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

NCT05540236 | Completed

• 1 other identifier: CGH-P110019
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery; PONV; Auricular Acupressure

Keywords

gynecological laparoscopic surgery; auricular acupressure; complementary therapy; PONV; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hospital Anxiety and Depression Scale: Anxiety- (HADS-A)

  24hours after ear auricular acupressure

• Post-anesthesia care satisfaction

  24hours after ear auricular acupressure

Study Arms (2)

The experimental group were given therapeutic intervention

EXPERIMENTAL

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

Other: auricular acupressure

The control group were given sham intervention

PLACEBO COMPARATOR

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

Other: sham auricular acupressure

Interventions

auricular acupressure 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 experimental group were given therapeutic intervention

sham auricular acupressure OTHER

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

The control group were given sham intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years,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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cathay General Hospital: lead

Study Sites (1)

Cathay General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: September 14, 2022
• Study Start: July 18, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-07

Locations

TW (1)