Periorbital Massage for Nausea and Vomiting After Laparoscopic Surgery

Effectiveness of Periorbital Massage in the Management of Nausea and Vomiting After Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. It is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. This study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

Study Overview

• Status: Recruiting
• Conditions: Nausea; Vomiting; Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: periorbital massage

Detailed Description

This study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. One group received periorbital massage, while the other group did not receive massage.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: çağla toprak; Phone Number: 532 799 78 14; Email: cagla.toprak@atlas.edu.tr

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Recruiting
    • Tuğba Albayram

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Those who have laparoscopic cholecystectomy surgery under general anesthesia,

• Those between the ages of 18-70,
• Those who do not have a psychiatric disease,
• Those who understand what they read and volunteer patients,
• Those who do not have a hearing or speech problem,

Exclusion Criteria:

• Patients undergoing emergency surgery,

  • Patients with psychiatric disorders
  • Patients who have taken another antiemetic drug within 24 hours before surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periorbital massage; The severity of nausea and frequency of vomiting of patients will be analyzed at the 2nd, 4th, 6th, 8th, 12th and 24th hours after surgery. 15 minutes before these evaluations, an electronic eye massager (irest manufacturing company, China) will be applied to the patient's eyeball (according to the manufacturer's instructions) for 15 minutes. 15 minutes after the intervention, the severity of nausea and vomiting of patients will be evaluated using the nausea numerical scale and the vomiting incidence evaluation form.	Other: periorbital massage; An electronic eye massager (irest manufacturing company, China) will be applied. The massager has a vibration function and massages with a warm air bag.
No Intervention: control; The severity of nausea and frequency of vomiting of patients will be analyzed at 2, 4, 6, 8, 12 and 24 hours after surgery. Data collection intervals will be the same in both control and intervention groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apfel risk score	: Apfel Risk Score is a simple scoring used to determine the risk status of patients for PONV. Apfel Risk Score questions four factors such as being female, not smoking, having a history of PONV/motion sickness and using postoperative opioids. Each factor is evaluated as 1 point. Apfel risk score varies between 0-4 and is classified as low, medium and high risk. Apfel Risk score 0-1 is evaluated as low risk, 2 as medium risk and 3-4 as high risk.	It will be filled half an hour before you go down for surgery.
Numerical Scale of Nausea	The numerical scale of nausea is a scale that starts with "0 (no nausea)" and ends with "10 (very severe nausea)" and is given a numerical value with 1 cm intervals. The numerical scale is one-dimensional and is mainly used to evaluate the severity of pain.	0, 2, 6, 12 and 24 hours after surgery
Postoperative Nausea and Vomiting Impact Scale	There are four options in the two-question scale, each with 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if any, and the frequency; the answers are "0" no, "1" once, "2" twice, "3" three times or more, with four options. The second question asks whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), if any, whether the feeling of nausea affects your ability to get out of bed, move around comfortably in bed, walk normally, or your daily life activities such as eating and drinking; the answers are "0" not very often, "1" sometimes, "2" often or often, and "3" always, with four options. The numerical values of the answers given to the first and second questions are added up and the result is found.	0, 2, 6, 12 and 24 hours after surgery

Collaborators and Investigators

• Sponsor: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): August 25, 2025
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: nausea; voming; periorbital massage
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 23.12.2024 10/3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No