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NCT Number: NCT06954935

Periorbital Massage for Nausea and Vomiting After Laparoscopic Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Albayram

Gaziantep, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

periorbital massage

Other

An electronic eye massager (irest manufacturing company, China) will be applied. The massager has a vibration function and massages with a warm air bag.

Primary outcomes

  1. Apfel risk score

    Time frame: It will be filled half an hour before you go down for surgery.

    : 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.

  2. Numerical Scale of Nausea

    Time frame: 0, 2, 6, 12 and 24 hours after surgery

    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.

  3. Postoperative Nausea and Vomiting Impact Scale

    Time frame: 0, 2, 6, 12 and 24 hours after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

çağla toprak

CONTACT

[email protected]

532 799 78 14

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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