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VR Glasses During Induction of Labour for Pain and Anxiety Relieve

W

Wolfson Medical Center (WMC)

Status

Unknown

Conditions

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

Treatments

Device: Virtual Reality glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT05187247
0156-21-WOMC

Details and patient eligibility

About

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

Full 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.

Enrollment

145 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 2 patient groups

VR group
Experimental group
Description:
Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure
Treatment:
Device: Virtual Reality glasses
control group
No Intervention group
Description:
control group for the intervention group

Trial contacts and locations

1

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Central trial contact

ilia kleiner, MD; Ornit Cohen

Data sourced from clinicaltrials.gov

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