P6 Acupressure Before Laparoscopic Cholecystectomy

NCT02510183 | Unknown

• 1 other identifier: GulhaneMMA
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Complications; Postoperative Nausea and Vomiting

Keywords

Acupressure; Perioperative Care; Postoperative Nausea and Vomiting; Nursing Care Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain

  24 hours postoperatively

• Perioperative Stress

  48 hour

Study Arms (3)

Acupressure Wrist Band

ACTIVE COMPARATOR

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

Placebo Wrist Band

PLACEBO COMPARATOR

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

Control Grup Without Band

NO INTERVENTION

Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery

Interventions

Acupressure Wrist Band DEVICE

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.

Also known as: Sea Band

Acupressure Wrist Band

Placebo Acupressure Wrist Band DEVICE

Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.

Placebo Wrist Band

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Related Publications (6)

• Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.

  PMID: 25276717 BACKGROUND

• Agarwal A, Bose N, Gaur A, Singh U, Gupta MK, Singh D. Acupressure and ondansetron for postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth. 2002 Jun-Jul;49(6):554-60. doi: 10.1007/BF03017380.

  PMID: 12067865 BACKGROUND

• American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.

  PMID: 16935735 BACKGROUND

• Hickman AG, Bell DM, Preston JC. Acupressure and postoperative nausea and vomiting. AANA J. 2005 Oct;73(5):379-85.

  PMID: 16261854 BACKGROUND

• Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.

  PMID: 19370583 BACKGROUND

• Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.

  PMID: 23350886 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  STUDY CHAIR

• Sibel Yilmaz Sahin, PhDs

  Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2015
• First Posted: July 29, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 29, 2015

Record last verified: 2015-06