P6 Acupressure Before Laparoscopic Cholecystectomy

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02510183
• Other study ID #: GulhaneMMA
• Status: Active, not recruiting
• Phase: N/A
• First received: June 28, 2015
• Last updated: July 26, 2015
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Gulhane Military Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Military Medical Academy

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. Update in: Cochrane Database Syst Rev. 2015;11:CD003281. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Perioperative Stress	Perioperative Stress measured by State-Trait Anxiety Inventory (STAI) score on day before surgery and day after surgery	48 hour	No