Labor PainPhase 2/3NCT01687933
The Effect of Virtual Reality Glasses on Labor Pain
A Phase 2/3 study testing three-dimensional glasses(manufactor Vuzix,wrap 920) in people with Labor Pain and Anxiety, run by Mashhad University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Anxiety
- What is being tested?
- three-dimensional glasses(manufactor Vuzix,wrap 920)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Aug 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Iranian
- low risk pregnancy
- primipara
Who cannot join
- vision or ear disorders
- History of motion sickness or headaches
- psychological disease or Addiction
About this study
Official title: Principal Investigator
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.
- Conditions
- Labor Pain, Anxiety
- Being tested
- three-dimensional glasses(manufactor Vuzix,wrap 920), usual care
- Keywords
- Labor pain, Virtual reality, the first stage of labor, Pain relief, Simulator
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
usual careOther
Women in Control group did not use the glasses.
| Study group | Role | What they receive |
|---|---|---|
| three-dimensional glasses (Virtual Reality glasses) | Experimental | Women in case group used the glasses for 30 minutes Receives: Device: three-dimensional glasses(manufactor Vuzix,wrap 920) |
| usual care | Experimental | Women in control group did not use the glasses. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain and anxiety
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687933
- Sponsor's protocol ID
- Virtual Reality System
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT01687933
- Acronym / sponsor ID
- Virtual Reality System
- Conditions
- Labor Pain, Anxiety
- Keywords
- Labor pain, Virtual reality, the first stage of labor, Pain relief, Simulator
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| three-dimensional glasses (Virtual Reality glasses) | Experimental | Device: three-dimensional glasses(manufactor Vuzix,wrap 920)Women in case group used the glasses for 30 minutes |
| usual care | Experimental | Other: usual careWomen in control group did not use the glasses. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Iranian
- low risk pregnancy
- primipara
Key exclusion criteria (3 listed)
- vision or ear disorders
- History of motion sickness or headaches
- psychological disease or Addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| three-dimensional glasses(manufactor Vuzix,wrap 920)The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain. | Device | three-dimensional glasses (Virtual Reality glasses) |
| usual careWomen in Control group did not use the glasses. | Other | usual care |
Primary outcome
pain and anxiety
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing three-dimensional glasses(manufactor Vuzix,wrap 920) in people with Labor Pain and Anxiety, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain and anxiety (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.