VR Glasses During Induction of Labour for Pain and Anxiety Relieve

NCT05187247 | Unknown

• 1 other identifier: 0156-21-WOMC
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter

Conditions

Virtual Reality; Induction of Labor Affected Fetus / Newborn; Extra Amniotic Balloon

Keywords

Virtual reality; Induction of Labor; Extra amniotic Balloon

Outcome Measures

Primary Outcomes (1)

• Change in pain severity

  Subjective assessment of the degree of pain would be graded according to the VAS (Visual Analogue Scale) which is a scale used to measure subjective pain intensity according to a pain scale of 0 to 10, An objective pain assessment will be performed by measuring a pulse at a predetermined time points.

  1 hour

Secondary Outcomes (1)

• Change in Anxiety state

  1 hour

Study Arms (2)

VR group

EXPERIMENTAL

Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure

Device: Virtual Reality glasses

control group

NO INTERVENTION

control group for the intervention group

Interventions

Virtual Reality glasses DEVICE

use of virtual reality glasses to reduce anxiety and pain levels

VR group

Eligibility Criteria

• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women going through mechanical induction of labour with Extra-Amniotic Balloon

You may not qualify if:

• Women with history of migraine, headache, epilepsy, vestibular disorders
• Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

Related Publications (4)

• Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

  PMID: 22419342 BACKGROUND

• Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097.

  PMID: 30175373 BACKGROUND

• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

  PMID: 23277857 BACKGROUND

• Kleiner I, Mor L, Friedman M, Abeid AA, Shoshan NB, Toledano E, Bar J, Weiner E, Barda G. The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief-a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101222. doi: 10.1016/j.ajogmf.2023.101222. Epub 2023 Nov 10.

  PMID: 37951577 DERIVED

Study Officials

• ilia kleiner, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ilia kleiner, MD

CONTACT

972528305195; kleiner.ilia@gmail.com

Ornit Cohen

CONTACT

97235028346; ORNITC@wmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology Resident, MD, Principal investigator

Model Details: A pregnant women who is designated for induction of labor using an extra-amniotic balloon catheter will complete a STAI questionnaire about the degree of anxiety prior to the procedure. All women then will be randomly assigned to 2 groups according to a randomization table. Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure while the second group will constitute a control group for the intervention group. During the insertion procedure, a subjective assessment of the degree of pain will be performed using VAS score (Visual Analog Scale), and objective pain assessment which will be performed by measuring a pulse at a predetermined time points. At the end of the procedure the women will be asked to answer another anxiety questionnaire. Women in the VR group will also answer a satisfaction questionnaire from the experience

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 11, 2022
• Study Start: November 23, 2021
• Primary Completion: November 1, 2022
• Study Completion: May 31, 2023
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)