Cesarean Delivery, Nausea, Pregnancy Related, Vomiting
Conditions
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
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.
Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Presence of Intraoperative Vomiting | Intraoperative Period | Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period). |
| Presence of Intraoperative Nausea | Intraoperative period | Presence of intraoperative nausea during scheduled cesarean delivery (intraoperative period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emesis Episodes in the Intraoperative Period Period | Intraoperative period | The number of emesis episodes during the cesarean section intraoperative period. |
| Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nausea | 96 Hours | Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced nausea? |
| Patient Questionnaire: Describe the Pattern of Your Nausea? | 96 Hours | Patient 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 Hours | 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. |
| Patient Questionnaire: Duration of Nausea. | 96 Hours | Patient 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 Hours | 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). |
| Patient Questionnaire: Do You Think the Magnet Improves Nausea? | 96 Hours | Patient 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 Hours | Patient 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 hours | 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. |
| Intraoperative Lowest BP (mmHg) | Intraoperative period | Lowest systolic and diastolic blood pressure during the intraoperative period. |
| Intraoperative Total Vasopressor (VPE) [1] | Intraoperative period | Measure Description: Total vasopressor units expressed as phenylephrine units using an 80:1 ratio for ephedrine in micrograms. |
| Intraoperative Hypotension Episodes (n) | Intraoperative | Number of hypotension episodes experienced during the intraoperative period. |
| Intraoperative Crystalloid Co-load (mL) | Intraoperative period | Amount of crystalloid fluids given as a co-load in milliliters during the intraoperative period. |
| Intraoperative Fluids Administered (mL) | Intraoperative | Total number of milliliters of fluids administered during the intraoperative period. |
| Duration of Intraoperative Anesthesia (Min) | Intraoperative period | Duration of administration of intraoperative anesthesia in minutes. |
| Patient Questionnaire: Are You Satisfied With Acupressure? | 96 Hours | Patient 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 Discharge | 96 hours | The 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 Vomiting | 96 Hours | Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced dry retching or vomiting? |
| Patient Questionnaire: Number of Times Vomited | 96 Hours | Patient 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
| Arm | Count |
|---|---|
| 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 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sham Pressure Point | P6 Accupressure Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 99 Participants | 199 Participants |
| Age, Continuous | 34.6 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 Participants | 81 Participants | 155 Participants |
| American Society of Anesthesiology (ASA) physical status n ASA 3 | 26 Participants | 18 Participants | 44 Participants |
| Body Mass Index (kg/m^2) | 31.6 kg/m^2 | 31.4 kg/m^2 | 31.5 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 20 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 79 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 Participants | 50 Participants | 105 Participants |
| History of nausea/vomiting Yes | 45 Participants | 49 Participants | 94 Participants |
| Initial BP in operating room (mmHg) Diastolic | 82 mmHg | 79 mmHg | 80 mmHg |
| Initial BP in operating room (mmHg) Systolic | 136 mmHg | 134 mmHg | 135 mmHg |
| Parity 0 | 15 Participants | 27 Participants | 42 Participants |
| Parity 1 | 55 Participants | 46 Participants | 101 Participants |
| Parity 2 | 23 Participants | 18 Participants | 41 Participants |
| Parity 3 | 7 Participants | 8 Participants | 15 Participants |
| Prior cesarean delivery (n) No prior cesarean delivery | 25 Participants | 31 Participants | 56 Participants |
| Prior cesarean delivery (n) Yes, previous cesarean delivery | 75 Participants | 68 Participants | 143 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 16 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 79 Participants | 76 Participants | 155 Participants |
| Region of Enrollment United States | 100 participants | 99 participants | 199 participants |
| Sex: Female, Male Female | 100 Participants | 99 Participants | 199 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of neuraxial anesthesia Combined spinal epidural | 7 Participants | 13 Participants | 20 Participants |
| Type of neuraxial anesthesia Spinal | 93 Participants | 86 Participants | 179 Participants |
| Weight (kg) | 86 Kilograms STANDARD_DEVIATION 19 | 89 Kilograms STANDARD_DEVIATION 18 | 87 Kilograms STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 57 / 100 | 56 / 99 |
| serious Total, serious adverse events | 0 / 100 | 0 / 99 |
Outcome results
Presence of Intraoperative Nausea
Presence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).
Time frame: Intraoperative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham Pressure Point | Presence of Intraoperative Nausea | 57 Participants |
| P6 Accupressure Group | Presence of Intraoperative Nausea | 56 Participants |
Presence of Intraoperative Vomiting
Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).
Time frame: Intraoperative Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham Pressure Point | Presence of Intraoperative Vomiting | 17 Participants |
| P6 Accupressure Group | Presence of Intraoperative Vomiting | 17 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Number of Emesis Episodes in the Intraoperative Period Period | 2 Emesis episodes |
| P6 Accupressure Group | Number of Emesis Episodes in the Intraoperative Period Period | 2 Emesis episodes |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Pressure Point | Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting | 10 Number of antiemetics per group |
| P6 Accupressure Group | Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting | 10 Number of antiemetics per group |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Pressure Point | Antiemetic Medication Administered From the PACU Through Discharge | 27 Doses administered |
| P6 Accupressure Group | Antiemetic Medication Administered From the PACU Through Discharge | 30 Doses administered |
Duration of Intraoperative Anesthesia (Min)
Duration of administration of intraoperative anesthesia in minutes.
Time frame: Intraoperative period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Duration of Intraoperative Anesthesia (Min) | 81 Minutes |
| P6 Accupressure Group | Duration of Intraoperative Anesthesia (Min) | 81 Minutes |
Intraoperative Crystalloid Co-load (mL)
Amount of crystalloid fluids given as a co-load in milliliters during the intraoperative period.
Time frame: Intraoperative period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Intraoperative Crystalloid Co-load (mL) | 500 Milliliters |
| P6 Accupressure Group | Intraoperative Crystalloid Co-load (mL) | 500 Milliliters |
Intraoperative Fluids Administered (mL)
Total number of milliliters of fluids administered during the intraoperative period.
Time frame: Intraoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Intraoperative Fluids Administered (mL) | 2000 Milliliters |
| P6 Accupressure Group | Intraoperative Fluids Administered (mL) | 1800 Milliliters |
Intraoperative Hypotension Episodes (n)
Number of hypotension episodes experienced during the intraoperative period.
Time frame: Intraoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Intraoperative Hypotension Episodes (n) | 1 Hypotension episodes |
| P6 Accupressure Group | Intraoperative Hypotension Episodes (n) | 1 Hypotension episodes |
Intraoperative Lowest BP (mmHg)
Lowest systolic and diastolic blood pressure during the intraoperative period.
Time frame: Intraoperative period
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham Pressure Point | Intraoperative Lowest BP (mmHg) | Systolic Blood Pressure | 116 mm/Hg |
| Sham Pressure Point | Intraoperative Lowest BP (mmHg) | Diastolic Blood Pressure | 61 mm/Hg |
| P6 Accupressure Group | Intraoperative Lowest BP (mmHg) | Systolic Blood Pressure | 111 mm/Hg |
| P6 Accupressure Group | Intraoperative Lowest BP (mmHg) | Diastolic Blood Pressure | 60 mm/Hg |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Intraoperative Total Vasopressor (VPE) [1] | 2052 micrograms |
| P6 Accupressure Group | Intraoperative Total Vasopressor (VPE) [1] | 2190 micrograms |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham Pressure Point | Number of Participants With Nausea | 51 Participants |
| P6 Accupressure Group | Number of Participants With Nausea | 53 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Are You Satisfied With Acupressure? | Satisfied with acupressure (yes) | 29 Participants |
| Sham Pressure Point | Patient Questionnaire: Are You Satisfied With Acupressure? | Not satisfied with acupressure (no) | 32 Participants |
| P6 Accupressure Group | Patient Questionnaire: Are You Satisfied With Acupressure? | Satisfied with acupressure (yes) | 33 Participants |
| P6 Accupressure Group | Patient Questionnaire: Are You Satisfied With Acupressure? | Not satisfied with acupressure (no) | 32 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Describe the Pattern of Your Nausea? | Nausea comes and goes | 40 Participants |
| Sham Pressure Point | Patient Questionnaire: Describe the Pattern of Your Nausea? | Nausea is constant | 5 Participants |
| Sham Pressure Point | Patient Questionnaire: Describe the Pattern of Your Nausea? | No response | 6 Participants |
| P6 Accupressure Group | Patient Questionnaire: Describe the Pattern of Your Nausea? | Nausea comes and goes | 44 Participants |
| P6 Accupressure Group | Patient Questionnaire: Describe the Pattern of Your Nausea? | Nausea is constant | 2 Participants |
| P6 Accupressure Group | Patient Questionnaire: Describe the Pattern of Your Nausea? | No response | 7 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | A little interference | 11 Participants |
| Sham Pressure Point | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | Most of the time | 3 Participants |
| Sham Pressure Point | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | Some of the time | 1 Participants |
| Sham Pressure Point | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | No response | 0 Participants |
| Sham Pressure Point | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | No interference | 36 Participants |
| P6 Accupressure Group | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | No response | 2 Participants |
| P6 Accupressure Group | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | No interference | 34 Participants |
| P6 Accupressure Group | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | A little interference | 11 Participants |
| P6 Accupressure Group | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | Some of the time | 2 Participants |
| P6 Accupressure Group | Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself? | Most of the time | 4 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Do You Think the Magnet Improves Nausea? | Improves nausea (yes) | 23 Participants |
| Sham Pressure Point | Patient Questionnaire: Do You Think the Magnet Improves Nausea? | Does not improve nausea (no) | 39 Participants |
| P6 Accupressure Group | Patient Questionnaire: Do You Think the Magnet Improves Nausea? | Improves nausea (yes) | 25 Participants |
| P6 Accupressure Group | Patient Questionnaire: Do You Think the Magnet Improves Nausea? | Does not improve nausea (no) | 39 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Do You Think the Magnet Improves Vomiting? | Improves vomiting (yes) | 15 Participants |
| Sham Pressure Point | Patient Questionnaire: Do You Think the Magnet Improves Vomiting? | Does not improve vomiting (no) | 45 Participants |
| P6 Accupressure Group | Patient Questionnaire: Do You Think the Magnet Improves Vomiting? | Improves vomiting (yes) | 19 Participants |
| P6 Accupressure Group | Patient Questionnaire: Do You Think the Magnet Improves Vomiting? | Does not improve vomiting (no) | 43 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Duration of Nausea. | 2 Hours |
| P6 Accupressure Group | Patient Questionnaire: Duration of Nausea. | 4 Hours |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Have You Experienced Dry Retching or Vomiting | Has experienced dry retching | 3 Participants |
| Sham Pressure Point | Patient Questionnaire: Have You Experienced Dry Retching or Vomiting | Has experienced vomiting | 20 Participants |
| P6 Accupressure Group | Patient Questionnaire: Have You Experienced Dry Retching or Vomiting | Has experienced dry retching | 10 Participants |
| P6 Accupressure Group | Patient Questionnaire: Have You Experienced Dry Retching or Vomiting | Has experienced vomiting | 20 Participants |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Number of Times Vomited | 2 Vomit episodes |
| P6 Accupressure Group | Patient Questionnaire: Number of Times Vomited | 2 Vomit episodes |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sham Pressure Point | Patient Questionnaire: Severity of Nausea. | Highest level of nausea | 50 score on a scale (0 good-100 severe) |
| Sham Pressure Point | Patient Questionnaire: Severity of Nausea. | Lowest level of nausea | 4 score on a scale (0 good-100 severe) |
| P6 Accupressure Group | Patient Questionnaire: Severity of Nausea. | Highest level of nausea | 63 score on a scale (0 good-100 severe) |
| P6 Accupressure Group | Patient Questionnaire: Severity of Nausea. | Lowest level of nausea | 4 score on a scale (0 good-100 severe) |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Pressure Point | The Number of Emesis From Post Anesthesia Care Unit to Discharge. | 17 Emesis episodes |
| P6 Accupressure Group | The Number of Emesis From Post Anesthesia Care Unit to Discharge. | 13 Emesis episodes |