Trial Outcomes & Findings for Accupressure of P6 to Reduce Nausea During Cesarean Section (NCT NCT04799587)
NCT ID: NCT04799587
Last Updated: 2025-06-06
Results Overview
Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).
COMPLETED
NA
200 participants
Intraoperative Period
2025-06-06
Participant Flow
200 consented 1 dropped out in the P6 treatment group.
Participant milestones
| Measure |
Sham Pressure Point
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sham Pressure Point
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Accupressure of P6 to Reduce Nausea During Cesarean Section
Baseline characteristics by cohort
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.6 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
35.3 Years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
35 Years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
99 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Height (cm)
|
163 centimeters
STANDARD_DEVIATION 7.5 • n=5 Participants
|
164 centimeters
STANDARD_DEVIATION 7.5 • n=7 Participants
|
163 centimeters
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Weight (kg)
|
86 Kilograms
STANDARD_DEVIATION 19 • n=5 Participants
|
89 Kilograms
STANDARD_DEVIATION 18 • n=7 Participants
|
87 Kilograms
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
31.6 kg/m^2
n=5 Participants
|
31.4 kg/m^2
n=7 Participants
|
31.5 kg/m^2
n=5 Participants
|
|
American Society of Anesthesiology (ASA) physical status n
ASA 2
|
74 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
American Society of Anesthesiology (ASA) physical status n
ASA 3
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Parity
0
|
15 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Parity
1
|
55 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Parity
2
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parity
3
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Prior cesarean delivery (n)
No prior cesarean delivery
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Prior cesarean delivery (n)
Yes, previous cesarean delivery
|
75 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Type of neuraxial anesthesia
Spinal
|
93 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Type of neuraxial anesthesia
Combined spinal epidural
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Initial BP in operating room (mmHg)
Systolic
|
136 mmHg
n=5 Participants
|
134 mmHg
n=7 Participants
|
135 mmHg
n=5 Participants
|
|
Initial BP in operating room (mmHg)
Diastolic
|
82 mmHg
n=5 Participants
|
79 mmHg
n=7 Participants
|
80 mmHg
n=5 Participants
|
|
History of nausea/vomiting
No
|
55 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
History of nausea/vomiting
Yes
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative PeriodPresence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Presence of Intraoperative Vomiting
|
17 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Intraoperative periodPresence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Presence of Intraoperative Nausea
|
57 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Reported number of emesis episodes based on number of subjects who experienced emesis . 17 in sham group and 17 in the P6 acupressure group.
The number of emesis episodes during the cesarean section intraoperative period.
Outcome measures
| Measure |
Sham Pressure Point
n=17 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=17 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Number of Emesis Episodes in the Intraoperative Period Period
|
2 Emesis episodes
Interval 1.0 to 4.0
|
2 Emesis episodes
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Number of antiemetic and/or anti-nausea medications administered in the intraoperative period.
Reported total number (count) of rescue antiemetics administered per group during the intraoperative period. Rescue antiemetics are defined as the use of intravenous administered prochlorperazine, promethazine, or metoclopramide.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting
|
10 Number of antiemetics per group
|
10 Number of antiemetics per group
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 hoursReported total number (count) of emesis episodes per group from admission to the post anesthesia care unit after the operative procedure to discharge from the hospital.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
The Number of Emesis From Post Anesthesia Care Unit to Discharge.
|
17 Emesis episodes
|
13 Emesis episodes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 hoursThe number(count) of antiemetic medication administered per group in the post anesthesia care unit through discharge from the hospital
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Antiemetic Medication Administered From the PACU Through Discharge
|
27 Doses administered
|
30 Doses administered
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question
Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced dry retching or vomiting?
Outcome measures
| Measure |
Sham Pressure Point
n=73 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=74 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Have You Experienced Dry Retching or Vomiting
Has experienced dry retching
|
3 Participants
|
10 Participants
|
|
Patient Questionnaire: Have You Experienced Dry Retching or Vomiting
Has experienced vomiting
|
20 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question
Patient recovery questionnaire administered prior to discharge from the hospital. (of those who indicated vomiting) How many times did you vomit.
Outcome measures
| Measure |
Sham Pressure Point
n=73 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=74 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Number of Times Vomited
|
2 Vomit episodes
Interval 1.0 to 4.0
|
2 Vomit episodes
Interval 1.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question
Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced nausea?
Outcome measures
| Measure |
Sham Pressure Point
n=73 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=74 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Number of Participants With Nausea
|
51 Participants
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question. 51 in the sham group and 53 in the P6 group reported nausea.
Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea)Describe the pattern of your nausea (2 choices).
Outcome measures
| Measure |
Sham Pressure Point
n=51 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=53 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Describe the Pattern of Your Nausea?
Nausea comes and goes
|
40 Participants
|
44 Participants
|
|
Patient Questionnaire: Describe the Pattern of Your Nausea?
Nausea is constant
|
5 Participants
|
2 Participants
|
|
Patient Questionnaire: Describe the Pattern of Your Nausea?
No response
|
6 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question. 51 in the sham group and 53 in the P6 group reported nausea.
Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How did the nausea interfere with your ability to care for yourself.
Outcome measures
| Measure |
Sham Pressure Point
n=51 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=53 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?
No interference
|
36 Participants
|
34 Participants
|
|
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?
A little interference
|
11 Participants
|
11 Participants
|
|
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?
Some of the time
|
1 Participants
|
2 Participants
|
|
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?
Most of the time
|
3 Participants
|
4 Participants
|
|
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?
No response
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question. 51 in the sham group and 53 in the P6 group reported nausea.
Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How many hours did the nausea last.
Outcome measures
| Measure |
Sham Pressure Point
n=51 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=53 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Duration of Nausea.
|
2 Hours
Interval 0.5 to 14.0
|
4 Hours
Interval 2.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 73 in the sham group and 74 in the P6 group completed the survey question. 51 in the sham group and 53 in the P6 group reported nausea.
Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea).Severity of nausea based on a 0 (none) -100 (very severe).
Outcome measures
| Measure |
Sham Pressure Point
n=51 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=53 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Severity of Nausea.
Highest level of nausea
|
50 score on a scale (0 good-100 severe)
Interval 18.0 to 70.0
|
63 score on a scale (0 good-100 severe)
Interval 29.0 to 78.0
|
|
Patient Questionnaire: Severity of Nausea.
Lowest level of nausea
|
4 score on a scale (0 good-100 severe)
Interval 0.0 to 17.0
|
4 score on a scale (0 good-100 severe)
Interval 0.0 to 23.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: Please note 62 in the sham group and 64 in the P6 group completed this survey question.
Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve nausea response yes or no.
Outcome measures
| Measure |
Sham Pressure Point
n=62 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=64 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Do You Think the Magnet Improves Nausea?
Improves nausea (yes)
|
23 Participants
|
25 Participants
|
|
Patient Questionnaire: Do You Think the Magnet Improves Nausea?
Does not improve nausea (no)
|
39 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: Please not that 60 in the sham group and 62 in the P6 group completed the survey question.
Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve vomiting response yes or no.
Outcome measures
| Measure |
Sham Pressure Point
n=60 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=62 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Do You Think the Magnet Improves Vomiting?
Improves vomiting (yes)
|
15 Participants
|
19 Participants
|
|
Patient Questionnaire: Do You Think the Magnet Improves Vomiting?
Does not improve vomiting (no)
|
45 Participants
|
43 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 96 HoursPopulation: 61 in the sham group and 65 in the P6 group completed the survey question.
Patient recovery questionnaire administered prior to discharge from the hospital. Are you satisfied with acupressure response yes or no.
Outcome measures
| Measure |
Sham Pressure Point
n=61 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=65 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Patient Questionnaire: Are You Satisfied With Acupressure?
Satisfied with acupressure (yes)
|
29 Participants
|
33 Participants
|
|
Patient Questionnaire: Are You Satisfied With Acupressure?
Not satisfied with acupressure (no)
|
32 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative periodLowest systolic and diastolic blood pressure during the intraoperative period.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Intraoperative Lowest BP (mmHg)
Systolic Blood Pressure
|
116 mm/Hg
Interval 106.0 to 124.0
|
111 mm/Hg
Interval 105.0 to 121.0
|
|
Intraoperative Lowest BP (mmHg)
Diastolic Blood Pressure
|
61 mm/Hg
Interval 56.0 to 69.0
|
60 mm/Hg
Interval 56.0 to 69.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative periodMeasure Description: Total vasopressor units expressed as phenylephrine units using an 80:1 ratio for ephedrine in micrograms.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Intraoperative Total Vasopressor (VPE) [1]
|
2052 micrograms
Interval 1288.0 to 2918.0
|
2190 micrograms
Interval 1550.0 to 2950.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeNumber of hypotension episodes experienced during the intraoperative period.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Intraoperative Hypotension Episodes (n)
|
1 Hypotension episodes
Interval 0.0 to 2.0
|
1 Hypotension episodes
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative periodAmount of crystalloid fluids given as a co-load in milliliters during the intraoperative period.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Intraoperative Crystalloid Co-load (mL)
|
500 Milliliters
Interval 300.0 to 600.0
|
500 Milliliters
Interval 300.0 to 600.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeTotal number of milliliters of fluids administered during the intraoperative period.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Intraoperative Fluids Administered (mL)
|
2000 Milliliters
Interval 1600.0 to 2175.0
|
1800 Milliliters
Interval 1500.0 to 2100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intraoperative periodDuration of administration of intraoperative anesthesia in minutes.
Outcome measures
| Measure |
Sham Pressure Point
n=100 Participants
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 Participants
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Duration of Intraoperative Anesthesia (Min)
|
81 Minutes
Interval 70.0 to 98.0
|
81 Minutes
Interval 73.0 to 103.0
|
Adverse Events
Sham Pressure Point
P6 Accupressure Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Pressure Point
n=100 participants at risk
The sham pressure point (distal to the P6 acupressure point).
Magnet applied to arm not at P6 pressure point.: Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
|
P6 Accupressure Group
n=99 participants at risk
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Magnet at P6: Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
57.0%
57/100 • Number of events 57 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
56.6%
56/99 • Number of events 56 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
|
Gastrointestinal disorders
Emesis during operative period
|
17.0%
17/100 • Number of events 43 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
17.2%
17/99 • Number of events 33 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
|
Gastrointestinal disorders
Emesis in post anesthesia care unit
|
4.0%
4/100 • Number of events 4 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
9.1%
9/99 • Number of events 9 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
|
Gastrointestinal disorders
Emesis (floor)
|
17.0%
17/100 • Number of events 17 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
13.1%
13/99 • Number of events 13 • 72 Hours
Adverse events were collected on a survey provided to the participant up to 72 hours after delivery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place