Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Virtual Reality
- Sponsor
- Wolfson Medical Center
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Change in pain severity
- Last Updated
- 4 years ago
Overview
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.
Investigators
ilia kleiner
Obstetrics and Gynecology Resident, MD, Principal investigator
Wolfson Medical Center
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
Outcomes
Primary Outcomes
Change in pain severity
Time Frame: 1 hour
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.
Secondary Outcomes
- Change in Anxiety state(1 hour)