Clinical trial NCT05187247: VR Glasses During Induction of Labour for Pain and Anxiety Relieve
Official title: Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Virtual Reality
Induction of Labor Affected Fetus / Newborn
Extra Amniotic Balloon
Keywords: Virtual reality
Induction of Labor
Extra amniotic Balloon
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-01-11
Enrollment: 145
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain severity
timeFrame: 1 hour
Secondary outcomes:
measure: Change in Anxiety state
timeFrame: 1 hour
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: ilia kleiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
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.
citation: 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.