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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

About this trial

This is an interventional treatment trial for Pain and Anxiety

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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

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

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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