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The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain

Primary Purpose

Acute Pain, Injection, Needle Phobia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pain

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) of 18.5 to 29.9kg/m2
  • Voluntariness

Exclusion Criteria:

  • history of IM injection within 2 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Acupressure

    Control group

    Arm Description

    Acupressure is applied before injection

    acupressure is not applied before injection

    Outcomes

    Primary Outcome Measures

    Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale)
    Assessment of pain during intramuscular injection will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2018
    Last Updated
    June 11, 2018
    Sponsor
    Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03553901
    Brief Title
    The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain
    Official Title
    The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain - A Crossover Randomized Single-blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    August 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain, Injection, Needle Phobia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupressure
    Arm Type
    Experimental
    Arm Description
    Acupressure is applied before injection
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    acupressure is not applied before injection
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupressure
    Intervention Description
    Acupressure was performed before the injection onto GB30 point
    Primary Outcome Measure Information:
    Title
    Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale)
    Description
    Assessment of pain during intramuscular injection will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured
    Time Frame
    2 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Body Mass Index (BMI) of 18.5 to 29.9kg/m2 Voluntariness Exclusion Criteria: history of IM injection within 2 weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gökhan inangil
    Organizational Affiliation
    Sultan Abdulhamid Han
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    24554956
    Citation
    Suhrabi Z, Taghinejad H. Effect of acupressure (UB32) on pain intensity in intramuscular injections. Iran J Nurs Midwifery Res. 2014 Jan;19(1):24-7.
    Results Reference
    background
    PubMed Identifier
    26536327
    Citation
    Hosseinabadi R, Biranvand S, Pournia Y, Anbari K. The Effect of Acupressure on Pain and Anxiety Caused by Venipuncture. J Infus Nurs. 2015 Nov-Dec;38(6):397-405. doi: 10.1097/NAN.0000000000000065.
    Results Reference
    background
    PubMed Identifier
    12100641
    Citation
    Chung JW, Ng WM, Wong TK. An experimental study on the use of manual pressure to reduce pain in intramuscular injections. J Clin Nurs. 2002 Jul;11(4):457-61. doi: 10.1046/j.1365-2702.2002.00645.x.
    Results Reference
    background

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    The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain

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