VR Glasses During Induction of Labour for Pain and Anxiety Relieve

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Virtual Reality glasses


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR group<br>Women assigned to the VR group will use the virtual reality technology throughout the insertion procedure | Device: Virtual Reality glasses<br>* use of virtual reality glasses to reduce anxiety and pain levels<br>|
| No Intervention: control group<br>control group for the intervention group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Induction of Labor, Extra amniotic Balloon