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

Assuta Ashdod Hospital

Status: Not yet enrolling

Conditions: Anxiety; Pain; Virtual Reality

Treatments: Device: VR without positive psychology; Device: VR with positive psychology

Study type: Interventional

Funder types: Other

Identifiers

NCT05941390

0125-22-AAA

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

control

No Intervention group

Description:

patients undergoing one of the procedures without using VR device

VR without sound

Active Comparator group

Description:

patients undergoing one of the procedures using VR device without sound

Treatment:

Device: VR without positive psychology

VR with sound

Active Comparator group

Description:

patients undergoing one of the procedures using VR device with sound

Treatment:

Device: VR with positive psychology