- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659359
The Effect of Virtual Reality Glasses on Pain and Anxiety
August 7, 2012 updated by: Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
Vice-presidency for Research
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: virtual reality glasses and Lidocaine
virtual reality glasses and 5 ml Lidocaine 2%
|
The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
|
|
Experimental: Lidocaine
5 cc Lidocaine2%
|
The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Virtual reality glasses decreased pain and anxiety during episiotomy
Time Frame: up to 8 months
|
up to 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 4, 2012
First Submitted That Met QC Criteria
August 4, 2012
First Posted (Estimate)
August 7, 2012
Study Record Updates
Last Update Posted (Estimate)
August 8, 2012
Last Update Submitted That Met QC Criteria
August 7, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- virtual reality glasses
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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