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Accupressure of P6 to Reduce Nausea During Cesarean Section

The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04799587
Enrollment
200
Registered
2021-03-16
Start date
2021-05-26
Completion date
2023-09-30
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery, Nausea, Pregnancy Related, Vomiting

Keywords

Accupressure, Cesarean Delivery, Nausea, Vomiting

Brief summary

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

Detailed description

After obtaining written informed consent from the subject. They were then randomized to either the P6 acupressure or a sham acupressure group. Envelopes containing group assignment information were prepared prior to the start of the study by research personnel not involved in this study. Randomization occurred by selecting a sealed envelope that contained the group assignment, two acupressure 0.09-inch by 0.2-inch diameter devices, and a diagram of where to place the device from a pool of 200 envelopes. The acupressure devices used in this study are also used in clinical practice by Northwestern Medicine Osher Center for Integrative Medicine (Plaster - Accu Band 800 NP Magnets, Japan). Prior to the commencement of the study, the Center for Integrative Medicine acupuncturists educated study personnel on the placement of the devices and the proper patient-initiated stimulation method when the subject began to perceive nausea. Device placement took place in the preoperative room, prior to walking to the operating room for the surgical procedure, by research personnel not involved in the clinical care of study subjects. In the P6 acupressure group, the devices were placed two inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus bilaterally. The small protrusion on the device was placed on the skin and held in place using an adhesive sticker at the stimulation point. In the sham acupressure group, the devices were placed distal and lateral to the P6 acupoint site, like in prior studies comparing the effectiveness of P6 acupressure to sham. This method of sham acupoint placement when compared to P6 acupoint placement has shown superiority of the P6 acupoint placement in 70% of studies that have used this point for sham.15 The devices are designed to maintain pressure at the point of placement without additional force applied. Research personnel also instructed subjects to apply additional pressure at the acupressure site for a period of 30 s-2 min if they perceived nausea. Subjects were then taken to the operating room where they received neuraxial anesthesia consisting of either a spinal anesthetic dosed with hyperbaric bupivacaine 12 mg plus fentanyl 15 mcg and morphine 150 mcg, or a combined spinal epidural with the same intrathecal dosing per institutional standard practice. Co-loading with a crystalloid solution occurred upon the start of the neuraxial procedure, and a phenylephrine infusion was started immediately after the cerebrospinal fluid was obtained. Maternal hypotension was defined as a systolic blood pressure less than 100 mmHg, mean arterial pressure less than 65 mmHg, or mean arterial pressure less than 20% of the baseline mean arterial pressure. The baseline blood pressure was considered the average value of three blood pressure readings obtained by the nursing staff in the preoperative area. Subjects were asked to report any nausea, retching, or vomiting to the anesthesia care team. In addition, the anesthesia provider asked the study subject about nausea or vomiting at intervals corresponding to events that are associated with a greater prevalence of nausea and vomiting (e.g. neuraxial dose administration, uterine exteriorization, and following uterotonic administration) as well as when the anesthesia provider observed the subject massaging the acupressure point. After the first complaint of nausea, subjects were encouraged to apply additional pressure to the devices, an intravenous (IV) fluid bolus was administered, and phenylephrine or ephedrine was administered by IV bolus and/or by increasing the infusion rate of phenylephrine if hypotension was present. At the second complaint of nausea or emesis, study subjects were again encouraged to apply additional pressure on the devices. Following delivery of the fetus, ondansetron 8 mg IV and dexamethasone 8 mg IV were administered. If intraoperative nausea and/or vomiting continued, study subjects were again encouraged to apply additional acupressure. If this was ineffective, prochlorperazine, promethazine, metoclopramide, fentanyl, or propofol were administered at the anesthesiologist's discretion. If these antiemetic agents were ineffective, the anesthesiologist could provide additional medications. Routine postoperative orders, including antiemetic medications as needed, were placed by the anesthesiology team for postpartum use per our institution's current standard of care. Postoperative medications were administered and documented by the nursing staff. Study subjects were also encouraged to use additional acupressure as needed throughout their postoperative course, for up to 48 h or until discharge, whichever came first. A study team member replaced devices that were lost or removed the device if the study subject requested it. Prior to discharge, subjects were visited by study personnel and asked to complete a survey asking them to describe the incidence, duration, and severity of nausea and vomiting, interference of nausea/vomiting with the ability to care for themselves, and their rating and satisfaction of the acupressure therapy. Baseline data collected were age, weight, height, body mass index, American Society of Anesthesiologists physical status classification, race, ethnicity, history of nausea and vomiting, parity, and the number of prior cesarean delivery. Intraoperative data included the type of neuraxial anesthesia, initial blood pressure in the operating room, the lowest recorded blood pressure intraoperatively, total vasopressor use (expressed as phenylephrine equivalents),18 the number of hypotensive episodes, crystalloid administered, and duration of anesthesia. Intraoperative nausea and vomiting outcomes included the number of subjects with nausea and/or vomiting, the number of emesis episodes, and the need for rescue antiemetic administration in the operating room. Post delivery emesis and antiemetic treatments were recorded in the post anesthesia care unit (PACU) in 0-24 h and 24-48 h periods. Study subject questionnaires were collected at the end of the study period.

Interventions

OTHERMagnet 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.

OTHERMagnet applied to arm not at P6 pressure point.

Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participant will not know whether the pressure point is correct or sham location.

Intervention model description

Two group, sham vs actual location of pressure point.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥18 years of age * English-speaking * Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (\>37 weeks' gestation) * Patients scheduled as ERAC * Parturients undergoing spinal anesthesia

Exclusion criteria

* Patients requiring emergent delivery, * Fetal demise * Patients with adhesive allergy/sensitivity * Patients with allergy/sensitivity to nickel, * Patients with inability to consent, * Patients with known abnormal placentation * Patients with pacemakers/defibrillators * Patients with positive COVID-19 tests

Design outcomes

Primary

MeasureTime frameDescription
Presence of Intraoperative VomitingIntraoperative PeriodPresence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).
Presence of Intraoperative NauseaIntraoperative periodPresence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).

Secondary

MeasureTime frameDescription
Number of Emesis Episodes in the Intraoperative Period PeriodIntraoperative periodThe number of emesis episodes during the cesarean section intraoperative period.
Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and VomitingIntraoperative periodReported 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.

Other

MeasureTime frameDescription
Number of Participants With Nausea96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. Have you experienced nausea?
Patient Questionnaire: Describe the Pattern of Your Nausea?96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea)Describe the pattern of your nausea (2 choices).
Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?96 HoursPatient 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.
Patient Questionnaire: Duration of Nausea.96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How many hours did the nausea last.
Patient Questionnaire: Severity of Nausea.96 HoursPatient 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).
Patient Questionnaire: Do You Think the Magnet Improves Nausea?96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve nausea response yes or no.
Patient Questionnaire: Do You Think the Magnet Improves Vomiting?96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve vomiting response yes or no.
The Number of Emesis From Post Anesthesia Care Unit to Discharge.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.
Intraoperative Lowest BP (mmHg)Intraoperative periodLowest systolic and diastolic blood pressure during the intraoperative period.
Intraoperative Total Vasopressor (VPE) [1]Intraoperative periodMeasure Description: Total vasopressor units expressed as phenylephrine units using an 80:1 ratio for ephedrine in micrograms.
Intraoperative Hypotension Episodes (n)IntraoperativeNumber of hypotension episodes experienced during the intraoperative period.
Intraoperative Crystalloid Co-load (mL)Intraoperative periodAmount of crystalloid fluids given as a co-load in milliliters during the intraoperative period.
Intraoperative Fluids Administered (mL)IntraoperativeTotal number of milliliters of fluids administered during the intraoperative period.
Duration of Intraoperative Anesthesia (Min)Intraoperative periodDuration of administration of intraoperative anesthesia in minutes.
Patient Questionnaire: Are You Satisfied With Acupressure?96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. Are you satisfied with acupressure response yes or no.
Antiemetic Medication Administered From the PACU Through Discharge96 hoursThe number(count) of antiemetic medication administered per group in the post anesthesia care unit through discharge from the hospital
Patient Questionnaire: Have You Experienced Dry Retching or Vomiting96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. Have you experienced dry retching or vomiting?
Patient Questionnaire: Number of Times Vomited96 HoursPatient recovery questionnaire administered prior to discharge from the hospital. (of those who indicated vomiting) How many times did you vomit.

Countries

United States

Participant flow

Recruitment details

200 consented 1 dropped out in the P6 treatment group.

Participants by arm

ArmCount
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.
100
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.
99
Total199

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicSham Pressure PointP6 Accupressure GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
100 Participants99 Participants199 Participants
Age, Continuous34.6 Years
STANDARD_DEVIATION 4.5
35.3 Years
STANDARD_DEVIATION 4.8
35 Years
STANDARD_DEVIATION 4.7
American Society of Anesthesiology (ASA) physical status n
ASA 2
74 Participants81 Participants155 Participants
American Society of Anesthesiology (ASA) physical status n
ASA 3
26 Participants18 Participants44 Participants
Body Mass Index (kg/m^2)31.6 kg/m^231.4 kg/m^231.5 kg/m^2
Ethnicity (NIH/OMB)
Hispanic or Latino
26 Participants20 Participants46 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
74 Participants79 Participants153 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Height (cm)163 centimeters
STANDARD_DEVIATION 7.5
164 centimeters
STANDARD_DEVIATION 7.5
163 centimeters
STANDARD_DEVIATION 7.5
History of nausea/vomiting
No
55 Participants50 Participants105 Participants
History of nausea/vomiting
Yes
45 Participants49 Participants94 Participants
Initial BP in operating room (mmHg)
Diastolic
82 mmHg79 mmHg80 mmHg
Initial BP in operating room (mmHg)
Systolic
136 mmHg134 mmHg135 mmHg
Parity
0
15 Participants27 Participants42 Participants
Parity
1
55 Participants46 Participants101 Participants
Parity
2
23 Participants18 Participants41 Participants
Parity
3
7 Participants8 Participants15 Participants
Prior cesarean delivery (n)
No prior cesarean delivery
25 Participants31 Participants56 Participants
Prior cesarean delivery (n)
Yes, previous cesarean delivery
75 Participants68 Participants143 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
8 Participants5 Participants13 Participants
Race (NIH/OMB)
Black or African American
10 Participants16 Participants26 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
79 Participants76 Participants155 Participants
Region of Enrollment
United States
100 participants99 participants199 participants
Sex: Female, Male
Female
100 Participants99 Participants199 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Type of neuraxial anesthesia
Combined spinal epidural
7 Participants13 Participants20 Participants
Type of neuraxial anesthesia
Spinal
93 Participants86 Participants179 Participants
Weight (kg)86 Kilograms
STANDARD_DEVIATION 19
89 Kilograms
STANDARD_DEVIATION 18
87 Kilograms
STANDARD_DEVIATION 18

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 99
other
Total, other adverse events
57 / 10056 / 99
serious
Total, serious adverse events
0 / 1000 / 99

Outcome results

Primary

Presence of Intraoperative Nausea

Presence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).

Time frame: Intraoperative period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPresence of Intraoperative Nausea57 Participants
P6 Accupressure GroupPresence of Intraoperative Nausea56 Participants
Comparison: The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100p-value: 0.95Chi-squared
Primary

Presence of Intraoperative Vomiting

Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).

Time frame: Intraoperative Period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPresence of Intraoperative Vomiting17 Participants
P6 Accupressure GroupPresence of Intraoperative Vomiting17 Participants
Comparison: The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).p-value: 0.94Chi-squared
Secondary

Number of Emesis Episodes in the Intraoperative Period Period

The number of emesis episodes during the cesarean section intraoperative period.

Time frame: Intraoperative period

Population: Reported number of emesis episodes based on number of subjects who experienced emesis .~17 in sham group and 17 in the P6 acupressure group.

ArmMeasureValue (MEDIAN)
Sham Pressure PointNumber of Emesis Episodes in the Intraoperative Period Period2 Emesis episodes
P6 Accupressure GroupNumber of Emesis Episodes in the Intraoperative Period Period2 Emesis episodes
Secondary

Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting

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.

Time frame: Intraoperative period

Population: Number of antiemetic and/or anti-nausea medications administered in the intraoperative period.

ArmMeasureValue (NUMBER)
Sham Pressure PointNumber of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting10 Number of antiemetics per group
P6 Accupressure GroupNumber of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting10 Number of antiemetics per group
Other Pre-specified

Antiemetic Medication Administered From the PACU Through Discharge

The number(count) of antiemetic medication administered per group in the post anesthesia care unit through discharge from the hospital

Time frame: 96 hours

ArmMeasureValue (NUMBER)
Sham Pressure PointAntiemetic Medication Administered From the PACU Through Discharge27 Doses administered
P6 Accupressure GroupAntiemetic Medication Administered From the PACU Through Discharge30 Doses administered
Other Pre-specified

Duration of Intraoperative Anesthesia (Min)

Duration of administration of intraoperative anesthesia in minutes.

Time frame: Intraoperative period

ArmMeasureValue (MEDIAN)
Sham Pressure PointDuration of Intraoperative Anesthesia (Min)81 Minutes
P6 Accupressure GroupDuration of Intraoperative Anesthesia (Min)81 Minutes
Other Pre-specified

Intraoperative Crystalloid Co-load (mL)

Amount of crystalloid fluids given as a co-load in milliliters during the intraoperative period.

Time frame: Intraoperative period

ArmMeasureValue (MEDIAN)
Sham Pressure PointIntraoperative Crystalloid Co-load (mL)500 Milliliters
P6 Accupressure GroupIntraoperative Crystalloid Co-load (mL)500 Milliliters
Other Pre-specified

Intraoperative Fluids Administered (mL)

Total number of milliliters of fluids administered during the intraoperative period.

Time frame: Intraoperative

ArmMeasureValue (MEDIAN)
Sham Pressure PointIntraoperative Fluids Administered (mL)2000 Milliliters
P6 Accupressure GroupIntraoperative Fluids Administered (mL)1800 Milliliters
Other Pre-specified

Intraoperative Hypotension Episodes (n)

Number of hypotension episodes experienced during the intraoperative period.

Time frame: Intraoperative

ArmMeasureValue (MEDIAN)
Sham Pressure PointIntraoperative Hypotension Episodes (n)1 Hypotension episodes
P6 Accupressure GroupIntraoperative Hypotension Episodes (n)1 Hypotension episodes
Other Pre-specified

Intraoperative Lowest BP (mmHg)

Lowest systolic and diastolic blood pressure during the intraoperative period.

Time frame: Intraoperative period

ArmMeasureGroupValue (MEAN)
Sham Pressure PointIntraoperative Lowest BP (mmHg)Systolic Blood Pressure116 mm/Hg
Sham Pressure PointIntraoperative Lowest BP (mmHg)Diastolic Blood Pressure61 mm/Hg
P6 Accupressure GroupIntraoperative Lowest BP (mmHg)Systolic Blood Pressure111 mm/Hg
P6 Accupressure GroupIntraoperative Lowest BP (mmHg)Diastolic Blood Pressure60 mm/Hg
Other Pre-specified

Intraoperative Total Vasopressor (VPE) [1]

Measure Description: Total vasopressor units expressed as phenylephrine units using an 80:1 ratio for ephedrine in micrograms.

Time frame: Intraoperative period

ArmMeasureValue (MEDIAN)
Sham Pressure PointIntraoperative Total Vasopressor (VPE) [1]2052 micrograms
P6 Accupressure GroupIntraoperative Total Vasopressor (VPE) [1]2190 micrograms
Other Pre-specified

Number of Participants With Nausea

Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced nausea?

Time frame: 96 Hours

Population: 73 in the sham group and 74 in the P6 group completed the survey question

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointNumber of Participants With Nausea51 Participants
P6 Accupressure GroupNumber of Participants With Nausea53 Participants
Other Pre-specified

Patient Questionnaire: Are You Satisfied With Acupressure?

Patient recovery questionnaire administered prior to discharge from the hospital. Are you satisfied with acupressure response yes or no.

Time frame: 96 Hours

Population: 61 in the sham group and 65 in the P6 group completed the survey question.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Are You Satisfied With Acupressure?Satisfied with acupressure (yes)29 Participants
Sham Pressure PointPatient Questionnaire: Are You Satisfied With Acupressure?Not satisfied with acupressure (no)32 Participants
P6 Accupressure GroupPatient Questionnaire: Are You Satisfied With Acupressure?Satisfied with acupressure (yes)33 Participants
P6 Accupressure GroupPatient Questionnaire: Are You Satisfied With Acupressure?Not satisfied with acupressure (no)32 Participants
Other Pre-specified

Patient Questionnaire: Describe the Pattern of Your Nausea?

Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea)Describe the pattern of your nausea (2 choices).

Time frame: 96 Hours

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Describe the Pattern of Your Nausea?Nausea comes and goes40 Participants
Sham Pressure PointPatient Questionnaire: Describe the Pattern of Your Nausea?Nausea is constant5 Participants
Sham Pressure PointPatient Questionnaire: Describe the Pattern of Your Nausea?No response6 Participants
P6 Accupressure GroupPatient Questionnaire: Describe the Pattern of Your Nausea?Nausea comes and goes44 Participants
P6 Accupressure GroupPatient Questionnaire: Describe the Pattern of Your Nausea?Nausea is constant2 Participants
P6 Accupressure GroupPatient Questionnaire: Describe the Pattern of Your Nausea?No response7 Participants
Other Pre-specified

Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?

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.

Time frame: 96 Hours

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?A little interference11 Participants
Sham Pressure PointPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?Most of the time3 Participants
Sham Pressure PointPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?Some of the time1 Participants
Sham Pressure PointPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?No response0 Participants
Sham Pressure PointPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?No interference36 Participants
P6 Accupressure GroupPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?No response2 Participants
P6 Accupressure GroupPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?No interference34 Participants
P6 Accupressure GroupPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?A little interference11 Participants
P6 Accupressure GroupPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?Some of the time2 Participants
P6 Accupressure GroupPatient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?Most of the time4 Participants
Other Pre-specified

Patient Questionnaire: Do You Think the Magnet Improves Nausea?

Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve nausea response yes or no.

Time frame: 96 Hours

Population: Please note 62 in the sham group and 64 in the P6 group completed this survey question.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Do You Think the Magnet Improves Nausea?Improves nausea (yes)23 Participants
Sham Pressure PointPatient Questionnaire: Do You Think the Magnet Improves Nausea?Does not improve nausea (no)39 Participants
P6 Accupressure GroupPatient Questionnaire: Do You Think the Magnet Improves Nausea?Improves nausea (yes)25 Participants
P6 Accupressure GroupPatient Questionnaire: Do You Think the Magnet Improves Nausea?Does not improve nausea (no)39 Participants
Other Pre-specified

Patient Questionnaire: Do You Think the Magnet Improves Vomiting?

Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve vomiting response yes or no.

Time frame: 96 Hours

Population: Please not that 60 in the sham group and 62 in the P6 group completed the survey question.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Do You Think the Magnet Improves Vomiting?Improves vomiting (yes)15 Participants
Sham Pressure PointPatient Questionnaire: Do You Think the Magnet Improves Vomiting?Does not improve vomiting (no)45 Participants
P6 Accupressure GroupPatient Questionnaire: Do You Think the Magnet Improves Vomiting?Improves vomiting (yes)19 Participants
P6 Accupressure GroupPatient Questionnaire: Do You Think the Magnet Improves Vomiting?Does not improve vomiting (no)43 Participants
Other Pre-specified

Patient Questionnaire: Duration of Nausea.

Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How many hours did the nausea last.

Time frame: 96 Hours

Population: 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.

ArmMeasureValue (MEDIAN)
Sham Pressure PointPatient Questionnaire: Duration of Nausea.2 Hours
P6 Accupressure GroupPatient Questionnaire: Duration of Nausea.4 Hours
Other Pre-specified

Patient Questionnaire: Have You Experienced Dry Retching or Vomiting

Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced dry retching or vomiting?

Time frame: 96 Hours

Population: 73 in the sham group and 74 in the P6 group completed the survey question

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Sham Pressure PointPatient Questionnaire: Have You Experienced Dry Retching or VomitingHas experienced dry retching3 Participants
Sham Pressure PointPatient Questionnaire: Have You Experienced Dry Retching or VomitingHas experienced vomiting20 Participants
P6 Accupressure GroupPatient Questionnaire: Have You Experienced Dry Retching or VomitingHas experienced dry retching10 Participants
P6 Accupressure GroupPatient Questionnaire: Have You Experienced Dry Retching or VomitingHas experienced vomiting20 Participants
Other Pre-specified

Patient Questionnaire: Number of Times Vomited

Patient recovery questionnaire administered prior to discharge from the hospital. (of those who indicated vomiting) How many times did you vomit.

Time frame: 96 Hours

Population: 73 in the sham group and 74 in the P6 group completed the survey question

ArmMeasureValue (MEDIAN)
Sham Pressure PointPatient Questionnaire: Number of Times Vomited2 Vomit episodes
P6 Accupressure GroupPatient Questionnaire: Number of Times Vomited2 Vomit episodes
Other Pre-specified

Patient Questionnaire: Severity of 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).

Time frame: 96 Hours

Population: 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.

ArmMeasureGroupValue (MEDIAN)
Sham Pressure PointPatient Questionnaire: Severity of Nausea.Highest level of nausea50 score on a scale (0 good-100 severe)
Sham Pressure PointPatient Questionnaire: Severity of Nausea.Lowest level of nausea4 score on a scale (0 good-100 severe)
P6 Accupressure GroupPatient Questionnaire: Severity of Nausea.Highest level of nausea63 score on a scale (0 good-100 severe)
P6 Accupressure GroupPatient Questionnaire: Severity of Nausea.Lowest level of nausea4 score on a scale (0 good-100 severe)
Other Pre-specified

The Number of Emesis From Post Anesthesia Care Unit to Discharge.

Reported 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.

Time frame: 96 hours

ArmMeasureValue (NUMBER)
Sham Pressure PointThe Number of Emesis From Post Anesthesia Care Unit to Discharge.17 Emesis episodes
P6 Accupressure GroupThe Number of Emesis From Post Anesthesia Care Unit to Discharge.13 Emesis episodes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026