure. The women in the second and third groups were given education on the day of the procedure. At this stage, all participants were asked to respond to the State Anxiety Inventory again just before the procedure, and data about the level of readiness and vital signs were recorded before the procedure. After the breast biopsy procedure, data on satisfaction with the procedure, pain, and physiological parameters of all research groups were recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a single-center, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| The Group Given Training 1-2 Weeks Before The Procedure | Experimental | Other: Written, Oral and Visual EducationParticipants received breast biopsy procedure training once. 1-2 weeks before the breast biopsy procedure. |
| The group trained on the day of the procedure | Experimental | Other: Written, Oral and Visual EducationParticipants received one time breast biopsy procedure training. The day of the breast biopsy procedure. |
| Repetitive training group | Experimental | Other: Written, Oral and Visual EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who had major hearing, vision, or speech impairments or those who used antidepressants or anxiolytic drugs were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written, Oral and Visual EducationBefore 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. | Other | The Group Given Training 1-2 Weeks Before The Procedure |
| Written, Oral and Visual EducationBefore 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. | Other | The group trained on the day of the procedure |
| Written, Oral and Visual EducationBefore the initial training was given, 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. | Other | Repetitive training group |
Primary outcome
initial state anxiety level
Time frame: It was evaluated 1-2 weeks before the breast biopsy.
State anxiety levels of patients
change anxiety level
Time frame: It was evaluated on the day of breast biopsy.
State anxiety levels of patients
initial readiness level
Time frame: It was evaluated 1-2 weeks before the day of breast biopsy.
Patients' level of readiness for the breast biopsy was evaluated with the visual analog scale.
pain level
Time frame: It was evaluated once day of the procedure, after the breast biopsy procedure.
Pain felt during the breast biopsy was evaluated with the visual analog scale.
Satisfaction level with the procedure
Time frame: It was evaluated once day of the procedure, after breast biopsy procedure.
Satisfaction with the breast biopsy was evaluated.with the visual analog scale.
Satisfaction level with the education
Time frame: It was evaluated once day of the procedure, after breast biopsy procedure.
Satisfaction with the education was evaluated with the visual analog scale.
change readiness level
Time frame: It was evaluated day of the procedure, just before the procedure.
patients' level of readiness for the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written, Oral and Visual Education in people with Breast Cancer and Educational Problems, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
initial state anxiety level (time frame: It was evaluated 1-2 weeks before the breast biopsy.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.