Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures
Study Details
Study Description
Brief Summary
A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology . After signing an informed consent form pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy) will be included in the study.
After randomization in to three arms controles without vr goggles , the intervention group second arm using vr goggles showing short film without sound .Third arm intervention group will use vr goggles with sound a short relaxing sentences taking from the positive psychology.
Before and after the procedure each group will answer pain and anxiety questionnaires adiitionaly at the end of each procedure cortisol level in saliva will be measured.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: controls patient who will undergone one of the procedures without using VR |
|
| Active Comparator: VR without sound patient who will undergone one of the procedures using VR without sound |
Other: VR without sound
using VR googles showing relaxing short videos without sounds
|
| Active Comparator: VR with sound patient who will undergone one of the procedures using VR with sound |
Other: VR with sound
using VR googles showing relaxing short videos with positive psychological audio
|
Outcome Measures
Primary Outcome Measures
- stress cortisol saliva level [up to 5 minutes after the procedure]
each arm after the procedure will be mesured stress cortisol level in saliva
Secondary Outcome Measures
- pain levels [up to 5 minutes after]
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.
- anxiety levels [up to 5 minutes after]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assuta Ashdod Hospital
Investigators
- Principal Investigator: Noa glick fishman, MD, Assuta Ashdod
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 0125-22-AAA