P6 Acupressure Before Laparoscopic Cholecystectomy

July 26, 2015 updated by: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Evaluation of the Effects of P6 Acupressure Application on Postoperative Nausea and Vomiting Before Laparoscopic Cholecystectomy

This study is to evaluate the effect of preoperative acupressure application on Postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of being in high risk group for PONV.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prevention of postoperative complications is one of the main tasks of nurses. However, there are limited nursing interventions that can be done to prevent PONV. The American Society of PeriAnesthesia Nurses suggest nurses to teach patients with a high risk of PONV about acupressure application on P6 acupoint or to apply acupressure wristbands preoperatively. However this suggestion has a low evidence.

Study Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient undergoing elective laparoscopic cholecystectomy
  • Patients who make their admission the day before surgery
  • Patients with American Society of Anesthesiologists (ASA) physical status classification system I and II
  • Patient who gave written consent to participate in the study

Exclusion Criteria:

  • Patient who undergone urgent laparoscopic cholecystectomy
  • Patients who make their admission on the day of surgery
  • Patients with who do not conform physical status of ASA I and II
  • Patients who loss single or both upper extremity
  • Patients with open wounds, scar tissue or infection on wrist in acupressure application area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupressure Wrist Band
Patient receive preoperative education a day before surgery, education for acupressure application on the day of surgery, an acupressure wrist band is applied on P6 acupoint in both wrist an hour before surgery
Device: Acupressure Wrist Band
Acupressure wrist band is a knitted elasticated wrist band, which operates by applying pressure on the P6 acupressure point on each wrist by means of a plastic stud.
Other Names:
  • Sea Band
Placebo Comparator: Placebo Wrist Band
Patient receive preoperative education a day before surgery, an placebo acupressure wrist band is applied in both wrist an hour before surgery
Device: Placebo Acupressure Wrist Band
Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.
No Intervention: Control Grup Without Band
Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acupressure affect on Postoperative Nausea, Vomiting and medication need
Time Frame: 24 hours postoperatively
Postoperative nausea, vomiting and medication need are assessed on 2nd, 6th and 24th hours postoperative. Nausea severity measured by 0-10 scoring (0- no nausea,10- nausea as bad as can be), and vomiting is assessed as episodes. Number of antiemetics and analgesics medications that are given (out of routine therapy) are also evaluated.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 24 hours postoperatively
Pain measured by 0-10 scoring (0- no pain,10- pain as bad as can be) on 2nd, 6th and 24th hours postoperative.
24 hours postoperatively
Perioperative Stress
Time Frame: 48 hour
Perioperative Stress measured by State-Trait Anxiety Inventory (STAI) score on day before surgery and day after surgery
48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

  • Study Chair: Emine Iyigun, Assoc.Prof., Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
  • Study Chair: Mehmet F CAN, Assoc.Prof., Gulhane Military Medical Academy, Department of General Surgery
  • Principal Investigator: Sibel Yilmaz Sahin, PhDs, Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GulhaneMMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on Acupressure Wrist Band

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe