Trial Outcomes & Findings for Impact of Sensory Stimuli on Patient Preferences During Outpatient Surgery (NCT NCT02958826)
NCT ID: NCT02958826
Last Updated: 2019-02-15
Results Overview
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights.
Recruitment status
COMPLETED
Target enrollment
160 participants
Primary outcome timeframe
Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Smoke Evacuation Group
Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
|
Control Group
Control group with sham smoke evacuation.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants did not respond to this question
Baseline characteristics by cohort
| Measure |
Smoke Evacuation Group
n=80 Participants
Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction).
|
Control Group
n=80 Participants
Control group with sham smoke evacuation.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=79 Participants • Two participants did not respond to this question
|
0 Participants
n=79 Participants • Two participants did not respond to this question
|
0 Participants
n=158 Participants • Two participants did not respond to this question
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=79 Participants • Two participants did not respond to this question
|
24 Participants
n=79 Participants • Two participants did not respond to this question
|
51 Participants
n=158 Participants • Two participants did not respond to this question
|
|
Age, Categorical
>=65 years
|
52 Participants
n=79 Participants • Two participants did not respond to this question
|
55 Participants
n=79 Participants • Two participants did not respond to this question
|
107 Participants
n=158 Participants • Two participants did not respond to this question
|
|
Sex: Female, Male
Female
|
22 Participants
n=78 Participants • 10 participants did not answer this question
|
20 Participants
n=72 Participants • 10 participants did not answer this question
|
42 Participants
n=150 Participants • 10 participants did not answer this question
|
|
Sex: Female, Male
Male
|
56 Participants
n=78 Participants • 10 participants did not answer this question
|
52 Participants
n=72 Participants • 10 participants did not answer this question
|
108 Participants
n=150 Participants • 10 participants did not answer this question
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights.
Outcome measures
| Measure |
No Smoke Evacuation
n=80 Participants
No Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
Smoke Evacuation
n=80 Participants
Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
|---|---|---|
|
Effect of Surgical Lights on Patient Preference
Did not notice lights
|
37.7 percentage of participants
|
46.8 percentage of participants
|
|
Effect of Surgical Lights on Patient Preference
Were not bothered by lights
|
0.00 percentage of participants
|
1.3 percentage of participants
|
|
Effect of Surgical Lights on Patient Preference
Experience would not be improved if lights changed
|
0.00 percentage of participants
|
1.3 percentage of participants
|
PRIMARY outcome
Timeframe: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.Population: Frequency of participants.
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke.
Outcome measures
| Measure |
No Smoke Evacuation
n=80 Participants
No Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
Smoke Evacuation
n=80 Participants
Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
|---|---|---|
|
Effects of Surgical Smoke on Patient Preference
Did Not Notice Smoke Smell
|
71.8 percentage of participants
|
41.6 percentage of participants
|
|
Effects of Surgical Smoke on Patient Preference
Were Not Bothered by Smoke Smell
|
93.6 percentage of participants
|
75.0 percentage of participants
|
|
Effects of Surgical Smoke on Patient Preference
Would Not be More Satisfied with Smoke Evacuation
|
89.6 percentage of participants
|
77.3 percentage of participants
|
PRIMARY outcome
Timeframe: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds.
Outcome measures
| Measure |
No Smoke Evacuation
n=80 Participants
No Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
Smoke Evacuation
n=80 Participants
Smoke Evacuation Group, anonymous questionnaire administered
Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
|
|---|---|---|
|
Effect of Surgical Sounds on Patient Preference
Were not bothered by sounds
|
90.9 percentage of participants
|
88.2 percentage of participants
|
|
Effect of Surgical Sounds on Patient Preference
Did not notice sounds
|
51.9 percentage of participants
|
50.0 percentage of participants
|
|
Effect of Surgical Sounds on Patient Preference
Would not be more satisfied if sounds reduced
|
93.2 percentage of participants
|
84.2 percentage of participants
|
Adverse Events
Smoke Evacuation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place