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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Preoperative acupuncture |
|
| Control | No Intervention | No acupuncture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture needles | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prior to acupuncture and 30 minutes after acupuncture |
| 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. | Total mean pain in the first 3 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women aged 52-85 were included. women under 52 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bone and Joint Institute- Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15851892 | Background | Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024. | |
| 24761180 | Background | Lu DP, Lu GP. An Historical Review and Perspective on the Impact of Acupuncture on U.S. Medicine and Society. Med Acupunct. 2013 Oct;25(5):311-316. doi: 10.1089/acu.2012.0921. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | No acupuncture |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Prior to acupuncture and 30 minutes after acupuncture |
|
Adverse events were collected up to 30 postoperative days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture Group | Patients who received the preoperative acupuncture procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local bleeding | Surgical and medical procedures | Systematic Assessment | Immediate complication of acupuncture which is a few drops of blood at the site of the acupuncture needle insertion |
The limitation of this study is the open-label aspect could be associated with placebo effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aseel Walker | Hartford Hospital | 860-972-1778 | aseel.walker@hhchealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 2, 2023 | Oct 19, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single-center, prospective, unblinded, randomized controlled clinical trial
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|
| Within 1 week after hospital discharge |
| 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. | Prior to acupuncture and 30 minutes after acupuncture |
| 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. | During hospitalization, up to 24 hours post surgery |
| 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. | During hospitalization, up to 24 hours post surgery |
| 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. | Within 1 week after hospital discharge |
| 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. | At 1 postoperative hour |
| Antiemetic Medications | The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours | During hospitalization, up to 24 hours post surgery |
| Hospital Length of Stay | Using the hospital admission and discharge dates & times; this will be compared between the two groups. | From the date and time of admission to the date and time of discharge, assessed as 24-48 hours |
| 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. | Postoperative pain at time of PACU arrival |
| 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. | At the first postoperative hour |
| 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. | After three postoperative hours |
| 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. | During hospitalization up to 24 postoperative hours |
| 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. | Within 1 week after hospital discharge |
| 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. | Within 1 week after hospital discharge |
| 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. | Within 1 week after hospital discharge |
| 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. | After 3 postoperative hours |
| 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) | Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour |
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| 17608061 | Background | Usichenko TI, Dinse M, Lysenyuk VP, Wendt M, Pavlovic D, Lehmann C. Auricular acupuncture reduces intraoperative fentanyl requirement during hip arthroplasty--a randomized double-blinded study. Acupunct Electrother Res. 2006;31(3-4):213-21. doi: 10.3727/036012906815844265. |
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| 27692782 | Background | Ali A, Lindstrand A, Sundberg M, Flivik G. Preoperative Anxiety and Depression Correlate With Dissatisfaction After Total Knee Arthroplasty: A Prospective Longitudinal Cohort Study of 186 Patients, With 4-Year Follow-Up. J Arthroplasty. 2017 Mar;32(3):767-770. doi: 10.1016/j.arth.2016.08.033. Epub 2016 Sep 3. |
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| 28736592 | Background | Furuse N, Shinbara H, Uehara A, Sugawara M, Yamazaki T, Hosaka M, Yamashita H. A Multicenter Prospective Survey of Adverse Events Associated with Acupuncture and Moxibustion in Japan. Med Acupunct. 2017 Jun 1;29(3):155-162. doi: 10.1089/acu.2017.1230. |
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| 25158837 | Result | Chen CC, Yang CC, Hu CC, Shih HN, Chang YH, Hsieh PH. Acupuncture for pain relief after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):31-6. doi: 10.1097/AAP.0000000000000138. |
| 17242083 | Result | Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd. |
| 39383026 | Derived | Kainkaryam P, Vincze S, Takata E, Secor E, Panza G, Walker A, Gallagher G, Bergner A, Finkel J, Kumar M, Witmer D, Shekhman M, Nagarkatti D. Open-Label Randomized Clinical Trial to Assess the Effects of Preoperative Acupuncture in High Anxiety Patients Undergoing Total Knee or Hip Arthroplasty. J Integr Complement Med. 2025 Feb;31(2):174-182. doi: 10.1089/jicm.2024.0314. Epub 2024 Oct 9. |
| Control |
No acupuncture |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Charlson Comorbidity Index (CCI) | Charlson Comorbidity Index is a morbidity score for mortality ris, it identifies 19 comorbidities and assigns weight to each, ranging from 1 to 6 points. The total score is the sum of points and ranges 0 (no disease burden) to 29 (maximal disease burden). Conditions are MI, CHF, PVD, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, ulcer disease, mild liver disease, diabetes, hemiplegia, moderate or several renal disease, diabetes with end organ damage, any tumor, leukemia, lymphoma, moderate or severe liver disease, metastatic solid tumor, AIDS. | Median | Inter-Quartile Range | units on a scale |
|
| History of mental illness | Count of Participants | Participants |
|
| History of acupuncture | Count of Participants | Participants |
|
| Modified Amsterdam Pre-operative Anxiety and Information Scale (APAIS) Score | The Modified Amsterdam Pre-operative Anxiety and Information Scale (APAIS-A-T) is a modified survey that quantifies preoperative anxiety using four instead of six questions about anesthesia- and surgery-related anxiety, with each question scoring from 1 (not at all) to 5 (extremely). Total score is the sum of the four questions which ranges from 4 to 20, a minimum score of 11 was used as the most accurate cutoff to identify patients with high anxiety in this study. | Mean | Standard Deviation | units on a scale |
|
| Preoperative Visual Analogue Scale Score | The Preoperative Visual Analogue Scale VAS is a unidimensional measure of anxiety. It is a straight horizontal line of 100 mm in length, scores 0-100, with the right end (0) defined as the no anxiety and the left end (100) as the worst or extremely anxious. This scale was completed by patients and measured by researchers using a ruler. | Mean | Standard Deviation | units on a scale |
|
| Surgery type | Count of Participants | Participants |
|
| OG001 | Preoperative Post-acupuncture | Participants in the acupuncture group completed the Visual Analog Scale for anxiety 30 minutes after having the acupuncture procedure |
|
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| 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. | Total mean pain in the first 3 postoperative hours | Posted | Mean | Standard Deviation | score on a scale | Total mean pain in the first 3 postoperative hours |
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| 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. | Posted | Count of Participants | Participants | Within 1 week after hospital discharge |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Prior to acupuncture and 30 minutes after acupuncture |
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| 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. | Posted | Mean | Standard Deviation | Morphine MilliEquivalent | During hospitalization, up to 24 hours post surgery |
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| 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. | Posted | Mean | Standard Deviation | milligrams | During hospitalization, up to 24 hours post surgery |
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| 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. | Posted | Count of Participants | Participants | Within 1 week after hospital discharge |
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| 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. | Posted | Count of Participants | Participants | At 1 postoperative hour |
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| Secondary | Antiemetic Medications | The frequency of any antiemetic medication given at any time throughout hospitalization up to 24 postoperative hours | Posted | Median | Inter-Quartile Range | number of doses | During hospitalization, up to 24 hours post surgery |
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| Secondary | Hospital Length of Stay | Using the hospital admission and discharge dates & times; this will be compared between the two groups. | Posted | Median | Inter-Quartile Range | hours | From the date and time of admission to the date and time of discharge, assessed as 24-48 hours |
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| 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. | Mean pain scores upon arrival to the PACU between the groups | Posted | Mean | Standard Deviation | score on a scale | Postoperative pain at time of PACU arrival |
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| 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. | Using the mean of pain scores reported by participants at the first postoperative hour | Posted | Mean | Standard Deviation | score on a scale | At the first postoperative hour |
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| 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. | Using the mean pain scores after three postoperative hours between groups | Posted | Mean | Standard Deviation | score on a scale | After three postoperative hours |
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| 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. | Posted | Count of Participants | Participants | During hospitalization up to 24 postoperative hours |
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| 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. | Each frequency represented the percentage of patients in the group who were satisfied (given a score of 9 or 10 out of 10) | Posted | Count of Participants | Participants | Within 1 week after hospital discharge |
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| 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. | Posted | Count of Participants | Participants | Within 1 week after hospital discharge |
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| 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. | Posted | Count of Participants | Participants | Within 1 week after hospital discharge |
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| 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. | Posted | Count of Participants | Participants | After 3 postoperative hours |
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| 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) | Posted | Mean | Standard Deviation | score on a scale | Mean pain scores at arrival to Post-Anesthesia Care Unit, 1st Postoperative hour, and 3rd Postoperative hour |
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| 0 |
| 30 |
| 0 |
| 30 |
| 13 |
| 30 |
| EG001 | Control Group | Patients who did not receive the preoperative acupuncture procedure. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Discomfort | Surgical and medical procedures | Systematic Assessment | Discomfort during the acupuncture procedure |
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| Residual pain | Surgical and medical procedures | Systematic Assessment | Mild pain after removing the acupuncture needles |
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Not provided
Not provided
| 3hr post-operation |
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