NCT01687933

Brief Summary

There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.

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 Feb 2011

Shorter than P25 for phase_2

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

February 1, 2011

Completed
1.4 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
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
Last Updated

September 19, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

August 29, 2012

Last Update Submit

September 15, 2012

Conditions

Labor PainAnxiety

Keywords

Labor painVirtual realitythe first stage of laborPain reliefSimulator

Outcome Measures

Primary Outcomes (1)

  • pain and anxiety

    up to 8 months

Study Arms (2)

three-dimensional glasses (Virtual Reality glasses)

EXPERIMENTAL

Women in case group used the glasses for 30 minutes

Device: three-dimensional glasses(manufactor Vuzix,wrap 920)

usual care

EXPERIMENTAL

Women in control group did not use the glasses.

Other: usual care

Interventions

three-dimensional glasses(manufactor Vuzix,wrap 920)DEVICE

The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.

three-dimensional glasses (Virtual Reality glasses)
usual careOTHER

Women in Control group did not use the glasses.

usual care

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Iranian
  • low risk pregnancy
  • primipara

You may not qualify if:

  • vision or ear disorders
  • History of motion sickness or headaches
  • psychological disease or Addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
MUMS

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 19, 2012

Study Start

February 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

September 19, 2012

Record last verified: 2012-08