VR Glasses During Induction of Labour for Pain and Anxiety Relieve

January 11, 2022 updated by: ilia kleiner, Wolfson Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • H̱olon, Israel
        • Recruiting
        • Wolfson Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety state
Time Frame: 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: ilia kleiner, MD, Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

December 24, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0156-21-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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