Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide

NCT ID: NCT04491149

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-03-31

Brief Summary

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Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.

The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.

Detailed Description

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Conditions

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Anxiety Acute Amniocentesis Foeticide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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women using virtual glass during amniocentesis/foeticide

Group Type EXPERIMENTAL

virtual reality glasses

Intervention Type DEVICE

In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.

women undergoing amniocentesis/foeticide

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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virtual reality glasses

In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Women younger than 18 years
* Twin pregnancies
* Women with vertigo
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asaf ha Rofeh, MC

Zrifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ran Svirsky, MD

Role: CONTACT

972-89779000

Facility Contacts

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Ran Svirsky, Doctor of Medicine

Role: primary

+9729779000

Other Identifiers

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#0182-19

Identifier Type: -

Identifier Source: org_study_id