Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures

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

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-09-01

Brief Summary

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A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.

After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.

Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.

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Detailed Description

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Conditions

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Virtual Reality Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

patients undergoing one of the procedures without using VR device

Group Type NO_INTERVENTION

No interventions assigned to this group

VR without sound

patients undergoing one of the procedures using VR device without sound

Group Type ACTIVE_COMPARATOR

VR without positive psychology

Intervention Type DEVICE

Using VR goggles showing relaxing short videos without sound

VR with sound

patients undergoing one of the procedures using VR device with sound

Group Type ACTIVE_COMPARATOR

VR with positive psychology

Intervention Type DEVICE

Using VR goggles showing relaxing short videos with positive psychological messages

Interventions

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VR without positive psychology

Using VR goggles showing relaxing short videos without sound

Intervention Type DEVICE

VR with positive psychology

Using VR goggles showing relaxing short videos with positive psychological messages

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
* amniocintesis -single tone,gestional age 16-24 week,
* hysteroscopy-women age 18-60 , diagnostic procedure,

Exclusion Criteria

* ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
* amniocintesis- Known fetal malformations, amnionitis
* hysteroscopy-pregnancy, PID

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes