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
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
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
NCT ID
NCT01687933
First Posted
August 29, 2012
Last Updated
September 15, 2012
Sponsor
Mashhad University of Medical Sciences
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
Learn more about this trial
The Effect of Virtual Reality Glasses on Labor Pain
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