Trial Outcomes & Findings for Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer (NCT NCT04822597)
NCT ID: NCT04822597
Last Updated: 2023-08-03
Results Overview
Post-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection
Results posted on
2023-08-03
Participant Flow
Participants from the UW Hospital and Clinics were enrolled from April 2021 to January 2022.
Participant milestones
| Measure |
Ice Pack
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
Lidocaine Patch
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Lidocaine patch: Lidocaine is a local anesthetic.
|
Lidocaine Patch and Buzzy(R)
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
Lidocaine patch: Lidocaine is a local anesthetic.
Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
|---|---|---|---|---|
|
Overall Study
Off Treatment As Assigned
|
44
|
37
|
35
|
34
|
|
Overall Study
STARTED
|
44
|
39
|
44
|
40
|
|
Overall Study
On Treatment As Assigned
|
44
|
37
|
35
|
34
|
|
Overall Study
Analyzed With Intent to Treat
|
43
|
37
|
42
|
38
|
|
Overall Study
COMPLETED
|
43
|
37
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ice Pack
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
Buzzy(R)
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
Lidocaine Patch
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection
Lidocaine patch: Lidocaine is a local anesthetic.
|
Lidocaine Patch and Buzzy(R)
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
Lidocaine patch: Lidocaine is a local anesthetic.
Buzzy(R): Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
Ice pack: Ice cools the skin and can provide some numbing for pain.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Subject withdrawn after enrollment
|
0
|
1
|
0
|
1
|
|
Overall Study
Surgery Re-scheduled, missed by study team
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer
Baseline characteristics by cohort
| Measure |
Ice Pack
n=44 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=39 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=44 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=40 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
30-39 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Customized
40-49 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Age, Customized
50-59 years
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Age, Customized
60-69 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Customized
70-79 years
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Age, Customized
80-89 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
167 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
39 participants
n=7 Participants
|
44 participants
n=5 Participants
|
40 participants
n=4 Participants
|
167 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injectionPost-procedural pain score on the Wong-Baker FACES scale. Scale from 0-10 with 0 being "no pain" and 10 being "worst pain".
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Median Post-Procedural Pain Score
|
2 score on a scale
Interval 2.0 to 6.0
|
2 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 2.0 to 6.0
|
4 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injectionSensory pain score out of 33 with 0 being "no pain" and 33 being severe sensory pain
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Short Form McGill Sensory Pain Score
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 5.0
|
2 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injectionAffective pain score out of 12 with 0 being "no pain" and 12 being severe affective pain
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Short Form McGill Affective Pain Score
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injectionVisual analog scale pain score out of 100 with zero being "no pain" and 100 being "worst possible pain"
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Short Form McGill VAS Pain Score
|
24 score on a scale
Interval 14.0 to 66.0
|
28 score on a scale
Interval 19.0 to 39.0
|
27 score on a scale
Interval 16.0 to 53.0
|
33 score on a scale
Interval 14.0 to 50.0
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injectionCombination of outcomes 2-3. Additive total score between 0 and 45 with zero being "no pain" and 45 being "severe pain"
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Short Form McGill Combined Pain Score
|
4 score on a scale
Interval 1.0 to 9.0
|
3 score on a scale
Interval 1.0 to 7.0
|
6 score on a scale
Interval 2.0 to 9.0
|
3 score on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Degree of Participant Satisfaction With Attention Paid to Complaints as Reported by Number of Participants Who Report Satisfied or Very Satisfied
|
42 Participants
|
37 Participants
|
42 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Degree of Participant Satisfaction With Care Provided During Injection as Reported by Number of Participants Who Report Satisfied or Very Satisfied
|
42 Participants
|
37 Participants
|
42 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection1-6 scale with 1 being "very satisfied" and 6 being "very dissatisfied". Reported are the number of participants satisfied or very satisfied.
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Degree of Participant Satisfaction With Pain Control as Reported by Number of Participants Who Report Satisfied or Very Satisfied
|
33 Participants
|
33 Participants
|
36 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection1-4 scale with 1 being "very anxious" and 4 being "not at all anxious", reported here are the number of participants rating anxiety at 2 or "moderate".
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Degree of Anxiety During the Injection as Measured by Number of Participants Moderately Anxious
|
33 Participants
|
24 Participants
|
32 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 3 hours of radioactive tracer injection"Yes", "No", "Not sure" with option for free response
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Recommendation of Pain Control Modality as Measured by Number of Participants Who Answered "Yes"
|
31 Participants
|
31 Participants
|
35 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day of surgery (last of two study visits), assessed within 30 minutes of radioactive tracer injection7 point single ease question to rate ease of a task. 1 being "very difficult" and 7 being "very easy". This is the provider's perception of the how easy the intervention was to administer.
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Provider Perceived Ease of Administration
|
7 score on a scale
Interval 6.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
7 score on a scale
Interval 6.0 to 7.0
|
6 score on a scale
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: Day of surgery, assessed within 30 minutes of radioactive tracer injection11 point numeric rating scale for perceived pain of others. 0 being "no pain" and 7-10 being "severe pain".
Outcome measures
| Measure |
Ice Pack
n=43 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=37 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=42 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=38 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Provider Perceived Participant Pain
|
3 score on a scale
Interval 3.0 to 6.0
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Assessed after last participant off study (up to 12.5 months)Population: There were 8 providers surveyed to rank the ease of use of the interventions, they were not consented as the IRB considered them 'study team members'
End of study survey to compare providers' perceived usability of intervention. Rank ordering of interventions 1-4 with 1 being "easiest to administer" and 4 being "hardest to administer".
Outcome measures
| Measure |
Ice Pack
n=8 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=8 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=8 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=8 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Provider Rank Ordering Ease of Use of Interventions
1 - easiest to administer
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Provider Rank Ordering Ease of Use of Interventions
2
|
7 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Provider Rank Ordering Ease of Use of Interventions
3
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Provider Rank Ordering Ease of Use of Interventions
4 - hardest to administer
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed after last participant off study (up to 12.5 months)Population: There were 8 providers that were not consented to the study because the IRB considered the 'study team members'
End of study survey to compare providers' perceived efficacy of intervention. Rank ordering of interventions 1-4 with 1 being "best pain control" and 4 being "least pain control".
Outcome measures
| Measure |
Ice Pack
n=8 Participants
Ice will be placed on the breast prior to radioactive tracer injection (usual treatment)
|
Buzzy(R)
n=8 Participants
A vibrating distraction device (Buzzy(R)) and ice will be placed on the breast prior to radioactive tracer injection.
|
Lidocaine Patch
n=8 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
|
Lidocaine Patch and Buzzy(R)
n=8 Participants
A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection. This will be removed and a vibrating distraction device (Buzzy(R)) and ice will be placed on the breast just prior to radioactive tracer injection.
|
|---|---|---|---|---|
|
Provider Rank Ordering Perceived Efficacy of Interventions
3
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Provider Rank Ordering Perceived Efficacy of Interventions
4 - worst pain control
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Provider Rank Ordering Perceived Efficacy of Interventions
2
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Provider Rank Ordering Perceived Efficacy of Interventions
1 - best pain control
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
Ice Pack
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buzzy(R)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine Patch and Buzzy(R)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heather B Neuman, MD, MS, FACS
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-7064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place