VR Glasses During Induction of Labour for Pain and Anxiety Relieve

Virtual Reality Clinical Trial

Official title:

Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187247
• Other study ID #: 0156-21-WOMC
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2022
• Source: Wolfson Medical Center
• Contact: ilia kleiner, MD
• Phone: 972528305195
• Email: kleiner.ilia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Insertion of Extra-Amniotic Balloon (EAB) is a recommend mechanical method of Induction of labour. This method of induction causes the cervix to dilate through mechanical pressure on the cervix.

During the procedure of insertion the women is lying on her back. Insertion of EAB is performed by conventional means.

The insertion of EAB can involve discomfort, pain and anxiety before and during the procedure.

While there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period.

The "Virtual Reality" (VR) technology is a simple non-invasive technology. The advantage of VR is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. This technology uses processes of sight, and hearing that requires attention.

Many studies have already investigated the use of VR technology in various medical procedures, such as dental treatment, infusion, pediatric treatment, burns, trauma, chemotherapy, diagnostic hysteroscopies and other medical procedures that are common to the patient's experience of pain and anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: May 31, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with history of migraine, headache, epilepsy, vestibular disorders

• Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn
• Virtual Reality

Intervention

Device:
• Virtual Reality glasses
use of virtual reality glasses to reduce anxiety and pain levels

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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;(3):CD009234. doi: 10.1002/14651858.CD009234.pub2. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Anxiety state	Anxiety levels will be measured by a valid questionnaire for assessing situational anxiety called The State-Trait Anxiety Inventory (STAI: Y). This version includes 20 statements which represents feelings that characterize anxiety. Women will be asked to rate them on a scale between 1 to 4. The final score in each questionnaire is obtained by summarizing all the ratings. A higher score indicates a higher level of anxiety.	1 hour