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

Pain Clinical Trial

— VR  

Official title:

Using Virtual Reality (VR) Technology in Gynecological Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941390
• Other study ID #: 0125-22-AAA
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2023
• Source: Assuta Ashdod Hospital
• Contact: Noa glick fishman, MD
• Phone: 0544443952
• Email: noagl[@]assuta.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain
• Virtual Reality

Intervention

Device:
• VR without positive psychology
Using VR goggles showing relaxing short videos without sound
• VR with positive psychology
Using VR goggles showing relaxing short videos with positive psychological messages

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Ashdod Hospital

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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