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The Effect of Virtual Reality Glasses on Labor Pain

Primary Purpose

Labor Pain, Anxiety

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
three-dimensional glasses(manufactor Vuzix,wrap 920)
usual care
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor pain, Virtual reality, the first stage of labor, Pain relief, Simulator

Eligibility Criteria

18 Years - 29 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Iranian
  • low risk pregnancy
  • primipara

Exclusion Criteria:

  • vision or ear disorders
  • History of motion sickness or headaches
  • psychological disease or Addiction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    three-dimensional glasses (Virtual Reality glasses)

    usual care

    Arm Description

    Women in case group used the glasses for 30 minutes

    Women in control group did not use the glasses.

    Outcomes

    Primary Outcome Measures

    pain and anxiety

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2012
    Last Updated
    September 15, 2012
    Sponsor
    Mashhad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01687933
    Brief Title
    The Effect of Virtual Reality Glasses on Labor Pain
    Official Title
    Principal Investigator
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mashhad University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain, Anxiety
    Keywords
    Labor pain, Virtual reality, the first stage of labor, Pain relief, Simulator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    three-dimensional glasses (Virtual Reality glasses)
    Arm Type
    Experimental
    Arm Description
    Women in case group used the glasses for 30 minutes
    Arm Title
    usual care
    Arm Type
    Experimental
    Arm Description
    Women in control group did not use the glasses.
    Intervention Type
    Device
    Intervention Name(s)
    three-dimensional glasses(manufactor Vuzix,wrap 920)
    Intervention Description
    The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.
    Intervention Type
    Other
    Intervention Name(s)
    usual care
    Intervention Description
    Women in Control group did not use the glasses.
    Primary Outcome Measure Information:
    Title
    pain and anxiety
    Time Frame
    up to 8 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    29 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Iranian low risk pregnancy primipara Exclusion Criteria: vision or ear disorders History of motion sickness or headaches psychological disease or Addiction

    12. IPD Sharing Statement

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    The Effect of Virtual Reality Glasses on Labor Pain

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