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Completed

NCT Number: NCT05760040

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vırtual reality

Other

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.

Control Group

Other

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 8, 2023
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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