The Effect of Virtual Reality Glasses on Pain and Anxiety
Primary Purpose
Pain and Anxiety
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Virtual reality glasses and Lidocaine
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Pain and Anxiety
Eligibility Criteria
Inclusion Criteria:
- Iranian
- low risk pregnancy
- Apgar ≥ 7
Exclusion Criteria:
- vision or ear disorders
- History of motion sickness or headaches
- psychological disease or Addiction
- Prescribe narcotic or sedation 4hour prior to delivery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
virtual reality glasses and Lidocaine
Lidocaine
Arm Description
virtual reality glasses and 5 ml Lidocaine 2%
5 cc Lidocaine2%
Outcomes
Primary Outcome Measures
Virtual reality glasses decreased pain and anxiety during episiotomy
Secondary Outcome Measures
Full Information
NCT ID
NCT01659359
First Posted
August 4, 2012
Last Updated
August 7, 2012
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01659359
Brief Title
The Effect of Virtual Reality Glasses on Pain and Anxiety
Official Title
Vice-presidency for Research
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 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
In recent studies using virtual reality has been proposed as a non pharmacological methods for pain relief but until this time , its effects has not been assessed on pain and anxiety during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain and anxiety in Primiparity women during episiotomy repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain and Anxiety
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
virtual reality glasses and Lidocaine
Arm Type
Experimental
Arm Description
virtual reality glasses and 5 ml Lidocaine 2%
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
5 cc Lidocaine2%
Intervention Type
Device
Intervention Name(s)
Virtual reality glasses and Lidocaine
Intervention Description
The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
Primary Outcome Measure Information:
Title
Virtual reality glasses decreased pain and anxiety during episiotomy
Time Frame
up to 8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Iranian
low risk pregnancy
Apgar ≥ 7
Exclusion Criteria:
vision or ear disorders
History of motion sickness or headaches
psychological disease or Addiction
Prescribe narcotic or sedation 4hour prior to delivery.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Virtual Reality Glasses on Pain and Anxiety
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