The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients

March 8, 2023 updated by: Nurdan Demirci, Marmara University

The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients During Intrauterine Device (Iud) Insertion

Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years. According to the researchers' hypotheses, Virtual Reality acts as a non-pharmacological method, using cognitive and attentional processes on the body's complex pain modulation system. Although the neurobiological mechanisms have not been fully explained in studies, it has been reported that virtual reality applications have positive results in pain management. When patients feel that they are in the image, their attention is effectively distracted from the pain. Thus, the existing perception of pain decreases.

In recent years, virtual reality as a distraction application has been used in clinical medical care to relieve pain. Virtual Reality applications; There are studies showing its effectiveness in pain and anxiety management in many areas such as burn debridement, injection applications, wound care, toothache, endoscopy procedure, phantom and chronic pain, and chemotherapy applications.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Not having any psychiatric disease,
  • Having no vision, hearing and perception problems,
  • At least primary school graduate,
  • Can read and write Turkish,
  • Hemodynamically stable,
  • No previous experience of intrauterine device application women

Exclusion Criteria:

  • Under 18 years old,
  • Having any psychiatric disease,
  • Having vision, hearing and perception problems,
  • Illiterate,
  • Hemodynamically unstable,
  • Women who have had an intrauterine device before

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality (VR)
During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.
Other: vırtual reality
During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.
Experimental: Control group
Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.
Other: Control Group
Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analoque Scale =VAS
Time Frame: The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value "0" at the beginning level defines painlessness, and the value "10" at the end level defines the most severe pain
pain
The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value "0" at the beginning level defines painlessness, and the value "10" at the end level defines the most severe pain

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait-Anxiety-Inventory
Time Frame: The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.
Anxiety
The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Scale
Time Frame: It is a form consisting of Likert-type questions to determine the satisfaction levels of women prepared by the researchers in line with the literature.
satisfaction
It is a form consisting of Likert-type questions to determine the satisfaction levels of women prepared by the researchers in line with the literature.

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Principal Investigator: tuğba öz, Marmara University

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)

July 15, 2022

Primary Completion (Actual)

October 7, 2022

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

February 25, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MarmaraU-OZ-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

can be shared after the publication of the article.

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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