Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 12/2/2017 |
Start Date: | September 11, 2017 |
End Date: | December 2020 |
Contact: | Sharon Harris |
Email: | sharris@radiology.bsd.uchicago.edu |
Phone: | 7737022777 |
Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study
Patients will be randomly assigned to one of two groups: the group exposed to NS, or the
standard care group exposed to supportive dialogue. Patients assigned to the former group
will be exposed to continuous NS throughout the CNB procedure.
standard care group exposed to supportive dialogue. Patients assigned to the former group
will be exposed to continuous NS throughout the CNB procedure.
For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5
min biopsy planning period during which only imaging occurs after patient positioning and
breast compression is complete, (2) One 2-min local anesthesia administration period during
which the skin is injected with local anesthetic and an incision is made to insert the biopsy
needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia
administration period during which imaging is obtained to confirm the position of the needle
with respect to the target, (4) One 1-minute sampling period when the breast tissue is
sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained
samples is confirmed and the need for additional sampling determined, and (6) One 2-minute
period during which a biopsy marker clip is deployed and pressure dressing placed on the
biopsy site.
For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline
5 min biopsy planning period during which only imaging occurs after patient is positioning,
(2) One 2-min local anesthesia administration period during which local anesthesia is given
at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local
anesthesia administration period during which intra-procedure imaging and confirmation of
adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during
which the biopsy device is advanced to the target for the first time and fired to acquire the
first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass
while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6)
One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure
dressing placed on the biopsy site.
The total time for a single site CNB is approximately 30 minutes when performed under
US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added
physiological recordings for this experiment are not expected to significantly prolong the
duration of CNB procedures.
min biopsy planning period during which only imaging occurs after patient positioning and
breast compression is complete, (2) One 2-min local anesthesia administration period during
which the skin is injected with local anesthetic and an incision is made to insert the biopsy
needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia
administration period during which imaging is obtained to confirm the position of the needle
with respect to the target, (4) One 1-minute sampling period when the breast tissue is
sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained
samples is confirmed and the need for additional sampling determined, and (6) One 2-minute
period during which a biopsy marker clip is deployed and pressure dressing placed on the
biopsy site.
For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline
5 min biopsy planning period during which only imaging occurs after patient is positioning,
(2) One 2-min local anesthesia administration period during which local anesthesia is given
at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local
anesthesia administration period during which intra-procedure imaging and confirmation of
adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during
which the biopsy device is advanced to the target for the first time and fired to acquire the
first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass
while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6)
One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure
dressing placed on the biopsy site.
The total time for a single site CNB is approximately 30 minutes when performed under
US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added
physiological recordings for this experiment are not expected to significantly prolong the
duration of CNB procedures.
Inclusion Criteria:
- 1) ≥ 21 years old
- 2) present for CNB
- 3) to be able to read and speak English
- 4) provide written informed consent.
Exclusion Criteria:
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-1559
University of Chicago One of the world's premier academic and research institutions, the University of...
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