P6 Acupressure Before Laparoscopic Cholecystectomy

NCT ID: NCT02510183

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

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.

Conditions

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Postoperative Complications Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Acupressure Wrist Band

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

Placebo Acupressure Wrist Band

Intervention Type DEVICE

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

Control Grup Without Band

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Placebo Acupressure Wrist Band

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

Intervention Type DEVICE

Other Intervention Names

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Sea Band

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emine Iyigun, Assoc.Prof.

Role: STUDY_CHAIR

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

Mehmet F CAN, Assoc.Prof.

Role: STUDY_CHAIR

Gulhane Military Medical Academy, Department of General Surgery

Sibel Yilmaz Sahin, PhDs

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type BACKGROUND
PMID: 25276717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12067865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16935735 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16261854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19370583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23350886 (View on PubMed)

Other Identifiers

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GulhaneMMA

Identifier Type: -

Identifier Source: org_study_id

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