search
Back to results

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

Primary Purpose

Laparoscopic Surgery, PONV, Auricular Acupressure

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
auricular acupressure
sham auricular acupressure
Sponsored by
Cathay General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Surgery focused on measuring gynecological laparoscopic surgery, auricular acupressure, complementary therapy, PONV, general anesthesia

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cathay General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The experimental group were given therapeutic intervention

The control group were given sham intervention

Arm Description

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 control group were given sham intervention of single ear auricular pellet acupressure at the knee(AH4) and thoracic vertebrae(AH11) acupuncture points

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 14, 2022
Last Updated
September 12, 2022
Sponsor
Cathay General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05540236
Brief Title
Effects of Auricular Acupressure on the Management of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgeries
Official Title
Effects of Auricular Pellet Acupressure on the Prevention of Postoperative Nausea and Vomiting Among Women With Gynecological Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cathay General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, PONV, Auricular Acupressure
Keywords
gynecological laparoscopic surgery, auricular acupressure, complementary therapy, PONV, general anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental group were given therapeutic intervention
Arm Type
Experimental
Arm Description
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
Arm Title
The control group were given sham intervention
Arm Type
Placebo Comparator
Arm Description
The control group were given sham intervention of single ear auricular pellet acupressure at the knee(AH4) and thoracic vertebrae(AH11) acupuncture points
Intervention Type
Other
Intervention Name(s)
auricular acupressure
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
sham auricular acupressure
Intervention Description
The control group were given sham intervention of single ear auricular pellet acupressure at the knee(AH4) and thoracic vertebrae(AH11) acupuncture points
Primary Outcome Measure Information:
Title
Rhodes Index of Nausea, Vomiting, and Retching
Description
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.
Time Frame
24hours after ear auricular acupressure
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale: Anxiety- (HADS-A)
Description
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.
Time Frame
24hours after ear auricular acupressure
Title
Post-anesthesia care satisfaction
Description
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.
Time Frame
24hours after ear auricular acupressure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs