P6 Acupressure Before Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Complications, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Device: Acupressure Wrist Band
* Device: Placebo Acupressure Wrist Band


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupressure Wrist Band<br>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<br>* 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.<br>* Other names: Sea Band;|
| Placebo Comparator: Placebo Wrist Band<br>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<br>* Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.<br>|
| No Intervention: Control Grup Without Band<br>Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acupressure affect on Postoperative Nausea, Vomiting and medication need | 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 | 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 | Perioperative Stress measured by State-Trait Anxiety Inventory (STAI) score on day before surgery and day after surgery | 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressure, Perioperative Care, Postoperative Nausea and Vomiting, Nursing Care Management