NCT01659359

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

August 4, 2012

Last Update Submit

August 7, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Virtual reality glasses decreased pain and anxiety during episiotomy

    up to 8 months

Study Arms (2)

virtual reality glasses and Lidocaine

EXPERIMENTAL

virtual reality glasses and 5 ml Lidocaine 2%

Device: Virtual reality glasses and Lidocaine

Lidocaine

EXPERIMENTAL

5 cc Lidocaine2%

Drug: Lidocaine

Interventions

The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.

virtual reality glasses and Lidocaine

The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.

Lidocaine

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Iranian
  • low risk pregnancy
  • Apgar ≥ 7

You may not qualify if:

  • vision or ear disorders
  • History of motion sickness or headaches
  • psychological disease or Addiction
  • Prescribe narcotic or sedation 4hour prior to delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 4, 2012

First Posted

August 7, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08