The Effect of Virtual Reality Glasses on Pain and Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01659359
First received: August 4, 2012
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pain and Anxiety
Device: Virtual reality glasses and Lidocaine
Drug: Lidocaine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vice-presidency for Research

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • Virtual reality glasses decreased pain and anxiety during episiotomy [ Time Frame: up to 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: virtual reality glasses and Lidocaine
virtual reality glasses and 5 ml Lidocaine 2%
Device: Virtual reality glasses and Lidocaine
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%
Drug: Lidocaine
The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Samira Ebrahimzadeh Zagami, Principle Investigator, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01659359     History of Changes
Other Study ID Numbers: virtual reality glasses
Study First Received: August 4, 2012
Last Updated: August 7, 2012
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014