VR Glasses During Induction of Labour for Pain and Anxiety Relieve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2023-05-31

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR group

Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure

Group Type EXPERIMENTAL

Virtual Reality glasses

Intervention Type DEVICE

use of virtual reality glasses to reduce anxiety and pain levels

control group

control group for the intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality glasses

use of virtual reality glasses to reduce anxiety and pain levels

Intervention Type DEVICE

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes