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

NCT ID: NCT05540236

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-18
• Study Completion Date: 2022-05-20

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).

Conditions

Laparoscopic Surgery; PONV; Auricular Acupressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The experimental group were given therapeutic intervention

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

Group Type: EXPERIMENTAL

auricular acupressure

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

sham auricular acupressure

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cathay General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cathay General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

CGH-P110019

Identifier Type: -

Identifier Source: org_study_id