Laparoscopic Surgery Clinical Trial
Official title:
Effects of Auricular Pellet Acupressure on the Prevention of Postoperative Nausea and Vomiting Among Women With Gynecological Surgeries
NCT number | NCT05540236 |
Other study ID # | CGH-P110019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2021 |
Est. completion date | May 20, 2022 |
Verified date | July 2022 |
Source | Cathay General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Auricular acupressure is easily accessible and easily performed, and can significantly relieve PONV symptoms, and improve patient's satisfaction in women receiving general anesthesia for gynecological surgeries. This makes it an economically-beneficial supplemental therapy, worthy of promoting for patients receiving general anesthesia.
Status | Completed |
Enrollment | 82 |
Est. completion date | May 20, 2022 |
Est. primary completion date | May 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - 20-50years,Female - ASA(Amersican Society of Anesthesiologists):I or II - Gynecological laparoscopic patients receiving general anesthesia with endotracheal tube and volatile anesthetics (Desflurane or Sevoflurane) - Clear consciousness, willing and able to sign permit agreeing to participate in the study Exclusion Criteria: - Allergic skin condition or damaged skin at planned auricular pellet site. - Unplanned admission to Intensive Care Unit - Retained endotracheal tube upon entry to post-operative care unit - Postoperative use of patient-controlled analgesia - Diagnosis of malignancy - Anti-emetics: Use of Novamin of 3 or more times. - Patient who fulfill the criteria of Non-smoker, motion sickness, and history of PONV |
Country | Name | City | State |
---|---|---|---|
Taiwan | Cathay General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Cathay General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rhodes Index of Nausea, Vomiting, and Retching | This tool is divided into self-assessment and observation, with 8 total questions, each with 5 score values (0 to 4 points), for a maximum score of 32 points. 3 of the questions evaluate the amount, frequency and severity of vomiting, accounting for up to 12 points. 3 of the questions evaluate the frequency and severity of nausea, accounting for up to 12 points. 2 of the questions evaluate the frequency and severity of retching, accounting for up to 8 points. The higher the total score, the more severe the symptoms. The Cronbach's alpha of the original tool is 0.89-0.97, the Cronbach's alpha of prospective studies was 0.85 (Rhodes & McDaniel, 1999), while the Cronbach's alpha of Chou et al. (2005) for the Chinese version of the Rhodes Index of Nausea, Vomiting and Retching(RINV) was 0.94, with content validity index (CVI) of 1.0. | 24hours after ear auricular acupressure | |
Secondary | Hospital Anxiety and Depression Scale: Anxiety- (HADS-A) | The tool was developed by Zigmond and Snaith in 1983, with a total of 14 questions, comprising of two subsets, one for anxiety (HADS-A) and one for depression (HADS-D) both with 7 questions. In the UK and other European countries, many studies show that the Cronbach's alpha for cancer patients was 0.81-0.90. Domestically, Chen et al.'s use of the Chinese version showed Cronbach's alpha of 0.82 for the anxiety assessment tool (HADS-A) and 0.77 for the depression assessment tool (HADS-D), with retest reliability of r = 0.64-0.83(p<0.0l)one week afterwards. Using the 4-Point Likert Scale to evaluate anxiety and depression, the two assessment tools score 0-21 points, with higher points indicating higher levels of anxiety and depression. This study uses HADS-A to assess the anxiety level of patients before and after surgery. | 24hours after ear auricular acupressure | |
Secondary | Post-anesthesia care satisfaction | This study uses 0-10 points visual analogue scale to quantify satisfaction levels of women receiving post-anesthesia management of nausea and vomiting, with higher score representing better satisfaction with the nursing care that was received. | 24hours after ear auricular acupressure |
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