Effects of Auricular Acupressure on the Management of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgeries

Laparoscopic Surgery Clinical Trial

Official title:

Effects of Auricular Pellet Acupressure on the Prevention of Postoperative Nausea and Vomiting Among Women With Gynecological Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540236
• Other study ID #: CGH-P110019
• Status: Completed
• Phase: N/A
• Start date: July 18, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: July 2022
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background: Post-operative nausea and vomiting (PONV) is common after surgery and anesthesia. Studies have indicated that females receiving gynecological surgeries have a higher incidence of PONV compared to other surgical patients. PONV not only causes discomfort, but may also lead to serious complications, affecting health outcomes. Currently, no single medication has shown universal efficacy for the prevention and treatment of PONV, thus it is empirical for the exploration of non-pharmaceutical methods for PONV management. Purposes: The aim of this study was to explore the efficacy of auricular acupressure on the reduction of PONV, post-operative anxiety, vital signs stability (respiration, heart rate, and blood pressure), and overall improvement of patient satisfaction. Methods: This study design was a randomized clinical trial, with the study population of patients with gynecological laparoscopic surgeries between the ages of 20 to 50, receiving general anesthesia for laparoscopic surgery. A total of 82 patients were enrolled, who were randomly allocated into the control and experimental groups using Microsoft Excel spreadsheet software, with 40 patients in each group, after 2 patients were excluded. Demographic Survey and Hospital Anxiety Scale (Anxiety- HADS-A) were completed prior to surgery. Both group of patients received the auricular pellet acupressure after the first measurement of vital signs upon entry into the post-anesthesia care unit. The control group were given sham intervention of single ear auricular pellet acupressure at the knee(AH4) and thoracic vertebrae(AH11) acupuncture points, while the experimental group were given therapeutic intervention of single ear auricular pellet acupressure at the stomach(CO4), cardia(CO3), liver(CO12), occiput(AT3), shenmen(TF4) and subcortex(AT4) acupuncture points. The Index of Nausea, Vomiting, and Retching (INVR) and vital signs were surveyed 8 hours after surgery. The same was process was repeated 24 hours after surgery, along with Hospital Anxiety Scale (Anxiety- HADS-A) and anesthesia satisfaction surveys. The auricular acupressure were removed after 24 hours. Data was processed using SPSS version 26.0 statistical analysis package software, using independent samples t-test and chi-square test to identify differences between the two groups, and perform post-interventional effectiveness analysis with generalized estimating equations (GEE).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Auricular Acupressure
• Laparoscopic Surgery
• PONV
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• auricular acupressure
The experimental group were given therapeutic intervention of single ear auricular pellet acupressure at the stomach(CO4), cardia(CO3), liver(CO12), occiput(AT3), shenmen(TF4) and subcortex(AT4) acupuncture points
• sham auricular acupressure
The control group were given sham intervention of single ear auricular pellet acupressure at the knee(AH4) and thoracic vertebrae(AH11) acupuncture points

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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