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

Study Overview
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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.

Official Title
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Using Virtual Reality (VR) Technology in Gynecological Procedures

Conditions
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Virtual Reality, Anxiety, Pain

Intervention / Treatment
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* Device: VR without positive psychology
* Device: VR with positive psychology


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>patients undergoing one of the procedures without using VR device | |
| Active Comparator: VR without sound<br>patients undergoing one of the procedures using VR device without sound | Device: VR without positive psychology<br>* Using VR goggles showing relaxing short videos without sound<br>|
| Active Comparator: VR with sound<br>patients undergoing one of the procedures using VR device with sound | Device: VR with positive psychology<br>* Using VR goggles showing relaxing short videos with positive psychological messages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress cortisol saliva level | each arm after the procedure will be mesured stress cortisol level in saliva | up to 5 minutes after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain levels | each arm after the procedure will fill pain questioner. pain questioners using visual analog score. 0- to 10, while 0 is no pain at all, 10 is the worse pain ever felt.the patients will fill the questioner before and after the procedures. | up to 5 minutes after | 
| anxiety levels | each arm after the procedure will fill anxiety questioner. anxiety questioner using the short depression , anxiety and stress scale (DASS-21). the patients will fill the questioners before and after the procedures. | up to 5 minutes after |