Knee Arthropathy, Hip Arthropathy, Anxiety
Conditions
Keywords
Acupuncture, Total Knee Arthroplasty, Total hip arthroplasty, Anxiety, Pain
Brief summary
Open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety, reduce postoperative pain, reduce postoperative nausea and vomiting, reduce opioid consumption, and improve patient satisfaction.
Detailed description
Acupuncture has been extensively practiced and studied worldwide, particularly as a part of Eastern medicine, but it is a relatively uncommon therapy offered in Western medical institutions, such as those in the United States. Considering the commonly cited benefits of acupuncture, such as reduced anxiety and pain, hospitals throughout the United States have the opportunity to implement acupuncture as a cost-effective and safe technique for improving surgical outcomes. Acupuncture administered in the preoperative period can be particularly effective for reducing preoperative anxiety, postoperative pain, postoperative opioid consumption, and postoperative nausea and vomiting. Consequently, preoperative acupuncture can improve patient satisfaction and decrease hospital costs. However, due to a lack of implementation and experience, further research is needed to establish the safety and efficacy of preoperative acupuncture in United States medical practices. At the Bone-and-Joint Institute at Hartford Hospital, where this study is proposed, a quality study on total knee or hip arthroplasty patients found that 21% of its monthly patients were high-anxiety according to the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Thus, there is a significant population of patients who would benefit from a procedure to reduce preoperative anxiety at our facility. This proposal is for a prospective, open-label, randomized controlled trial to determine the effect of preoperative acupuncture on preoperative anxiety and postoperative pain for high-anxiety patients undergoing total hip or knee arthroplasty. The hypothesis is that preoperative acupuncture will reduce preoperative anxiety and postoperative pain as well as reduce postoperative nausea and vomiting and opioid consumption and improve patient satisfaction. The study population is to include adult patients undergoing lower extremity total joint arthroplasty, including hip and knee joints, at the Bone-and-Joint Institute at Hartford Hospital.
Interventions
DEVICEAcupuncture needles
The acupuncture intervention includes a combination of auricular and body acupuncture. The auricular points used are Shen men, Zero point, Tranquilizer point, and Master cerebral. The body points used are the wrist PC6.
Sponsors
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-center, prospective, unblinded, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Female (age 52 to 85) or male (age 18-85) patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty at the Bone-and Joint Institute at Hartford Hospital * Patients classified as high-anxiety based on having a score of \>10 on the Amsterdam Preoperative Anxiety and Information Scale (APAIS-A-T). The APAIS-A-T is a modified survey that reliably quantifies total preoperative anxiety using summed scores for anesthesia and surgery-related anxiety; a minimum score of 11 is the most accurate cutoff to identify patients with anxiety
Exclusion criteria
* Unable to give consent * Uncontrolled diabetes (HbA1c ≥ 8.0%) * Infection at any of the acupuncture points * Known allergy to metals * Abnormal laboratory blood work values (INR\>1.5, if available; platelet count \<70,000, if available) * Patients with active ongoing coagulopathy based on lab data (INR \>1.5) and/or on current anticoagulant use which increases bleeding risk. * Non-English speaking * Revision TKA or THA * Women of reproductive age or under the age of 52 years old, as acupuncture is not recommended during pregnancy. They were excluded due to the potential conflict between our institute's standard timing for pregnancy tests on the day of surgery and the scheduled preoperative acupuncture session for the study, to avoid unwanted delays in the operating room schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Anxiety | Prior to acupuncture and 30 minutes after acupuncture | Determine the effect of preoperative acupuncture on preoperative anxiety in the acupuncture group using VAS (Visual Analog Scale) which is a 10 centimeters line in length, from 0-100, with 0 at the left extreme being not at all anxious and 100 at the right extreme being very anxious. Participants put a cross on the line to indicate how they felt at the time point used. A higher score means worse as it means high anxiety. |
| Postoperative Pain in the First 3 Postoperative Hours | Total mean pain in the first 3 postoperative hours | Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean of the total pain in the first 3 postoperative hours between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | During hospitalization, up to 24 hours post surgery | Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery. |
| Midazolam Use as Anxiolytic Medications | During hospitalization, up to 24 hours post surgery | The dose of Midazolam as an anxiolytic medication that was given at any time throughout hospitalization up to 24 postoperative hours. |
| Patient Satisfaction Scale With Overall Care | Within 1 week after hospital discharge | Patients' satisfaction with overall care management was compared using the patient satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied with overall care. Each frequency represents the percentage of patients in each group who have been either satisfied or extremely satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call. |
| Occurrence of Nausea and Vomiting at First Postoperative Hour | At 1 postoperative hour | Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with yes defined as any number above 0 in the scale, while no defined as 0. |
| Antiemetic Medications | During hospitalization, up to 24 hours post surgery | The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours |
| Hospital Length of Stay | From the date and time of admission to the date and time of discharge, assessed as 24-48 hours | Using the hospital admission and discharge dates & times; this will be compared between the two groups. |
| Postoperative Pain Upon Arrival to the PACU | Postoperative pain at time of PACU arrival | Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean pain scores between groups upon arrival to the PACU. |
| Patient Satisfaction With Acupuncture Procedure | Within 1 week after hospital discharge | Patients' satisfaction with acupuncture intervention was assessed in the acupuncture group only using the satisfaction scale of (1-5), where 1 is Extremely satisfied, 2 is Very satisfied, 3 is Somewhat satisfied, 4 is Not very satisfied, and 5 is Not at all satisfied. Each frequency represented the percentage of patients who were satisfied (given a score of 1 or 2 out of 5) with their acupuncture treatment. This assessment was done within a week after discharge, via a phone call. |
| Postoperative Pain After 3 Postoperative Hours | After three postoperative hours | Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean pain scores after three postoperative hours between groups. |
| Number of Participants That Received Midazolam Dose >2mg | During hospitalization up to 24 postoperative hours | The number of participants who received a dose of midazolam exceeding 2 mg indicated a high level of perioperative anxiety that necessitated pharmacological intervention. The decision to use a dose higher than 2 mg was based on the standard practice of administering 2 mg of midazolam for preoperative regional nerve blocks; any dosage surpassing this amount was specifically intended for anxiety management. |
| Patient's Satisfaction With Pain Management | Within 1 week after hospital discharge | Patients' satisfaction with their postoperative pain management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10)This assessment was done within a week after discharge, via a phone call. |
| Patient's Satisfaction With Anxiety Management | Within 1 week after hospital discharge | Patients' satisfaction with their perioperative anxiety management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call. |
| Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries | Within 1 week after hospital discharge | Patients with acupuncture intervention were assessed for how likely to consider acupuncture for future surgeries using a scale of (1-4), where 1 is Very likely, 2 is Likely, 3 is Maybe, and 4 is Never. Each frequency represented the percentage of patients who were more likely (given a score of 1 or 2 out of 4) to receive acupuncture treatment in a future surgery. This assessment was done within a week after discharge, via a phone call. |
| Occurrence of Nausea and Vomiting After 3 Postoperative Hours | After 3 postoperative hours | Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with yes defined as any number above 0 in the scale, while no defined as 0. |
| Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour | Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. To compare mean pain scores between groups, considering all 3 individual time points (at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour) |
| Postoperative Pain at 1 Postoperative Hour | At the first postoperative hour | Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean of pain scores at the first postoperative hour between groups. |
| Preoperative Pain | Prior to acupuncture and 30 minutes after acupuncture | Determine the effect of preoperative acupuncture on preoperative pain in the acupuncture group using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare pre-acupuncture pain to post-acupuncture pain score in the acupuncture group only. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on their high anxiety score (according to the validated Amsterdam Preoperative Anxiety and Information Scale (APAIS-A-T\>10) who are scheduled for elective total knee or hip arthroplasty surgery at Bone and Joint Center from March 2022 to April 2023. The first patient was enrolled in March 21, 2022 and the last patient was enrolled in April 3, 2023.
Pre-assignment details
Of 123 screened patients, 60 met the inclusion criteria and were randomized to treatment. 31 patients declined participation, 26 patients did not meet the eligibility criteria, 5 patients consented but had surgery cancellation, and 1 patient withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Preoperative acupuncture
Acupuncture needles: The acupuncture intervention includes a combination of auricular and body acupuncture. The auricular points used are Shen men, Zero point, Tranquilizer point, and Master cerebral.
The body points used are the wrist PC6. | 30 |
| Control No acupuncture | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Preoperative surveys missed | 0 | 1 |
Baseline characteristics
| Characteristic | Acupuncture | Control | Total |
|---|---|---|---|
| Age, Continuous | 69.60 Years STANDARD_DEVIATION 9.71 | 67.63 Years STANDARD_DEVIATION 7.71 | 68.62 Years STANDARD_DEVIATION 8.75 |
| Body Mass Index (BMI) | 32.16 kg/m2 STANDARD_DEVIATION 5.31 | 30.44 kg/m2 STANDARD_DEVIATION 5.51 | 31.30 kg/m2 STANDARD_DEVIATION 5.44 |
| Charlson Comorbidity Index (CCI) | 1.0 units on a scale | 0.0 units on a scale | 0.0 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 29 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of acupuncture No | 18 Participants | 23 Participants | 41 Participants |
| History of acupuncture Yes | 12 Participants | 7 Participants | 19 Participants |
| History of mental illness Anxiety | 13 Participants | 10 Participants | 23 Participants |
| History of mental illness Bipolar disorder | 0 Participants | 1 Participants | 1 Participants |
| History of mental illness Depression | 8 Participants | 6 Participants | 14 Participants |
| History of mental illness History of mental illnesses | 15 Participants | 12 Participants | 27 Participants |
| Modified Amsterdam Pre-operative Anxiety and Information Scale (APAIS) Score | 13.27 units on a scale STANDARD_DEVIATION 2.39 | 13.90 units on a scale STANDARD_DEVIATION 2.56 | 13.58 units on a scale STANDARD_DEVIATION 2.48 |
| Preoperative Visual Analogue Scale Score | 60.73 units on a scale STANDARD_DEVIATION 21.28 | 59.66 units on a scale STANDARD_DEVIATION 30.11 | 60.20 units on a scale STANDARD_DEVIATION 25.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 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 | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
| Surgery type Total Hip Arthroplasty | 15 Participants | 16 Participants | 31 Participants |
| Surgery type Total Knee Arthroplasty | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 13 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Perioperative Anxiety
Determine the effect of preoperative acupuncture on preoperative anxiety in the acupuncture group using VAS (Visual Analog Scale) which is a 10 centimeters line in length, from 0-100, with 0 at the left extreme being not at all anxious and 100 at the right extreme being very anxious. Participants put a cross on the line to indicate how they felt at the time point used. A higher score means worse as it means high anxiety.
Time frame: Prior to acupuncture and 30 minutes after acupuncture
Population: Only participants in the acupuncture group (n=30) completed the Visual Analog Scale to reflect the level of anxiety they had before and 30 minutes after receiving the acupuncture procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Perioperative Anxiety | 60.73 score on a scale | Standard Deviation 21.28 |
| Preoperative Post-acupuncture | Perioperative Anxiety | 28.90 score on a scale | Standard Deviation 21.54 |
p-value: <0.001t-test, 2 sided
Primary
Postoperative Pain in the First 3 Postoperative Hours
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean of the total pain in the first 3 postoperative hours between groups.
Time frame: Total mean pain in the first 3 postoperative hours
Population: Total mean pain in the first 3 postoperative hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Postoperative Pain in the First 3 Postoperative Hours | 1.93 score on a scale | Standard Deviation 1.63 |
| Preoperative Post-acupuncture | Postoperative Pain in the First 3 Postoperative Hours | 2.79 score on a scale | Standard Deviation 2.83 |
p-value: 0.029t-test, 2 sided
Secondary
Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries
Patients with acupuncture intervention were assessed for how likely to consider acupuncture for future surgeries using a scale of (1-4), where 1 is Very likely, 2 is Likely, 3 is Maybe, and 4 is Never. Each frequency represented the percentage of patients who were more likely (given a score of 1 or 2 out of 4) to receive acupuncture treatment in a future surgery. This assessment was done within a week after discharge, via a phone call.
Time frame: Within 1 week after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Acupuncture Patients Who Were Likely to Consider Acupuncture for Future Surgeries | 25 Participants |
Secondary
Antiemetic Medications
The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours
Time frame: During hospitalization, up to 24 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Pre-acupuncture | Antiemetic Medications | 0.0 number of doses |
| Preoperative Post-acupuncture | Antiemetic Medications | 0.0 number of doses |
p-value: 0.37Wilcoxon (Mann-Whitney)
Secondary
Hospital Length of Stay
Using the hospital admission and discharge dates & times; this will be compared between the two groups.
Time frame: From the date and time of admission to the date and time of discharge, assessed as 24-48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Pre-acupuncture | Hospital Length of Stay | 29.5 hours |
| Preoperative Post-acupuncture | Hospital Length of Stay | 29.0 hours |
p-value: 0.38Wilcoxon (Mann-Whitney)
Secondary
Midazolam Use as Anxiolytic Medications
The dose of Midazolam as an anxiolytic medication that was given at any time throughout hospitalization up to 24 postoperative hours.
Time frame: During hospitalization, up to 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Midazolam Use as Anxiolytic Medications | 3.96 milligrams | Standard Deviation 1.73 |
| Preoperative Post-acupuncture | Midazolam Use as Anxiolytic Medications | 4.21 milligrams | Standard Deviation 1.8 |
p-value: 0.61t-test, 2 sided
Secondary
Number of Participants That Received Midazolam Dose >2mg
The number of participants who received a dose of midazolam exceeding 2 mg indicated a high level of perioperative anxiety that necessitated pharmacological intervention. The decision to use a dose higher than 2 mg was based on the standard practice of administering 2 mg of midazolam for preoperative regional nerve blocks; any dosage surpassing this amount was specifically intended for anxiety management.
Time frame: During hospitalization up to 24 postoperative hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Number of Participants That Received Midazolam Dose >2mg | 19 Participants |
| Preoperative Post-acupuncture | Number of Participants That Received Midazolam Dose >2mg | 22 Participants |
p-value: 0.41Chi-squared
Secondary
Occurrence of Nausea and Vomiting After 3 Postoperative Hours
Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with yes defined as any number above 0 in the scale, while no defined as 0.
Time frame: After 3 postoperative hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preoperative Pre-acupuncture | Occurrence of Nausea and Vomiting After 3 Postoperative Hours | Yes | 5 Participants |
| Preoperative Pre-acupuncture | Occurrence of Nausea and Vomiting After 3 Postoperative Hours | No | 25 Participants |
| Preoperative Post-acupuncture | Occurrence of Nausea and Vomiting After 3 Postoperative Hours | Yes | 5 Participants |
| Preoperative Post-acupuncture | Occurrence of Nausea and Vomiting After 3 Postoperative Hours | No | 25 Participants |
p-value: 1Chi-squared
Secondary
Occurrence of Nausea and Vomiting at First Postoperative Hour
Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale was used to report the occurrence of nausea (yes/no), with yes defined as any number above 0 in the scale, while no defined as 0.
Time frame: At 1 postoperative hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preoperative Pre-acupuncture | Occurrence of Nausea and Vomiting at First Postoperative Hour | Yes | 0 Participants |
| Preoperative Pre-acupuncture | Occurrence of Nausea and Vomiting at First Postoperative Hour | No | 30 Participants |
| Preoperative Post-acupuncture | Occurrence of Nausea and Vomiting at First Postoperative Hour | Yes | 4 Participants |
| Preoperative Post-acupuncture | Occurrence of Nausea and Vomiting at First Postoperative Hour | No | 26 Participants |
p-value: 0.11Fisher Exact
Secondary
Opioid Consumption
Postoperative opioid consumption to be converted into morphine milliequivalents (MMEs) and compared between the two groups for up to 24 hours post surgery.
Time frame: During hospitalization, up to 24 hours post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Opioid Consumption | 45.51 Morphine MilliEquivalent | Standard Deviation 30.02 |
| Preoperative Post-acupuncture | Opioid Consumption | 52.46 Morphine MilliEquivalent | Standard Deviation 30.92 |
p-value: 0.38t-test, 2 sided
Secondary
Patient Satisfaction Scale With Overall Care
Patients' satisfaction with overall care management was compared using the patient satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied with overall care. Each frequency represents the percentage of patients in each group who have been either satisfied or extremely satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.
Time frame: Within 1 week after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Patient Satisfaction Scale With Overall Care | 21 Participants |
| Preoperative Post-acupuncture | Patient Satisfaction Scale With Overall Care | 24 Participants |
p-value: 0.37Chi-squared
Secondary
Patient Satisfaction With Acupuncture Procedure
Patients' satisfaction with acupuncture intervention was assessed in the acupuncture group only using the satisfaction scale of (1-5), where 1 is Extremely satisfied, 2 is Very satisfied, 3 is Somewhat satisfied, 4 is Not very satisfied, and 5 is Not at all satisfied. Each frequency represented the percentage of patients who were satisfied (given a score of 1 or 2 out of 5) with their acupuncture treatment. This assessment was done within a week after discharge, via a phone call.
Time frame: Within 1 week after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Patient Satisfaction With Acupuncture Procedure | 22 Participants |
Secondary
Patient's Satisfaction With Anxiety Management
Patients' satisfaction with their perioperative anxiety management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10). This assessment was done within a week after discharge, via a phone call.
Time frame: Within 1 week after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Patient's Satisfaction With Anxiety Management | 21 Participants |
| Preoperative Post-acupuncture | Patient's Satisfaction With Anxiety Management | 19 Participants |
p-value: 0.58Chi-squared
Secondary
Patient's Satisfaction With Pain Management
Patients' satisfaction with their postoperative pain management was compared between groups using the satisfaction scale of (1-10), where 1 is extremely unsatisfied and 10 is extremely satisfied. Each frequency represented the percentage of patients in each group who were satisfied (given a score of 9 or 10 out of 10)This assessment was done within a week after discharge, via a phone call.
Time frame: Within 1 week after hospital discharge
Population: Each frequency represented the percentage of patients in the group who were satisfied (given a score of 9 or 10 out of 10)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pre-acupuncture | Patient's Satisfaction With Pain Management | 19 Participants |
| Preoperative Post-acupuncture | Patient's Satisfaction With Pain Management | 20 Participants |
p-value: 0.79Chi-squared
Secondary
Postoperative Pain After 3 Postoperative Hours
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean pain scores after three postoperative hours between groups.
Time frame: After three postoperative hours
Population: Using the mean pain scores after three postoperative hours between groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Postoperative Pain After 3 Postoperative Hours | 3.67 score on a scale | Standard Deviation 3.03 |
| Preoperative Post-acupuncture | Postoperative Pain After 3 Postoperative Hours | 4.55 score on a scale | Standard Deviation 3.29 |
p-value: 0.098t-test, 2 sided
Secondary
Postoperative Pain at 1 Postoperative Hour
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean of pain scores at the first postoperative hour between groups.
Time frame: At the first postoperative hour
Population: Using the mean of pain scores reported by participants at the first postoperative hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Postoperative Pain at 1 Postoperative Hour | 1.67 score on a scale | Standard Deviation 2.22 |
| Preoperative Post-acupuncture | Postoperative Pain at 1 Postoperative Hour | 2.45 score on a scale | Standard Deviation 3.15 |
p-value: 0.147t-test, 2 sided
Secondary
Postoperative Pain in the First 3 Postoperative Hours (Group X Time)
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. To compare mean pain scores between groups, considering all 3 individual time points (at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour)
Time frame: Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative Pre-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | at arrival to PACU | 0.47 score on a scale | Standard Deviation 1.36 |
| Preoperative Pre-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | 1hr post-operation | 1.67 score on a scale | Standard Deviation 2.22 |
| Preoperative Pre-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | 3hr post-operation | 3.67 score on a scale | Standard Deviation 3.03 |
| Preoperative Post-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | at arrival to PACU | 1.38 score on a scale | Standard Deviation 2.83 |
| Preoperative Post-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | 1hr post-operation | 2.45 score on a scale | Standard Deviation 3.15 |
| Preoperative Post-acupuncture | Postoperative Pain in the First 3 Postoperative Hours (Group X Time) | 3hr post-operation | 4.55 score on a scale | Standard Deviation 3.29 |
p-value: 0.919ANCOVA
Secondary
Postoperative Pain Upon Arrival to the PACU
Determine the effect of preoperative acupuncture on postoperative pain in both groups, using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare the mean pain scores between groups upon arrival to the PACU.
Time frame: Postoperative pain at time of PACU arrival
Population: Mean pain scores upon arrival to the PACU between the groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Postoperative Pain Upon Arrival to the PACU | 0.47 score on a scale | Standard Deviation 1.36 |
| Preoperative Post-acupuncture | Postoperative Pain Upon Arrival to the PACU | 1.38 score on a scale | Standard Deviation 2.83 |
p-value: 0.087t-test, 2 sided
Secondary
Preoperative Pain
Determine the effect of preoperative acupuncture on preoperative pain in the acupuncture group using the self-reported NPS (Numeric Pain Scale) which is a scale of 0-10 where 0 is no pain and 10 is severe pain. Using the mean pain score to compare pre-acupuncture pain to post-acupuncture pain score in the acupuncture group only.
Time frame: Prior to acupuncture and 30 minutes after acupuncture
Population: Only participants in the acupuncture group (n=30) completed the Numeric Pain Scale to reflect the level of pain they had before and 30 minutes after receiving the acupuncture procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Pre-acupuncture | Preoperative Pain | 4.97 score on a scale | Standard Deviation 3.01 |
| Preoperative Post-acupuncture | Preoperative Pain | 2.90 score on a scale | Standard Deviation 6.62 |
p-value: <0.001t-test, 2 sided