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P6 Acupressure Before Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Complications, Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupressure Wrist Band
Placebo Acupressure Wrist Band
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Acupressure, Perioperative Care, Postoperative Nausea and Vomiting, Nursing Care Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    Acupressure Wrist Band

    Placebo Wrist Band

    Control Grup Without Band

    Arm Description

    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

    Patient receive preoperative education a day before surgery, an placebo acupressure wrist band is applied in both wrist an hour before surgery

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 28, 2015
    Last Updated
    July 26, 2015
    Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02510183
    Brief Title
    P6 Acupressure Before Laparoscopic Cholecystectomy
    Official Title
    Evaluation of the Effects of P6 Acupressure Application on Postoperative Nausea and Vomiting Before Laparoscopic Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complications, Postoperative Nausea and Vomiting
    Keywords
    Acupressure, Perioperative Care, Postoperative Nausea and Vomiting, Nursing Care Management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    111 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupressure Wrist Band
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Placebo Wrist Band
    Arm Type
    Placebo Comparator
    Arm Description
    Patient receive preoperative education a day before surgery, an placebo acupressure wrist band is applied in both wrist an hour before surgery
    Arm Title
    Control Grup Without Band
    Arm Type
    No Intervention
    Arm Description
    Patient receive preoperative education a day before surgery, and patient are only visited an hour before surgery
    Intervention Type
    Device
    Intervention Name(s)
    Acupressure Wrist Band
    Other Intervention Name(s)
    Sea Band
    Intervention Description
    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
    Intervention Name(s)
    Placebo Acupressure Wrist Band
    Intervention Description
    Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.
    Primary Outcome Measure Information:
    Title
    Acupressure affect on Postoperative Nausea, Vomiting and medication need
    Description
    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.
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    Pain measured by 0-10 scoring (0- no pain,10- pain as bad as can be) on 2nd, 6th and 24th hours postoperative.
    Time Frame
    24 hours postoperatively
    Title
    Perioperative Stress
    Description
    Perioperative Stress measured by State-Trait Anxiety Inventory (STAI) score on day before surgery and day after surgery
    Time Frame
    48 hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emine Iyigun, Assoc.Prof.
    Organizational Affiliation
    Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mehmet F CAN, Assoc.Prof.
    Organizational Affiliation
    Gulhane Military Medical Academy, Department of General Surgery
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sibel Yilmaz Sahin, PhDs
    Organizational Affiliation
    Gulhane Military Medical Academy, School of Nursing, Department of Surgical Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25276717
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12067865
    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. doi: 10.1007/BF03017380.
    Results Reference
    background
    PubMed Identifier
    16935735
    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. doi: 10.1016/j.jopan.2006.06.003. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16261854
    Citation
    Hickman AG, Bell DM, Preston JC. Acupressure and postoperative nausea and vomiting. AANA J. 2005 Oct;73(5):379-85.
    Results Reference
    background
    PubMed Identifier
    19370583
    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.
    Results Reference
    background
    PubMed Identifier
    23350886
    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.
    Results Reference
    background

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    P6 Acupressure Before Laparoscopic Cholecystectomy

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