Trial Outcomes & Findings for The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients (NCT NCT00941005)
NCT ID: NCT00941005
Last Updated: 2020-08-25
Results Overview
Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated. Nausea scores will be collected 30, 60, and 120 minutes after surgery.
COMPLETED
NA
122 participants
24 hours
2020-08-25
Participant Flow
Participant milestones
| Measure |
Electroacustimulation
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Baseline characteristics by cohort
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Data no longer exists
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
61 participants
n=7 Participants
|
122 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated. Nausea scores will be collected 30, 60, and 120 minutes after surgery.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Post-operative Nausea Scores
30 min post-op
|
NA participants
Data cannot be confirmed
|
NA participants
Data cannot be confirmed
|
|
Post-operative Nausea Scores
60 min post-op
|
NA participants
Data cannot be confirmed
|
NA participants
Data cannot be confirmed
|
|
Post-operative Nausea Scores
120 min post-op
|
NA participants
Data cannot be confirmed
|
NA participants
Data cannot be confirmed
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Incidence of Post-operative Emetic Events
|
0 incidence of emetic events
Standard Error 0
|
0 incidence of emetic events
Standard Error 0
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Number of Participants With Post-operative Need for Rescue Medications
|
NA Participants
Data cannot be confirmed
|
NA Participants
Data cannot be confirmed
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Time to Participant Discharge
|
NA minutes
Standard Error NA
Data cannot be confirmed
|
NA minutes
Standard Error NA
Data cannot be confirmed
|
PRIMARY outcome
Timeframe: 24 hours post-opPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Phone survey of nausea/vomiting symptoms was administered on postoperative day 1. The survey consists of 8 questions, including: 1) a query about whether or not participant has experienced nausea since returning home; 2) rate nausea severity on a scale of 1-10 (where 10 is the most severe); 3) a query about satisfaction of nausea control; 4) a question asking if they would use the same post-op nausea treatment again; 5) a query about what activities the participant has been unable to do since surgery; 6) whether or not the participant has taken prescription medicine for treatment of nausea since returning home; 7) whether or not participant has taken prescription medicine for treatment of pain since returning home; and 8) if yes for 6-7, which medications.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Participants will evaluate their postoperative pain score on a scale of 1-10 where 1 is the least pain and 10 is the most severe pain. Pain scores will be evaluated at 30, 60, and 120 minutes postop.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Postoperative Pain Scores
30 min post-op
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
|
Postoperative Pain Scores
60 min post-op
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
|
Postoperative Pain Scores
120 min post-op
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
NA score on a scale
Standard Error NA
Data cannot be confirmed
|
SECONDARY outcome
Timeframe: 24 hours post-opPopulation: Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.
Phone survey of post-op pain medication usage was administered on postoperative day 1.
Outcome measures
| Measure |
Electroacustimulation
n=61 Participants
Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.
Electroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
|
Control
n=61 Participants
Sham electroacustimulation device (turned off)
Standardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery
|
|---|---|---|
|
Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op
|
NA Participants
Data cannot be confirmed
|
NA Participants
Data cannot be confirmed
|
Adverse Events
Electroacustimulation
Control
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