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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | patients undergoing one of the procedures without using VR device | |
| VR without sound | Active Comparator | patients undergoing one of the procedures using VR device without sound |
|
| VR with sound | Active Comparator | patients undergoing one of the procedures using VR device with sound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR without positive psychology | Device | Using VR goggles showing relaxing short videos without sound |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noa glick fishman, MD | Contact | 0544443952 | 972 | noagl@assuta.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Noa glick fishman, MD | Assuta Ashdod | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26780039 | Background | Koyyalamudi V, Sidhu G, Cornett EM, Nguyen V, Labrie-Brown C, Fox CJ, Kaye AD. New Labor Pain Treatment Options. Curr Pain Headache Rep. 2016 Feb;20(2):11. doi: 10.1007/s11916-016-0543-2. | |
| 21041955 | Background | Woolf CJ. What is this thing called pain? J Clin Invest. 2010 Nov;120(11):3742-4. doi: 10.1172/JCI45178. Epub 2010 Nov 1. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| VR with positive psychology | Device | Using VR goggles showing relaxing short videos with positive psychological messages |
|
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 |
| 31094789 | Background | Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649. |
| 32485759 | Background | Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2. |